Crohn's Disease
Dual Targeted Drug Therapy for Adults With Moderate to Severe Crohn’s Disease
This study is examining the effects and safety of vedolizumab combined with adalimumab or ustekinumab, followed by vedolizumab alone for participants who benefit, in adults with moderate to severe Crohn’s disease.
Registry title: A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
41 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–70 Years
- Treatment
- Vedolizumab or Adalimumab
- Design
- Non Randomized
- Central study contact
- Takeda Contact+1-877-825-3327medinfoUS@takeda.com
- Sponsor
- Takeda
Research question
What effects and safety outcomes occur when adults with moderate to severe Crohn’s disease receive vedolizumab with adalimumab or ustekinumab, followed by vedolizumab alone when Part A provides therapeutic benefit?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 70 with Crohn’s disease.
- Participants must have had a confirmed Crohn’s disease diagnosis for at least three months before screening.
- The study is looking for people with moderately to severely active disease confirmed by an endoscopic severity score.
- Participants must have had an inadequate response, loss of response, or intolerance to specified prior advanced Crohn’s disease treatment.
- The study is being conducted at multiple sites in the United States and Canada.
Participation overview
What participation may involve
Participants receive one of two vedolizumab-based combination regimens in Part A. Those judged to have therapeutic benefit at Week 26 receive vedolizumab alone in Part B and then complete safety follow-up. What participation may involve: - Cohort 1 receives intravenous vedolizumab through Week 22 and subcutaneous adalimumab through Week 26 on the schedules stated in the registry. - Cohort 2 receives intravenous vedolizumab through Week 22 plus an initial weight-based intravenous ustekinumab dose followed by subcutaneous ustekinumab through Week 24. - Participants with therapeutic benefit in Part A receive intravenous vedolizumab alone every eight weeks from Week 30 through Week 46. - Study assessments include Crohn’s disease symptom scores, patient-reported stool frequency and abdominal pain, ileocolonoscopy-based disease scoring, and fecal calprotectin measurements. The registry estimates approximately 76 weeks of participation, including safety follow-up through Week 72 or 26 weeks after the last study-drug dose.
Study interventions
What participants may receive or do
- Vedolizumab: Vedolizumab is given by intravenous infusion in both Part A combination groups. Participants judged to have therapeutic benefit in Part A receive it alone every eight weeks from Week 30 through Week 46 in Part B.
- Adalimumab: Adalimumab is given by subcutaneous injection with vedolizumab in Part A, Cohort 1, with scheduled doses through Week 26.
- Ustekinumab: In Part A, Cohort 2, the first ustekinumab dose is a weight-based intravenous infusion given with vedolizumab.
- Ustekinumab: After its initial intravenous dose, ustekinumab is given by subcutaneous injection eight weeks later and then every eight weeks through Week 24 in Part A, Cohort 2.
Study design
How the comparison works
This is an open-label, phase 4, non-randomized study with two parallel combination-treatment cohorts in Part A. Participants who show therapeutic benefit at Week 26 may continue into Part B with vedolizumab alone. The registry describes allocation as non-randomized, so assignment to the two Part A treatment cohorts is not reported as being determined by chance. The study has no masking, meaning participants and study staff are not reported as blinded to the assigned treatment. The registry lists two active combination-treatment cohorts and a later vedolizumab-only phase; it does not list a separate untreated or active-comparator control group. No placebo intervention or placebo arm is listed in the registry record.
Reported activities
Procedures and tests
- Intravenous infusions are used to administer vedolizumab and the initial ustekinumab dose.
- Subcutaneous injections are used to administer adalimumab and later ustekinumab doses.
- Ileocolonoscopy is used to calculate the Simple Endoscopic Score for Crohn’s Disease at baseline and at later assessment points including Weeks 26 and 52.
- The Crohn’s Disease Activity Index is assessed using symptoms and clinical information including stool frequency, abdominal pain, general well-being, body weight, hematocrit, and other disease features.
- Participants report stool frequency and abdominal pain for the two-item patient-reported outcome measure.
- Fecal calprotectin concentrations are measured at baseline and Weeks 12, 26, 42, and 52.
- Screening must confirm the absence of active or latent tuberculosis and the hepatitis B and hepatitis C findings excluded by the protocol.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- A Crohn’s disease diagnosis must have been confirmed by endoscopy at least three months before screening.
- At screening, disease must be moderately to severely active, with a Simple Endoscopic Score for Crohn’s Disease of at least 6, or at least 4 for isolated ileal disease.
- Prior treatment history must include inadequate response, loss of response, or intolerance to at least one interleukin antagonist or tumor necrosis factor antagonist approved for Crohn’s disease.
- For entry into Part B, the investigator must judge that the participant had therapeutic benefit at Week 26.
- The registry’s stated age range is 18 through 70 years.
Possible reasons someone may not be able to join
- A Crohn’s Disease Activity Index score above 450 is excluded.
- People with a current diagnosis of ulcerative colitis or indeterminate colitis are excluded.
- An abdominal abscess, certain fistulas or phlegmon, or a perianal fistula with an abscess is excluded.
- An ileostomy, colostomy, or severe or symptomatic intestinal narrowing is excluded.
- Short bowel syndrome or the specified history of extensive bowel resection is excluded.
- A planned Crohn’s disease operation is excluded, except seton placement for a perianal fistula without an abscess.
- People unable to undergo ileocolonoscopy because of intolerance or a contraindication are excluded.
- Active or latent tuberculosis is excluded regardless of prior treatment.
- The protocol excludes the specified positive hepatitis B or hepatitis C test results.
- Prior use of the listed anti-integrin antibodies or rituximab to treat Crohn’s disease is excluded.
Important unknowns
What the record does not make clear
- The registry provides dosing and outcome-assessment weeks but not a complete visit calendar or the expected length of each visit.
- The record does not fully describe which existing Crohn’s disease medicines may continue during the study.
- The record does not provide medication washout periods before study treatment.
- The registry does not state what rescue treatment is allowed if Crohn’s disease worsens.
- The record does not explain which study-related or routine-care costs are paid by the sponsor or billed to insurance.
- Participant payment or reimbursement is not described.
- The registry does not describe transportation, lodging, or other travel assistance.
- The record does not state whether study drugs remain available after study participation ends.
- The overall study and listed locations are marked recruiting, but the record does not confirm that both Part A cohorts have openings at every site.
Before contacting the site
Questions for the study team
- How will the team decide whether I enter the vedolizumab-plus-adalimumab cohort or the vedolizumab-plus-ustekinumab cohort?
- What does “therapeutic benefit” at Week 26 mean, and who makes the decision about entering Part B?
- How many ileocolonoscopies, blood draws, stool samples, and symptom reports are required, and when?
- Which current Crohn’s disease medicines must be continued, changed, or stopped before and during the study?
- What happens if my Crohn’s disease worsens or I do not show therapeutic benefit at Week 26?
- Which study-related costs are covered, and is travel reimbursement or participant compensation available?
- Is the appropriate treatment cohort currently recruiting at my preferred location?
Before changing care
Questions for your gastroenterologist
- How might the study’s combination therapy interact with my current Crohn’s disease medicines and other health conditions?
- How stable is my disease now, and what risks should we consider if my current treatment must change or pause?
- What approved treatment alternatives should I compare with the study’s two combination regimens?
- Are repeated ileocolonoscopies and the study’s other assessments appropriate given my disease location, prior surgery, and overall health?
- How should my regular gastroenterology care be coordinated with the research team if I contact a study site?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderate to severe Crohn's disease who have experienced inadequate response, loss of response or intolerance to either one prior interleukin \[IL\] antagonist, and no other biologic/small molecule (Group A); one IL antagonist and either one Janus kinase inhibitor (JAKi) or one TNFi (other than adalimumab) \[Group B\] (Cohort 1) or one prior tumor necrosis factor inhibitor \[TNFi\] and no other biologic/small molecule (Group C); one TNFi and either 1 JAKi or one IL antagonist (other than UST) (Group D) (Cohort 2). The study will look at the efficacy and safety of dual targeted therapy. The study will enroll approximately 100 participants. Participants will be assigned to one of the two treatment groups in Part A: * Part A, Cohort 1: Vedolizumab + Adalimumab * Part A, Cohort 2: Vedolizumab + Ustekinumab All participants who achieve therapeutic benefit in Part A will receive vedolizumab IV 300 mg monotherapy from Week 30 until Week 46 in Part B. Participants will be followed for a further 20-week safety follow-up period to Week 72 (or 26 weeks post-last dose of study drug). This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 76 weeks.
Study design and administration
- Organization
- Takeda
- Organization class
- Industry
- Organization study ID
- Vedolizumab-4051
- Lead sponsor
- Takeda
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Part A, Cohort 1: Vedolizumab + Adalimumab
Participants will receive vedolizumab IV 300 mg, at Weeks 0, 2, and 6, then every 8 weeks (Q8W) until Week 22 and adalimumab SC 160, 80, and 40 mg at Weeks 0, 2, and 4, respectively, then 40 mg every 2 weeks (Q2W) until Week 26.
Interventions: Drug: Vedolizumab, Drug: Adalimumab
Experimental
Part A, Cohort 2: Vedolizumab + Ustekinumab
Participants will receive vedolizumab IV 300 mg, at Weeks 0, 2, and 6, then Q8W until Week 22 and ustekinumab IV 520, 390, or 260 mg (weight-based), then SC 90 mg 8 weeks after initial IV dose, then Q8W until Week 24.
Interventions: Drug: Vedolizumab, Drug: Ustekinumab
Experimental
Part B: Vedolizumab Monotherapy
Participants who achieve therapeutic benefit in Part A will receive vedolizumab IV 300 mg monotherapy, Q8W from Week 30 until Week 46 and will be followed up to Week 52.
Interventions: Drug: Vedolizumab
Interventions
Drug
Vedolizumab
Vedolizumab intravenous infusion.
Drug
Adalimumab
Adalimumab subcutaneous injection.
Drug
Ustekinumab
Ustekinumab intravenous infusion.
Drug
Ustekinumab
Ustekinumab subcutaneous injection.
Eligibility
18 Years–70 Years
All
Not accepted
Inclusion criteria (8)
- Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results.Registry-derived · unreviewed
- Has moderately to severely active CD at Screening, defined as an SES-CD \>=6 (\>=4 if isolated ileal disease).Registry-derived · unreviewed
- Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved for the treatment of CD:Registry-derived · unreviewed
- Inadequate response after completing the full induction regimen;Registry-derived · unreviewed
- Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); orRegistry-derived · unreviewed
- Intolerance (a significant adverse event that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury).Registry-derived · unreviewed
- Note: Participants with an inadequate response to \>2 classes of advanced therapies or \>1 agent in the same class are not eligible. Participants who discontinued a third class of advanced therapy for reasons other than inadequate response may be eligible after discussion with the Medical Monitor.Registry-derived · unreviewed
- In the investigator's opinion, the participant exhibits a therapeutic benefit at Week 26.Registry-derived · unreviewed
Exclusion criteria (18)
- CDAI score \> 450.Registry-derived · unreviewed
- A current diagnosis of ulcerative colitis or indeterminate colitis.Registry-derived · unreviewed
- Clinical evidence of an abdominal abscess.Registry-derived · unreviewed
- Known fistula (other than perianal fistula) or phlegmon.Registry-derived · unreviewed
- Known perianal fistula with abscess.Registry-derived · unreviewed
- Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.Registry-derived · unreviewed
- Previous extensive bowel resection with 2 entire segments missing, of the following: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.Registry-derived · unreviewed
- Short bowel syndrome.Registry-derived · unreviewed
- Any planned surgical intervention for CD, except for seton placement for perianal fistula without abscess.Registry-derived · unreviewed
- History or evidence of adenomatous colonic polyps that have not been removed.Registry-derived · unreviewed
- History or evidence of colonic mucosal dysplasia.Registry-derived · unreviewed
- Intolerance or contraindication to ileocolonoscopy.Registry-derived · unreviewed
- Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency infection).Registry-derived · unreviewed
- Active or latent tuberculosis (TB), regardless of treatment history.Registry-derived · unreviewed
- A positive test for hepatitis B virus (HBV) as defined by the presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test.Registry-derived · unreviewed
- A positive test for hepatitis C virus (HCV), as defined by a positive hepatitis C virus antibody (HCVAb) test and detectable HCV ribonucleic acid (RNA).Registry-derived · unreviewed
- Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\], anti- mucosal addressin cell adhesion molecule-1 \[MAdCAM-1\] antibodies, or rituximab) for the treatment of CD.Registry-derived · unreviewed
- History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion. If a participant has symptoms consistent with PML, a PML checklist must be completed and submitted to the PML independent adjudication committee. If the PML IAC deems the participant to have PML, the participant is ineligible.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Part A: Percentage of Participants With an Endoscopic Response Based on the Simple Endoscopic Score for (SES-CD) at Week 26
Time frame: At Week 26
Endoscopic response is defined by a \>=50 percent (%) reduction from baseline in the SES-CD. SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of surface area (SA) that is ulcerated, percentage of SA affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.
Primary outcome
Part B: Percentage of Participants With an Endoscopic Response Based on the SES-CD at Week 52
Time frame: At Week 52
Endoscopic response is defined by a \>=50 reduction from baseline in the SES-CD. SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of surface area (SA) that is ulcerated, percentage of SA affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.
Secondary outcome
Percentage of Participants in Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) (CDAI <150) at Week 12, Week 26, and Week 52
Time frame: At Weeks 12, 26, and 52
Clinical remission is defined as a CDAI score of \<150 points. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit and body weight. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity. Percentage of participants in clinical remission based on CDAI at either Week 12, Week 26, or Week 52 will be reported in this outcome measure.
Secondary outcome
Percentage of Participants in Clinical Remission at Both Week 26 and Week 52
Time frame: At Weeks 26 and 52
Clinical remission is defined as a CDAI score of ≤150 points. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit and body weight. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity. Percentage of participants in clinical remission at both Week 26 and Week 52 will be reported in this outcome measure.
Secondary outcome
Percentage of Participants in 2-item Patient-reported Outcome Measure (PRO2) Remission at Weeks 12, 26, and 52
Time frame: At Weeks 12, 26 and 52
Clinical remission based on PRO2 is defined as PRO2 score \<=8 from baseline. The PRO2 is comprised of the stool frequency and abdominal pain components of the CDAI. The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score. The average daily number of liquid or very soft stools and abdominal pain score (with 0 indicating no pain and 3 indicating severe pain) are weighted according to the CDAI multiplication factors (2 for stool frequency and 5 for abdominal pain). A higher score indicates more frequent stools and more severe abdominal pain.
Secondary outcome
Change in PRO2 Score from Week 26 to 52
Time frame: From Week 26 up to Week 52
The PRO2 is comprised of the stool frequency and abdominal pain components of the CDAI. The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score. The average daily number of liquid or very soft stools and abdominal pain score (with 0 indicating no pain and 3 indicating severe pain) are weighted according to the CDAI multiplication factors (2 for stool frequency and 5 for abdominal pain). A higher score indicates more frequent stools and more severe abdominal pain.
Secondary outcome
Percentage of Participants in Stool Frequency Remission
Time frame: At Weeks 12, 26, and 52
Stool frequency remission is defined as an average daily stool frequency of \<=3 that is not worse than baseline.
Secondary outcome
Percentage of Participants in Abdominal Pain Remission
Time frame: At Weeks 12, 26, and 52
Abdominal pain remission is defined as an abdominal pain score of \<=1 that is not worse than baseline.
Secondary outcome
Percentage of Participants in Endoscopic Remission (SES-CD 0-2) at Week 26 and Week 52
Time frame: At Weeks 26 and 52
Endoscopic remission is defined as SES-CD score from 0-2. SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of surface area (SA) that is ulcerated, percentage of SA affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The overall SES-CD score ranges from 0 to 56 and is sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease. Percentage of participants achieving endoscopic remission based on SES-CD at either Week 26 or Week 52 will be reported in this outcome measure.
Secondary outcome
Percentage of Participants in Endoscopic Remission at Both Week 26 and Week 52
Time frame: At Weeks 26 and 52
Endoscopic remission as per SES-CD is defined as SES-CD score from 0-2. SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of surface area (SA) that is ulcerated, percentage of SA affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The overall SES-CD score ranges from 0 to 56 and is sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease. Percentage of participants achieving endoscopic remission based on SES-CD at both Weeks 26 and 52 will be reported in this outcome measure.
Secondary outcome
Percentage of Participants in Deep Remission Based on the CDAI and SES-CD at Week 26 and Week 52
Time frame: At Weeks 26 and 52
Deep remission:CDAI \<150 points and SES-CD 0-2. CDAI assesses CD per clinical signs such as number of liquid/soft stools,abdominal pain,general wellbeing,extra-intestinal manifestations of CD, antidiarrheal use,presence of abdominal mass, hematocrit and body weight. It has 8 factors each summed after adjustment with weighting factor; total score:0 to 600 points, higher scores=more severity. SES-CD evaluates 4 endoscopic variables(ulcer size, percentage of ulcerated surface area, percentage of affected surface area, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. Each variable is coded from 0=none or not severe to 3=most severe case; sum of the scores range from 0 to 15, except for narrowing. Presence of narrowing ranges from 0 to 11. Overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables. Higher scores=more severe disease. Participants achieving deep remission at either Week 26 or 52 will be assessed in this outcome measure.
Secondary outcome
Percentage of Participants in Deep Remission at Both Week 26 and Week 52
Time frame: At Weeks 26 and Week 52
Deep remission: CDAI \<150 points and SES-CD 0-2. CDAI assesses CD per clinical signs such as number of liquid/soft stools,abdominal pain,general wellbeing,extra-intestinal manifestations of CD, antidiarrheal use,presence of abdominal mass, hematocrit and body weight. It has 8 factors each summed after adjustment with weighting factor; total score:0 to 600 points, higher scores=more severity. SES-CD evaluates 4 endoscopic variables(ulcer size, percentage of ulcerated surface area, percentage of affected surface area, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. Each variable is coded from 0=none or not severe to 3=most severe case; sum of the scores range from 0 to 15, except for narrowing. Presence of narrowing ranges from 0 to 11. Overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables. Higher scores=more severe disease. Participants achieving deep remission at both Weeks 26 and 52 will be assessed in this outcome measure.
Secondary outcome
Percentage of Participants With a Clinical Response (>=100-point Decrease from Baseline in CDAI Score)
Time frame: At Weeks 12, 26, and 52
Clinical response is defined as \>=100-point decrease from Baseline in CDAI score. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit and body weight. CDAI consist of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.
Secondary outcome
Percentage of Participants With Complete Endoscopic Healing
Time frame: At Weeks 26 and 52
Complete endoscopic healing is defined as SES-CD score ≤4 with a ≥2-point decrease from baseline and no individual subscore \>1. SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is the most severe case, with the sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.
Secondary outcome
Percentage of Participants Using Oral Corticosteroids at Baseline who are in Clinical Remission Based on CDAI Score and had Discontinued Corticosteroids
Time frame: From Week 26 to Week 52
Percentage of participants using oral corticosteroids at Baseline who are in clinical remission based on the CDAI score and had discontinued corticosteroids within \>=30 days of Week 26 and within \>= 90 days of Week 52. Clinical remission is defined as a CDAI score of ≤150 points. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit and body weight. CDAI consist of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.
Secondary outcome
Change in SES-CD from Baseline to Week 26 and Week 52
Time frame: Baseline, Week 26 and Week 52
SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is the most severe case, with the sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.
Secondary outcome
Percentage of Participants with First CD Exacerbation After 26 Weeks
Time frame: From Week 26 through Week 52
CD exacerbation is defined as a \>70-point increase in CDAI from the prior visit on 2 occasions separated by a 2-week interval, and either CRP above normal or fecal calprotectin \[FCP\] \>250 micrograms per gram (μg/g). CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit and body weight. CDAI consist of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.
Secondary outcome
Change in FCP Concentrations from Baseline to Week 12, Week 26, Week 42, and Week 52
Time frame: Baseline, Weeks 12, 26, 42, and 52
Recruiting locations in the United States
Digestive Health Specialsits
RecruitingDothan, Alabama, 36301, United States
Site Contact334-836-1212Ralbares.research@dothangi.com
Robert Albares
GI Alliance Sun City
RecruitingSun City, Arizona, 85351, United States
Site Contact623-972-2116CTrivedi@arizonadigestivehealth.com
Chirag Trivedi
University of California San Diego Health (UCSD)
RecruitingLa Jolla, California, 92037, United States
Site Contact858-246-2544psinh@health.ucsd.edu
Preetika Sinh
Cedars-Sinai Medical Center
RecruitingLos Angeles, California, 90048, United States
Site Contact310-423-4100Andres.Yarur@cshs.org
Andres Yarur
Hoag Hospital Newport Beach
RecruitingNewport Beach, California, 92663, United States
Site Contact323-442-6151aroline.hwang@usc.edu
Caroline Hwang
Medical Research Center of Connecticut, LLC
RecruitingHamden, Connecticut, 06518, United States
Site Contact203-281-4463pfeuerstadt@gastrocenter.org
Paul Feuerstadt
Clinical Research of Osceola
RecruitingKissimmee, Florida, 34741, United States
Site Contact407-954-4016batiquzzaman@crosceola.com
Basher Atiquzzaman
Endoscopic Research Inc
RecruitingOrlando, Florida, 32803, United States
Site Contact407-896-1726levinepi@cdhfl.com
Henry Levine
Alliance Clinical Research of Tampa, LLC
RecruitingTampa, Florida, 33615, United States
Site Contact813-515-5400crespo@allianceclinicalresearch.com
Israel Crespo
Gastroenterology Consultants, P.C.
RecruitingRoswell, Georgia, 30076, United States
Site Contact404-596-4480Mel7315@Yahoo.com
Melvin Bullock
University of Chicago Medicine
RecruitingChicago, Illinois, 60637, United States
Site Contact177-384-7414kkearney@bsd.uchicago.edu
David Rubin
University of Kansas Medical Center
RecruitingKansas City, Kansas, 66160, United States
Site Contact913-588-3934tesfandyari@kumc.edu
Tuba Esfandyari
Cotton ONeil Clinical Research Center
RecruitingTopeka, Kansas, 66606, United States
Site Contact785-270-4864CUBAUM@stormontvail.org
Curtis Baum
University of Louisville
RecruitingLouisville, Kentucky, 40202, United States
Site Contact502-419-5150gerald.dryden@louisville.edu
Gerald Dryden
GI Alliance
RecruitingMetairie, Louisiana, 70006, United States
Site Contact504-456-8020catinis@metrogi.com
George Catinis
Tulane University
RecruitingNew Orleans, Louisiana, 70112, United States
Site Contact352-265-8971sglover3@tulane.edu
Sarah Glover
Huron Gastroenterology Associates, P.C.
RecruitingYpsilanti, Michigan, 48197, United States
Site Contact734-434-6262soofin@hurongastro.com
Najm Soofi
Mid-America Gastro-Intestinal Consultants
RecruitingKansas City, Missouri, 64111, United States
Site Contact816-561-2000hbownik@gimagic.com
Hillary Bownik
BVL Clinical Research
RecruitingLiberty, Missouri, 64068, United States
Site Contact800-407-9314c.bartalos@bvlresearch.com
Christopher Bartalos
Washington University School of Medicine
RecruitingSt Louis, Missouri, 63110, United States
Site Contact314-273-1947Deepak.parakkal@wustl.edu
Parakkal Deepak
NYU Langone Health
RecruitingNew York, New York, 10016, United States
Site Contact646-754-1899David.Hudesman@nyulangone.org
David Hudesman
University of Cincinnati
RecruitingCincinnati, Ohio, 45627, United States
Site Contact513-558-5504brookln@ucmail.uc.edu
Loren Brook
Ohio Gastroenterology group, Inc.
RecruitingColumbus, Ohio, 43202, United States
Site Contact614-754-5481research@ohiogastro.com
Ryan Gaible
Great Lakes Gastroenterology Research, LLC
RecruitingMentor, Ohio, 44060, United States
Site Contact440-205-1225kafried@roadrunner.com
Keith Alan Friedenberg
Gastro Intestinal Research Institute of Northern Ohio, LLC.
RecruitingWestlake, Ohio, 44145, United States
Site Contact440-250-7630mnaem@northshoregastro.org
Mohamed S Naem
Digestive Disease Specialists, Inc.
RecruitingOklahoma City, Oklahoma, 73114, United States
Site Contact405-702-1246David.Stokesberry@okddsi.net
David Stokesberry
Allegheny Health Network
RecruitingWexford, Pennsylvania, 15090, United States
Site Contact412-359-8900Aakash.desai@ahn.org
Aakash Desai
University Gastroenterology
RecruitingProvidence, Rhode Island, 02094, United States
Site Contact401-421-6306Jason.Ferreira@gialliance.com
Ferreira Jason
Sanford Health Research
RecruitingRapid City, South Dakota, 57701, United States
Site Contact605-342-3280Blake.jones@Sanfordhealth.org
Blake Jones
Texas Digestive Disease Consultants Cedar Park
RecruitingCedar Park, Texas, 78613, United States
Site Contact512-341-0900jsiddiqui@tddctx.com
Junaid Siddiqui
GI Alliance - Digestive Health Associates of Texas
RecruitingDallas, Texas, 75044, United States
Site Contact972-265-8201harry.sarles@gialliance.com
Harry E. Sarles
The University of Texas Health Science Center at Houston
RecruitingHouston, Texas, 77030, United States
Site Contact713-500-6677Andrew.Dupont@uth.tmc.edu
Andrew Dupont
Texas Digestive Disease Consultants Lubbock
RecruitingLubbock, Texas, 79410, United States
Site Contact806-793-3141AHughston@tddctx.com
Adam Hughston
GI Alliance - Mansfield
RecruitingMansfield, Texas, 76063, United States
Site Contact817-877-0888moustafa.youssef@dhat.com
Moustafa Youssef
Gastroenterology Research of San Antonio, LLC
RecruitingSan Antonio, Texas, 78229, United States
Site Contact210-615-3848martinezn2@yahoo.com
Nicholas Martinez
Southern Star Research Institute, LLC.
RecruitingSan Antonio, Texas, 78229, United States
Site Contact210-581-2812Js_bull@yahoo.com
Jeff Bullock
Texas Digestive Disease Consultants (TDDC), Southlake
RecruitingSouthlake, Texas, 76092, United States
Site Contact940-367-2316Tim.Ritter@gialliance.com
Timothy Ritter
Tyler Research Institute, LLC
RecruitingTyler, Texas, 75701, United States
Site Contact903-630-6211Aaron.duvall@iterativehealth.com
George Aaron DuVall
GI Alliance - Webster
RecruitingWebster, Texas, 77598, United States
Site Contact832-754-8163NInamdar@tddctx.com
Nikhil Inamdar
University of Utah Health
RecruitingSalt Lake City, Utah, 84108, United States
Site Contactjohn.valentine@hsc.utah.edu
John Valentine
Washington Gastroenterology- GIA
RecruitingTacoma, Washington, 98405, United States
Site Contact253-272-5127wholderman@washgi.com
William Holderman
This study also lists 7 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Sep 21, 2023
- Primary completion
- Jun 28, 2027
- Overall completion
- Jun 28, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.