Moderately to Severely Active Crohns Disease
Phase 3 Afimkibart Study for Moderately to Severely Active Crohn’s Disease
This Phase 3 study is investigating the efficacy and safety of afimkibart induction and maintenance therapy, compared with placebo, in people with moderately to severely active Crohn’s disease.
Registry title: A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
92 recruiting U.S. sites ↓Study at a glance
- Age
- 16 Years–80 Years
- Treatment
- Afimkibart or Placebo
- Design
- Randomized · Double
- Central study contact
- Reference Study ID Number: GA45331 https://forpatients.roche.com/ No attachments to email below.888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com
- Sponsor
- Hoffmann-La Roche
Research question
How effective and safe is afimkibart as induction and maintenance therapy, compared with placebo, for moderately to severely active Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is looking for people with a confirmed diagnosis of Crohn’s disease.
- The study is looking for people whose Crohn’s disease is moderately to severely active.
- The registry lists an age range of 16 to 80 years and a minimum body weight of 40 kilograms.
- The study is looking for people who had an inadequate response, lost response, or could not tolerate at least one protocol-specified conventional or advanced Crohn’s disease therapy.
Participation overview
What participation may involve
Participants are randomized to one of two afimkibart groups or a placebo group and receive an intravenous infusion followed by under-the-skin injections. The study assesses Crohn’s disease symptoms, endoscopic findings, quality of life, and adverse events. What participation may involve: - Receive afimkibart or matching placebo by intravenous infusion and later by under-the-skin injection. - Complete assessments of stool frequency, abdominal pain, bowel urgency, fatigue, general well-being, overall symptoms, and quality of life. - Undergo assessment of disease activity using the Crohn’s Disease Activity Index and endoscopic scoring. - Be monitored for adverse events, including serious events and events that lead to stopping study treatment.
Study interventions
What participants may receive or do
- Afimkibart: Participants in the two experimental groups receive afimkibart first by intravenous infusion and later by injection under the skin.
- Placebo: Participants in the placebo group receive placebo matched to intravenous afimkibart followed by placebo matched to the under-the-skin injection.
Study design
How the comparison works
This is a Phase 3, randomized, parallel-group study with two afimkibart groups and one placebo group. Participants remain in their assigned study group through the study’s induction and maintenance phases. Participants are assigned at random to parallel study groups, but the registry does not report the assignment ratio. The study is double-blind: the participant and investigator are masked to the assigned treatment. The control group receives placebo matched to both the intravenous and under-the-skin forms of afimkibart. The study includes one placebo group, but the registry does not state each participant’s probability of receiving placebo.
Reported activities
Procedures and tests
- Intravenous infusion of afimkibart or matching placebo.
- Under-the-skin injection of afimkibart or matching placebo.
- Endoscopic assessment using the Simple Endoscopic Score for Crohn’s Disease, including evaluation of ulcers, affected surface, and narrowing.
- Crohn’s Disease Activity Index assessment using symptoms and clinical information, including stool frequency, abdominal pain, complications, antidiarrheal use, abdominal mass, hematocrit, and body weight.
- Daily reporting of liquid or very soft stools and abdominal pain, summarized over seven-day periods.
- Self-reported bowel urgency assessment.
- Functional Assessment of Chronic Illness Therapy–Fatigue questionnaire.
- Inflammatory Bowel Disease Questionnaire covering bowel and systemic symptoms, emotional function, and social function.
- Patient Global Impression assessments of change and severity in Crohn’s disease symptoms.
- Investigator assessment of whether fistulas are draining or closed.
- Monitoring and grading of adverse events.
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 confirmed diagnosis of Crohn’s disease is required.
- Crohn’s disease must be moderately to severely active.
- Body weight must be at least 40 kilograms.
- At least one protocol-specified conventional or advanced Crohn’s disease therapy must have produced an inadequate response, lost response, or intolerance.
- People of childbearing potential must meet the protocol’s contraception requirements.
Possible reasons someone may not be able to join
- A current diagnosis of ulcerative, indeterminate, ischemic, infectious, radiation, or microscopic colitis is exclusionary.
- A history of at least three bowel resections, defined as more than two missing listed bowel segments, is exclusionary.
- Short gut or short bowel syndrome is exclusionary.
- An ileostomy, colostomy, or ileoanal pouch is exclusionary.
- Symptomatic bowel strictures, fulminant colitis, or toxic megacolon are exclusionary.
- An abdominal or perianal abscess is exclusionary.
- Pregnancy, breastfeeding, or intending to become pregnant during the study is exclusionary.
- Past or current gastrointestinal cancer or definite low- or high-grade colonic dysplasia is exclusionary.
- Screening evidence of C. difficile, cytomegalovirus, HIV, hepatitis B, or hepatitis C infection is exclusionary.
- Active tuberculosis, unsuccessfully treated latent tuberculosis, or inadequately treated tuberculosis is exclusionary.
- Receiving protocol-specified prohibited medicines, including any known exposure to anti-TL1A therapy, is exclusionary.
Important unknowns
What the record does not make clear
- The registry does not provide the number, frequency, length, or format of study visits.
- Outcome measurements are reported through Week 52, and adverse events are measured up to 70 weeks after baseline, but the total participation period is not stated.
- The registry lists two afimkibart groups and one placebo group but does not give the randomization ratio.
- The registry does not state which current Crohn’s disease treatments may continue during the study.
- The registry mentions protocol-specified prohibited medicines but does not provide the full list or any required stopping periods.
- The registry does not describe rescue treatment or what happens if Crohn’s disease worsens.
- Endoscopic outcomes are measured at Weeks 12 and 52 relative to baseline, but the registry does not provide the complete endoscopy schedule, preparation requirements, or sedation details.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not state whether participants receive compensation.
- The registry does not describe reimbursement or support for transportation, lodging, meals, or caregiving.
- The registry does not state whether any visits or assessments may be completed remotely.
- The registry does not describe access to afimkibart after study participation ends.
- The study is listed as recruiting overall, but some listed facilities are withdrawn and the registry does not confirm availability for a particular person or cohort.
Before contacting the site
Questions for the study team
- What is the chance of assignment to each afimkibart group or to placebo?
- What are the afimkibart and placebo dosing schedules, including the timing of the change from intravenous infusion to under-the-skin injections?
- How many study visits and endoscopies are required, and what preparation, sedation, or recovery time is involved?
- Which current Crohn’s disease treatments can continue, which are prohibited, and are washout periods required?
- What happens if symptoms worsen or Crohn’s disease complications develop during the study?
- Which study-related costs are covered, and are compensation or travel support available?
- Is the relevant cohort actively enrolling at my preferred site?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and what risks could come from changing or pausing my current treatment for screening or study participation?
- What approved treatment alternatives are reasonable for me to consider alongside learning more about this study?
- Do my disease location, prior bowel surgery, strictures, fistulas, abscess history, or other complications raise particular concerns?
- How should my usual gastroenterology care and monitoring be coordinated with the research team if I pursue screening?
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
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Study design and administration
- Organization
- Hoffmann-La Roche
- Organization class
- Industry
- Organization study ID
- GA45331
- Lead sponsor
- Hoffmann-La Roche
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Arm 1: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Interventions: Drug: Afimkibart
Experimental
Arm 2: Afimkibart
Participants will receive afimkibart IV followed by afimkibart SC injection.
Interventions: Drug: Afimkibart
Placebo Comparator
Arm 3: Placebo
Participants will receive placebo IV followed by placebo SC.
Interventions: Drug: Placebo
Interventions
Drug
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Drug
Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.
Eligibility
16 Years–80 Years
All
Not accepted
Inclusion criteria (5)
- Confirmed diagnosis of CDRegistry-derived · unreviewed
- Moderately to severely active CDRegistry-derived · unreviewed
- Bodyweight \>= 40 kilogram (kg)Registry-derived · unreviewed
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapyRegistry-derived · unreviewed
- Males and females of childbearing potential must meet protocol criteria for contraception requirementsRegistry-derived · unreviewed
Exclusion criteria (14)
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitisRegistry-derived · unreviewed
- Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)Registry-derived · unreviewed
- Diagnosis of short gut or short bowel syndromeRegistry-derived · unreviewed
- Presence of an ileostomy, colostomy or ileoanal pouchRegistry-derived · unreviewed
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolonRegistry-derived · unreviewed
- Presence of abdominal or perianal abscessRegistry-derived · unreviewed
- Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openingsRegistry-derived · unreviewed
- Current diagnosis or suspicion of primary sclerosing cholangitisRegistry-derived · unreviewed
- Pregnancy or breastfeeding, or intention of becoming pregnant during the studyRegistry-derived · unreviewed
- Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasiaRegistry-derived · unreviewed
- History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancerRegistry-derived · unreviewed
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screeningRegistry-derived · unreviewed
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TBRegistry-derived · unreviewed
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapyRegistry-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
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Time frame: At Week 52
Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Primary outcome
Percentage of Participants with Endoscopic Response
Time frame: At Week 52
Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Secondary outcome
Percentage of Participants with Clinical Remission
Time frame: At Week 12
Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Secondary outcome
Percentage of Participants with Endoscopic Response
Time frame: At Week 12
Percentage of participants achieving a decrease in SES-CD of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Secondary outcome
Percentage of Participants with Symptomatic Remission
Time frame: At Week 12
Percentage of participants with the daily number of liquid or very soft stools \<=2.8 and the average of daily abdominal pain scores in the past week \<=1, with neither being greater than baseline.
Secondary outcome
Percentage of Participants with Endoscopic Remission
Time frame: At Week 12
Percentage of participants with an SES-CD of 0 to 4 with a decrease from baseline \>=2 and no subscore \>1.
Secondary outcome
Percentage of Participants with Ulcer-free Endoscopy
Time frame: At Week 12
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Secondary outcome
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
Time frame: Baseline through Week 12
Daily average number of liquid or very soft stools over 7 days.
Secondary outcome
Average of Daily Abdominal Pain Scores in the Past Week (APS)
Time frame: Baseline through Week 12
The average daily rating of abdominal pain in the past 7 days. The pain is assessed on a scale of 0-3 with 0 indicating no pain and 3 indicating severe pain.
Secondary outcome
Percentage of Participants with Endoscopic Remission
Time frame: At Week 52
Percentage of participants with SES-CD=0 to 4 with decrease from baseline \>=2 and no subscore \>1 .
Secondary outcome
Percentage of Participants with Symptomatic Remission
Time frame: At Week 52
Percentage of participants with the daily number of liquid or very soft stools \<=2.8 and the average of daily abdominal pain scores in the past week \<=1, with neither being greater than baseline.
Secondary outcome
Percentage of Participants with Corticosteroid-free Clinical Remission
Time frame: At Week 52
Percentage of participants with clinical remission at Week 52 and no use of corticosteroids for CD at least 8 weeks prior to Week 52.
Secondary outcome
Maintenance of Clinical Remission
Time frame: At Weeks 12 and 52
Percentage of participants with clinical remission at both Weeks 12 and 52.
Secondary outcome
Maintenance of Endoscopic Response
Time frame: At Weeks 12 and 52
Percentage of participants with endoscopic response at both Weeks 12 and 52.
Secondary outcome
Percentage of Participants with Clinical Remission and Endoscopic Remission at Week 52
Time frame: At Week 52
Percentage of participants achieving a CDAI score of \<150 and SES-CD of 0 to 4 with a decrease from baseline \>=2 and no subscore \>1 at Week 52.
Secondary outcome
Percentage of Participants with Ulcer-free Endoscopy
Time frame: At Week 52
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Secondary outcome
Bowel Urgency
Time frame: Baseline through Week 12 and Week 52
Bowel urgency from baseline through week 12 and week 52. Bowel urgency is a single-item self-reported assessment of sudden or immediate need to have a bowel movement in the past 24 hours. The item response is reported on a 4-point Likert scale, from "None" to "Severe."
Secondary outcome
Fatigue
Time frame: Baseline to Week 12 and Week 52
Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12 and Week 52. FACIT-F is a 13-item self-reported assessment of fatigue. Each item response option indicates the degree to which a given statement describing the level or impact of fatigue applies in the past 7 days. Response options are graded on a 5-point Likert-type scale, from "Not at all" to "Very much."
Secondary outcome
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time frame: Baseline to Week 12 and Week 52
Change in IBDQ score from baseline to week 12 and 52. The IBDQ is a 32-item questionnaire that measures four domains: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). The total score ranges from 32-224, with a higher score indicating a better quality of life.
Secondary outcome
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Time frame: At Week 12
Percentage of participants achieving a CDAI score of \<150 at Week 12 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Secondary outcome
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Time frame: At Week 52
Percentage of participants achieving a CDAI score of \<150 at Week 52 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Secondary outcome
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Time frame: At Week 12
Percentage of participants achieving a decrease in SES-CD of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Secondary outcome
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Time frame: At Week 52
Percentage of participants achieving a decrease in SES-CD of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
Secondary outcome
Percentage of Participants with Clinical Response
Time frame: At Week 12
Percentage of participants with a decrease \>=100 in CDAI from baseline.
Secondary outcome
Percentage of Participants with Symptomatic Response
Time frame: At Week 12
Percentage of participants with a decrease \>=30% in both SF and APS, with neither being greater than baseline.
Secondary outcome
Overall Change in CD Symptoms
Time frame: Baseline to Weeks 2, 6, 12 and 52
Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6, 12 and 52. PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse".
Secondary outcome
Overall Severity in CD Symptoms
Time frame: Baseline to Weeks 2, 6, 12 and 52
Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6, 12 and 52. PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe".
Secondary outcome
Change in General Well-being
Time frame: Baseline through Week 52
The average daily rating of general well-being in the past 7 days. Well-being is assessed on a scale of 0-4 with 0 indicating generally well and 4 indicating terrible.
Secondary outcome
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to 70 Weeks after Baseline
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
Secondary outcome
Percentage of Participants with a Presence of Draining Fistulas
Time frame: Baseline through Week 12 and Week 52
Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining.
Recruiting locations in the United States
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
RecruitingDothan, Alabama, 36305, United States
Mayo Clinic Hospital
RecruitingPhoenix, Arizona, 85054, United States
Arizona Digestive Health, P.C (ADH)
RecruitingSun City, Arizona, 85351, United States
University of Arizona-CATS Research Center
RecruitingTucson, Arizona, 85724, United States
Valley View Internal Medicine
RecruitingGarden Grove, California, 92845-2006, United States
310 Clinical Research
RecruitingInglewood, California, 90301, United States
UCSD Medical Center
RecruitingLa Jolla, California, 92037-0897, United States
Gastro Care Associates
RecruitingLancaster, California, 93534, United States
Om Research LLC
RecruitingLancaster, California, 93534, United States
United Gastroenterologists
RecruitingLos Alamitos, California, 90720, United States
Acclaim Clinical Research, Inc.
RecruitingSan Diego, California, 92120, United States
Kaiser Permanente
RecruitingSan Francisco, California, 94115, United States
UCSF/Medical Center at Mount Zion
RecruitingSan Francisco, California, 94115, United States
Rocky Mountain Gastroenterology
RecruitingLittleton, Colorado, 80120, United States
Peak Gastroenterology Surgery Center
RecruitingLone Tree, Colorado, 80124, United States
Access Research Institute
RecruitingBrooksville, Florida, 34613, United States
Gastro Florida
RecruitingClearwater, Florida, 33756, United States
HealthMed Clinical Center Inc.
RecruitingCoral Gables, Florida, 33134, United States
Hi Tech and Global Research, LLC
RecruitingCoral Gables, Florida, 33134, United States
NeoClinical Research
RecruitingHialeah, Florida, 33016, United States
The Sister Life Research
RecruitingHialeah, Florida, 33013, United States
Clinical Research of Osceola, LLC
RecruitingKissimmee, Florida, 34741, United States
Florida Research Institute - Lakewood
RecruitingLakewood Rch, Florida, 34211, United States
LCC Medical Research Institute, LLC
RecruitingMiami, Florida, 33126, United States
Orlando Regional Healthcare
RecruitingOrlando, Florida, 32806, United States
Guardian Angel Research Center, LLC
RecruitingTampa, Florida, 33614, United States
Nodal Medical Center Research - NMC
RecruitingTampa, Florida, 33607, United States
University of South Florida School of Medicine Morsani Center for Advanced Health Care
RecruitingTampa, Florida, 33612, United States
Theia Clinical Research Centers, LLC
RecruitingTemple Terrace, Florida, 33617, United States
Cleveland Clinic Florida
RecruitingWeston, Florida, 33331, United States
Florida Medical Clinic - Orlando Health
RecruitingZephyrhills, Florida, 33542, United States
Atlanta Gastroenterology Associates
RecruitingAtlanta, Georgia, 30342, United States
Digestive Healthcare of Georgia
RecruitingAtlanta, Georgia, 30327, United States
Gastroenterology Associates of Central Georgia
RecruitingMacon, Georgia, 31201, United States
Grand Teton Research Group, PLLC
RecruitingIdaho Falls, Idaho, 83404, United States
Northwestern Memorial Hospital
RecruitingChicago, Illinois, 60611, United States
Illinois Gastroenterology Group-Glenview powered by GI Alliance
RecruitingGlenview, Illinois, 60026, United States
GI Alliance - Gurnee
RecruitingGurnee, Illinois, 60031, United States
Indiana University Health University Hospital
RecruitingIndianapolis, Indiana, 46202, United States
Gastroenterology Health Partners, PLLC
RecruitingNew Albany, Indiana, 47150, United States
Kansas Gastroenterology, LLC under Clinical Trials Network
RecruitingWichita, Kansas, 67226, United States
Tri-State Gastroenterology Associates
RecruitingCrestview Hills, Kentucky, 41017-3409, United States
Gastroenterology Health Partners, PLLC
RecruitingLouisville, Kentucky, 40218, United States
Boston University
RecruitingBoston, Massachusetts, 02118, United States
Brigham and Women's Hospital
RecruitingBoston, Massachusetts, 02115, United States
Michigan Center of Medical Research
RecruitingFarmington Hills, Michigan, 48334, United States
Gastroenterology Associates and Endoscopy Center of North Mississippi
RecruitingOxford, Mississippi, 38655, United States
Delta Gastroenterology & Endoscopy Center
RecruitingSouthaven, Mississippi, 38671, United States
Las Vegas Clinical Trials, LLC
RecruitingNorth Las Vegas, Nevada, 89030, United States
Lenox Hill Hospital
RecruitingNew York, New York, 10075, United States
Mount Sinai Hospital - IBD Clinical Center
RecruitingNew York, New York, 10029, United States
DiGiovanna Inst for Med Ed&Res
RecruitingNorth Massapequa, New York, 11758, United States
Queens Village Medical Care
RecruitingQueens Village, New York, 11428, United States
Mainstreet - Richmond Hill Clinic
RecruitingRichmond Hill, New York, 11418, United States
Gastroenterology Group Of Rochester, LLP
RecruitingRochester, New York, 14618, United States
University of Rochester Medical Center
RecruitingRochester, New York, 14642, United States
Atrium Health, Carolinas Healthcare System
RecruitingCharlotte, North Carolina, 28204, United States
Omega Research North Carolina, LLC
RecruitingFuquay-Varina, North Carolina, 27526, United States
Monroe Biomedical Research
RecruitingMonroe, North Carolina, 28112, United States
Dayton Gastroenterology, Inc.
RecruitingBeavercreek, Ohio, 45440, United States
Digestive Disease Consultants
RecruitingBrunswick, Ohio, 44212, United States
University of Cincinnati Hospital
RecruitingCincinnati, Ohio, 45267, United States
Cleveland Clinic Foundation
RecruitingCleveland, Ohio, 44195, United States
Ohio Gastroenterology Group
RecruitingColumbus, Ohio, 43202, United States
The Ohio State University Wexner Medical Center
RecruitingColumbus, Ohio, 43210, United States
Gastro Health- Liberty
RecruitingLiberty Township, Ohio, 45044, United States
Gastro Intestinal Research Institute of Northern Ohio
RecruitingWestlake, Ohio, 44145, United States
Central Sooner Research
RecruitingNorman, Oklahoma, 73071, United States
Penn State Milton S. Hershey Medical Center
RecruitingHershey, Pennsylvania, 17033, United States
Frontier Clinical Re search, LLC
RecruitingUniontown, Pennsylvania, 15401-9069, United States
University Gastroenterology
RecruitingProvidence, Rhode Island, 02904, United States
Medical University of South Carolina
RecruitingCharleston, South Carolina, 29425, United States
Gastroenterology Associates
RecruitingGreenville, South Carolina, 29607, United States
Gastro One
RecruitingGermantown, Tennessee, 38138, United States
Quality Medical Research
RecruitingNashville, Tennessee, 37211, United States
Texas Clinical Research Institute, LLC
RecruitingArlington, Texas, 76012, United States
Proactive El Paso,LLC
RecruitingEl Paso, Texas, 79902, United States
Amel Med LLC
RecruitingGeorgetown, Texas, 78628, United States
Cano Medical Center
RecruitingHarlingen, Texas, 78550, United States
Baylor College of Medicine
RecruitingHouston, Texas, 77030, United States
TDDC dba GI Alliance Research
RecruitingMansfield, Texas, 76063, United States
SMS Clinical Research, LLC
RecruitingMesquite, Texas, 75149, United States
Gastroenterology Research of America, LLC
RecruitingSan Antonio, Texas, 78229, United States
GI Alliance - Southlake
RecruitingSouthlake, Texas, 76092, United States
Baylor Scott and White Medical Center
RecruitingTemple, Texas, 76508, United States
Tyler Research Institute, LLC
RecruitingTyler, Texas, 75701, United States
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
RecruitingChesapeake, Virginia, 23320, United States
Emeritas Research Group
RecruitingLansdowne Town Center, Virginia, 20176, United States
Blue Ridge Medical Research - Gastroenterology Associates of Central Virginia
RecruitingLynchburg, Virginia, 24502, United States
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
RecruitingRoanoke, Virginia, 24014, United States
Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - Williamsburg
RecruitingWilliamsburg, Virginia, 23188, United States
The Vancouver Clinic
RecruitingVancouver, Washington, 98664, United States
This study also lists 279 locations outside the United States. They are not shown here.
Central study contacts
Reference Study ID Number: GA45331 https://forpatients.roche.com/ No attachments to email below.
Contact
888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Registry dates
- First posted
- Feb 11, 2025
- Primary completion
- Dec 31, 2028
- Overall completion
- Dec 31, 2033
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.