Moderately to Severely Active Crohn Disease
Obefazimod for Adults With Moderately to Severely Active Crohn’s Disease
This study is evaluating the efficacy and safety of once-daily obefazimod compared with placebo in adults with moderately to severely active Crohn’s disease after an inadequate response or intolerance to specified previous therapies.
Registry title: Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease
43 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- Obefazimod or Placebo
- Design
- Randomized · Quadruple
- Central study contact
- Study Director+33 (0) 1 53 83 09 63info@abivax.com
- Sponsor
- Abivax S.A.
Research question
How do obefazimod and placebo compare for efficacy and safety during induction and maintenance treatment, and for safety and tolerability during the extension phase, in this Crohn’s disease population?
Participant snapshot
Who the study is looking for
- The study is looking for adults aged 18 to 75.
- The study is looking for people with Crohn’s disease confirmed by endoscopy and histology reports.
- The study is looking for people whose Crohn’s disease meets specified moderate-to-severe activity thresholds based on symptom and endoscopy scores.
- The study is looking for people with a documented inadequate response, loss of response, or intolerance to at least one specified conventional or advanced Crohn’s disease therapy.
Participation overview
What participation may involve
Participation may involve once-daily obefazimod or matching placebo during a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase, with symptom, endoscopic, safety, and laboratory assessments. What participation may involve: - Take the assigned obefazimod dose or matching placebo once daily with food, ideally at the same time each morning. - Complete assessments used to calculate the Crohn’s Disease Activity Index and the two-item patient-reported outcome measure covering abdominal pain and stool frequency. - Undergo endoscopic assessment used for the Simple Endoscopic Score for Crohn’s Disease. - Have adverse events and specified blood laboratory measures monitored during the extension phase. The registry describes a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase.
Study interventions
What participants may receive or do
- Obefazimod: Obefazimod is the investigational drug. The registry describes 12.5 mg, 25 mg, and 50 mg groups, with the drug taken once daily with food, ideally at the same time each morning.
- Placebo: The matching placebo is taken once daily with food, ideally at the same time each morning, and serves as the study comparison.
Study design
How the comparison works
This Phase 2 treatment study assigns participants to parallel obefazimod dose groups or a placebo group and follows three treatment phases. Participants are assigned to study groups at random, but the registry does not report the assignment ratios. The study is quadruple-masked: participants, care providers, investigators, and outcome assessors are masked to treatment assignment. Results from three obefazimod dose groups are compared with results from a matching placebo group. A placebo group receives a matching placebo once daily with food; the registry does not state each participant’s probability of receiving placebo.
Reported activities
Procedures and tests
- Screening includes confirmation of Crohn’s disease through existing endoscopy and histology reports and assessment against required disease-activity scores.
- Endoscopic disease activity is measured with the Simple Endoscopic Score for Crohn’s Disease at Weeks 12 and 52.
- Crohn’s Disease Activity Index scores are assessed for change from baseline at Weeks 12 and 52.
- Patient-reported abdominal pain and soft or liquid stool frequency contribute to the PRO-2 assessments.
- Safety monitoring includes recording treatment-emergent and serious adverse events and events that lead to treatment discontinuation.
- Blood testing during the extension phase includes hematology, coagulation, liver, kidney, pancreatic, electrolyte, lipid, muscle, and cardiac-related laboratory measures.
- Screening criteria include laboratory thresholds for hemoglobin, neutrophils, platelets, kidney function, bilirubin, and liver enzymes.
- Screening criteria call for testing for specified infections, including stool pathogens, Clostridioides difficile, HIV, hepatitis B, hepatitis C, and tuberculosis.
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
- Participants must have been male or female at birth, be 18 to 75 years old, and be able to provide written informed consent before study procedures.
- Participants must be able and willing to attend study visits and follow study procedures.
- Crohn’s disease must be confirmed and documented by endoscopy and histology reports.
- Disease activity must meet a Crohn’s Disease Activity Index of 220 to 450 and the specified centrally read endoscopic score threshold for the disease location.
- Participants must have a documented inadequate response, loss of response, or intolerance to at least one listed therapy; failure of 5-aminosalicylic acid alone does not count.
- Participants with reproductive potential and certain partners must follow the protocol’s contraception requirements.
- Where required by the participating country or state, participants must be affiliated with a health insurance policy.
- Participants must be able and willing to follow usual public recommendations for sun protection.
Possible reasons someone may not be able to join
- Pregnancy or breastfeeding at screening, or an intention for the participant or a relevant partner to become pregnant during the study, is exclusionary.
- A current diagnosis of ulcerative colitis or indeterminate colitis is exclusionary.
- Crohn’s disease without involvement of the ileum or colon is exclusionary.
- An untreated active external or perianal fistula or abscess is exclusionary, subject to the registry’s exceptions for stable fistulas and adequately treated abscesses.
- A symptomatic bowel stricture or a stenosis that cannot be passed during endoscopy is exclusionary.
- Certain surgical histories or anatomy are exclusionary, including a current stoma or ileoanal pouch, extensive missing bowel segments or resections, recent bowel resection, or anticipated surgery.
- Prohibited Crohn’s disease therapies, previous natalizumab or another α4β1 integrin agonist, or failure of more than three advanced therapies or two advanced-therapy mechanisms are exclusionary.
- Specified active, recent, recurrent, or untreated infections—including HIV, hepatitis B or C, and active or untreated latent tuberculosis—are exclusionary, with limited stated exceptions.
- Screening laboratory results at or beyond the stated thresholds for blood counts, kidney function, bilirubin, or liver enzymes are exclusionary.
- Not meeting protocol-defined medication washout periods before the screening endoscopy 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.
- Four study groups are listed, but the randomization ratios and each participant’s probability of receiving placebo are not reported.
- The eligibility criteria refer to prohibited concomitant Crohn’s disease therapies, but the registry does not identify which current treatments may continue.
- Medication washout periods are required, but their durations and the affected medicines are only referenced as being in the study protocol.
- The registry does not describe rescue treatment or what happens if Crohn’s disease worsens.
- The record refers to a screening endoscopy and endoscopic outcomes at Weeks 12 and 52, but it does not give full preparation, sedation, biopsy, or scheduling details.
- The criteria mention health-insurance affiliation where locally required, but do not explain which study-related or routine-care costs are covered.
- The registry does not state whether participants are compensated.
- The registry does not describe reimbursement or support for transportation, lodging, meals, or caregiving.
- The registry does not state whether any visits or assessments can be completed remotely.
- The registry does not describe access to obefazimod after study participation ends.
- The study is listed as recruiting overall, but individual locations are variously listed as recruiting or not yet recruiting.
Before contacting the site
Questions for the study team
- What are the assignment ratios, and can treatment assignments change between the induction, maintenance, and extension phases?
- What is the complete visit schedule, including required endoscopies, blood draws, symptom reporting, and any remote visits?
- Which current Crohn’s disease medicines can continue, and which require a washout before the screening endoscopy?
- What treatment or clinical support is available if symptoms worsen during a washout period or after assignment to placebo?
- Which study-related expenses are covered, and are travel, lodging, parking, meals, or time reimbursed?
- Is the nearest listed site actively screening, and are all study groups open at that location?
- What happens after the 48-week extension phase, including follow-up and possible access to obefazimod?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and what risks could arise if my current treatment must be changed or paused for screening?
- Which approved treatment alternatives remain reasonable for me compared with considering this study?
- Do my disease location, prior surgeries, strictures, fistulas, or abscess history raise concerns under this study’s criteria?
- Are the study’s endoscopies, laboratory monitoring, and possible placebo exposure medically reasonable in the context of my current health?
- How should you and the research team coordinate medication changes, flare management, test results, and urgent care 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 study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies. The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.
Study design and administration
- Organization
- Abivax S.A.
- Organization class
- Industry
- Organization study ID
- ABX464-202
- Lead sponsor
- Abivax S.A.
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Obefazimod 50mg
Obefazimod 50mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Interventions: Drug: Obefazimod
Experimental
Obefazimod 25mg
Obefazimod 25mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Interventions: Drug: Obefazimod
Experimental
Obefazimod 12.5mg
Obefazimod 12.5mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Interventions: Drug: Obefazimod
Placebo Comparator
Placebo
Placebo given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD)
Interventions: Other: Placebo
Interventions
Drug
Obefazimod
Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning).
Other
Placebo
Matching placebo will be administered QD in fed condition (ideally at the same time in the morning).
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (8)
- Male or female (at birth) 18 to 75 years old and able to understand, sign, and date the written voluntary informed consent at the visit prior to any protocol-specified proceduresRegistry-derived · unreviewed
- Able and willing to comply with study visits and procedures as per protocol.Registry-derived · unreviewed
- Confirmed and documented diagnosis of CD based on endoscopy and histology reports.Registry-derived · unreviewed
- Moderately to severely active CD as defined by 220 ≤ CDAI ≤ 450 and SES-CD ≥ 6 for ileo-colonic or colonic disease or SES-CD ≥ 4 for isolated ileal disease (per central reading).Registry-derived · unreviewed
- Documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids (CS), immunosuppressants (IS), biologic or biosimilar therapies, or janus kinase (JAK) (note: failure to only 5-aminosalicylic acid \[5-ASA\] is not accepted)Registry-derived · unreviewed
- Women of childbearing potential (WOCBP) and male subjects with WOCBP partner must agree to comply with contraception requirements as stated in section 4.5 (contraception) of this protocol.Registry-derived · unreviewed
- Subject should be affiliated to a health insurance policy whenever required by a participating country or state.Registry-derived · unreviewed
- Subject is able and willing to comply with usual public recommendations for sun protection.Registry-derived · unreviewed
Exclusion criteria (47)
- WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study; or male subject with WOCBP partner who intends to be pregnant during the study.Registry-derived · unreviewed
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitisRegistry-derived · unreviewed
- CD without ileal and/or colonic involvementRegistry-derived · unreviewed
- Untreated active external or perianal fistula or abscess. Stable fistula without abscess and with minimal or low drainage may be enrolled. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before screening colonoscopy or 8 weeks before screening colonoscopy for intra-abdominal abscesses, if no additional surgery is anticipated.Registry-derived · unreviewed
- Symptomatic bowel stricture and/or stenosis not passable in endoscopyRegistry-derived · unreviewed
- Related to CD surgery:Registry-derived · unreviewed
- Current stoma or ileoanal pouchRegistry-derived · unreviewed
- More than 2 missing complete segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid and rectumRegistry-derived · unreviewed
- Combined previous small bowel resections \> 100 cmRegistry-derived · unreviewed
- Surgical bowel resection within the past 3 months prior to baselineRegistry-derived · unreviewed
- Any other manifestation that might require surgery while enrolled in the studyRegistry-derived · unreviewed
- Related to CD treatments:Registry-derived · unreviewed
- Subject who is currently treated with prohibited concomitant therapies for CD as described in the study protocolRegistry-derived · unreviewed
- Subject who has previously received natalizumab (or any other α4β1 integrin agonist)Registry-derived · unreviewed
- Subject who has failed more than three advanced therapies for the treatment of CD, or two different mechanisms of action for advanced therapies of CDRegistry-derived · unreviewed
- History of, or active, malignancy including nonmelanoma skin cancer (subjects with a 5-year disease-free survival are eligible)Registry-derived · unreviewed
- History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not)Registry-derived · unreviewed
- Subject with history of, or diagnosed with, the following during screening: primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosisRegistry-derived · unreviewed
- Serious illness requiring hospitalization (not related to CD) within 4 weeks prior to screeningRegistry-derived · unreviewed
- Subject with the following infectious conditions:Registry-derived · unreviewed
- Chronic or recurrent Grade 3 or Grade 4 infection within the last 2 months prior to screening or history of opportunistic infection while not on immunosuppressive therapyRegistry-derived · unreviewed
- Herpes zoster reactivation within the last 2 months prior to screeningRegistry-derived · unreviewed
- Active infection at screening or any major episode of infection that required hospitalization or treatment with IV antibiotics within 1 month of screening or during screening (fungal infection of nail beds is allowed)Registry-derived · unreviewed
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) that required treatment per local medical practice or positive test for Clostridioides difficile (C. difficile) toxin at screening.Registry-derived · unreviewed
- Subject with human immunodeficiency virus (HIV) infectionRegistry-derived · unreviewed
- Acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen \[HbsAg\] or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\], or detectable HBV DNA).Registry-derived · unreviewed
- Acute or chronic hepatitis C virus (HCV) infection as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence ≥ 1 year with no detectable HCV RNA \[assessed centrally\] are eligible)Registry-derived · unreviewed
- Active tuberculosis (TB) or untreated latent TB (For subjects with positive or intermediate QuantiFERON test)Registry-derived · unreviewed
- Subject with uncontrolled ischemic heart disease and/or a history of congestive heart failureRegistry-derived · unreviewed
- Subject with a known family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/ heart rate-corrected QT (QTc) intervalRegistry-derived · unreviewed
- Subject with a history of torsade de pointe (TdP)Registry-derived · unreviewed
- Acute or chronic clinically relevant pulmonary, hepatic, or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems.Registry-derived · unreviewed
- Subjects who received live vaccine within 3 months prior to screening and/or subject who is planning to receive such a vaccine during the study durationRegistry-derived · unreviewed
- Acute or chronic pancreatitisRegistry-derived · unreviewed
- Subject with the following hematological and biochemical laboratory parameters obtained during the screening period:Registry-derived · unreviewed
- Hemoglobin ≤ 8.0 g/dL1Registry-derived · unreviewed
- Absolute neutrophil count \< 750/mm3Registry-derived · unreviewed
- Platelets \< 100,000 /mm3Registry-derived · unreviewed
- eGFR \< 60 mL/min/1.73 m2Registry-derived · unreviewed
- Total serum bilirubin \> 1.5 x ULN (except if related to pre-existing and documented Gilbert syndrome)Registry-derived · unreviewed
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 x ULNRegistry-derived · unreviewed
- Subject who does not meet the washout period requirements prior to the screening endoscopy as described in the prohibited medication section of the study protocolRegistry-derived · unreviewed
- Use of any investigational or nonregistered product within 3 months or within 5 halflives preceding baseline, whichever is longer, and during the study.Registry-derived · unreviewed
- Subjects previously treated with obefazimod or with a known hypersensitivity to the active substance or to any of the excipientsRegistry-derived · unreviewed
- Illicit drug or alcohol abuse or dependenceRegistry-derived · unreviewed
- Subject who is committed to an institution by virtue of an order issued either by the judicial or the administrative authoritiesRegistry-derived · unreviewed
- Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocolRegistry-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
Induction and maintenance Phase Efficacy- Crohn's Disease Activity Index (CDAI)
Time frame: Week 12 and week 52
Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 12 and Week 52 The CDAI total score ranges from 0 to over 600. Higher scores mean a worse outcome.
Primary outcome
Maintenance Phase Efficacy - Simple Endoscopic Score for Crohn's disease (SES-CD)
Time frame: Week 52
Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 52 The SES-CD is an endoscopic grading system that consists of a composite score based on 4 components: the size of mucosal ulcers, the extent of the ulcerated surface, the endoscopic extension, and the presence of stenosis (26). Each of the 4 SES-CD components are assessed in the 5 segments of the ileum and colon: ileum, right, transverse, left, and rectum. The SES-CD is the sum of the individual scores of each of the components across the 5 segments. The total score ranges from 0 to 60. Higher scores mean a worse outcome
Primary outcome
Maintenance Phase Efficacy - Endoscopic response
Time frame: Week 52
Proportion of subjects with endoscopic response at Week 52
Primary outcome
Maintenance Phase Efficacy - SES-CD ulcer subscore > 1
Time frame: Week 52
Proportion of subjects with no SES-CD ulcer subscore \> 1 in at least one segment at Week 52
Primary outcome
Maintenance Phase Efficacy - CDAI clinical remission
Time frame: Week 52
Proportion of subjects with CDAI clinical remission at Week 52 Proportion of subjects with sustained CDAI clinical remission at Week 52
Primary outcome
Maintenance Phase Efficacy - PRO-2 clinical remission
Time frame: Week 52
Proportion of subjects with patient reported outcome (PRO)-2 clinical remission at Week 52
Primary outcome
Maintenance Phase Efficacy - CDAI clinical response
Time frame: Week 52
Proportion of subjects with CDAI clinical response (CDAI decrease from baseline ≥ 100 points) at Week 52
Primary outcome
Maintenance Phase Efficacy - PRO-2 clinical response
Time frame: Week 52
Proportion of subjects with PRO-2 clinical response (≥ 30% decrease in average daily PRO-2 score (AP + SF) and both no higher than baseline) at Week 52
Primary outcome
Maintenance Phase Efficacy - CDAI clinical response and endoscopic response
Time frame: Week 52
Proportion of subjects with CDAI clinical response and endoscopic response at Week 52
Primary outcome
Maintenance Phase Efficacy - endoscopic remission
Time frame: Week 52
Proportion of subjects with endoscopic remission at Week 52
Primary outcome
Extension Phase Safety- Adverse events
Time frame: Weeks 64, 76, 88,100 and EOS
Incidence of all treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and causally related TEAEs/SAEs Incidence of adverse events (AEs) leading to discontinuation
Primary outcome
Extension Phase Safety - Hematology and coagulation
Time frame: Weeks 64, 76, 88,100 and EOS
Number of patients with clinically-significant abnormal laboratory parameters. Hematology: Hematocrit, hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, platelet count, red blood cells; white blood cells Coagulation: International normalized ratio, activated partial thromboplastin time, fibrinogen, prothrombin time
Primary outcome
Extension Phase Safety - Biochemistry
Time frame: Weeks 64, 76, 88,100 and EOS
Number of patients with clinically-significant abnormal laboratory parameters. Albumin, total protein, aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin, gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH), lipase, amylase, creatinine, creatinine clearance, urea, chloride, bicarbonate, sodium, potassium, calcium, phosphate, uric acid, glucose, total cholesterol, LDL cholesterol (direct), HDL cholesterol, triglycerides, creatine phosphokinase (CPK), high sensitivity troponin I and T, N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Secondary outcome
Induction Phase Efficacy - SES-CD
Time frame: Week 12
Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 12
Secondary outcome
Induction Phase Efficacy - Endoscopic response
Time frame: Week 12
Proportion of subjects with endoscopic response at Week 12
Secondary outcome
Induction Phase Efficacy-SES-CD ulcer subscore > 1
Time frame: Week 12
Proportion of subjects with no SES-CD ulcer subscore \> 1 in at least one segment at Week 12
Secondary outcome
Induction Phase Efficacy-CDAI clinical remission
Time frame: Week 12
Proportion of subjects with Crohn's Disease Activity Index (CDAI) clinical remission (CDAI score \< 150) at Week 12 The total CDAI score ranges from 0 to over 600. Higher scores mean a worse outcome
Secondary outcome
Induction Phase Efficacy-PRO-2 clinical remission
Time frame: Week 12
Proportion of subjects with patient reported outcome (PRO)-2 clinical remission (Combination of average daily abdominal pain score ≤ 1.0 plus average daily soft or liquid stool frequency ≤ 2.8 and both no higher than baseline) at Week 12
Secondary outcome
Induction Phase Efficacy-CDAI clinical response
Time frame: Week 12
Proportion of subjects with CDAI clinical response (CDAI decrease from baseline ≥ 100 points) at Week 12 The total CDAI score ranges from 0 to over 600. Higher scores mean a worse outcome
Secondary outcome
Induction Phase Efficacy-PRO-2 clinical response
Time frame: Week 12
Proportion of subjects with PRO-2 clinical response at Week 12
Secondary outcome
Induction Phase Efficacy-CDAI clinical response and endoscopic response
Time frame: Week 12
Proportion of subjects with CDAI clinical response (CDAI decrease from baseline ≥ 100 points) and endoscopic response (Simple Endoscopic Score for Crohn's disease (SES-CD) decrease from baseline ≥ 50%) at Week 12 The total CDAI score ranges from 0 to over 600. Higher scores mean a worse outcome The total SES-CD score ranges from 0 to 60. Higher scores mean a worse outcome.
Secondary outcome
Induction Phase Efficacy - endoscopic remission
Time frame: Week 12
Proportion of subjects with endoscopic remission at Week 12
Recruiting locations in the United States
IMC Gulf Coast Gastroenterology, PC
Not Yet RecruitingFairhope, Alabama, 36532, United States
Nathaniel Winstead, MD
Scottsdale Gastroenterology Specialists
Not Yet RecruitingScottsdale, Arizona, 85260, United States
S. Jaffrey Kazi, MD
GI Alliance -Gurnee
RecruitingSun City, Arizona, 85351, United States
Chirag Trivedi, MD
Hoag Hospital
Not Yet RecruitingIrvine, California, 92618, United States
Caroline Hwang, MD
United Medical Doctors
RecruitingMurrieta, California, 92563, United States
John Hong, MD
Peak Gastroenterology Associates
RecruitingColorado Springs, Colorado, 80907, United States
Bhaktasharan Patel, MD
Clinical Research Of Brandon, LLC
RecruitingBrandon, Florida, 33511, United States
German Alvarez, MD
West Central Gastroenterology d/b/a Gastro Florida
RecruitingClearwater, Florida, 33762, United States
Tejinder Glamour, MD
Auzmer Research
RecruitingLakeland, Florida, 33813, United States
Niaz Ausaf, MD
Research Associates of South Florida, LLC
RecruitingMiami, Florida, 33134, United States
Alexander Veloso, MD
Wellness Clinical Research
Not Yet RecruitingMiami Lakes, Florida, 33016, United States
Lucky Flores, MD
Advanced Research Institute, Inc.
RecruitingNew Port Richey, Florida, 34653, United States
Curtis Freedland, MD
Sarkis Clinical Trials - Parent
RecruitingOcala, Florida, 34474, United States
Vishnu Reddy, MD
Orlando Health, Inc.
RecruitingOrlando, Florida, 32806, United States
Udayakumar Navaneethan, MD
GCP Clinical Research, LLC
RecruitingTampa, Florida, 33609, United States
Alan Weintraub, MD
Theia Clinical Research Centers, LLC
RecruitingTemple Terrace, Florida, 33617, United States
Zubair Farooqui, MD
Northwestern University
RecruitingEvanston, Illinois, 60208, United States
Emanelle Bellaguarda, MD
University of Iowa Health Care
Not Yet RecruitingIowa City, Iowa, 52242, United States
Steven Polyak, MD
Lucida Clinical Trials, LLC
RecruitingNew Bedford, Massachusetts, 02740, United States
Jason Reich, MD
University of Massachusetts, Worcester
Not Yet RecruitingWorcester, Massachusetts, 01655, United States
Abbas Rupawala, MD
Henry Ford Columbus Center
RecruitingDetroit, Michigan, 48202, United States
Najwa El-Nachef, MD
Dartmouth-Hitchcock Medical Center
Not Yet RecruitingLebanon, New Hampshire, 03756, United States
Corey Siegel, MD
OSU Inflammatory Bowel Disease Center
Not Yet RecruitingHilliard, Ohio, 43026, United States
Madalina Butnariu, MD
Susquehanna Research Group, LLC
Not Yet RecruitingHarrisburg, Pennsylvania, 17110, United States
Adnan Ahmad, MD
UPMC
Not Yet RecruitingPittsburgh, Pennsylvania, 15213, United States
Marc Schwartz, MD
Frontier Clinical Research, LLC
RecruitingUniontown, Pennsylvania, 15401, United States
Marc Happe, MD
Rapid City Medical Center, LLC
RecruitingRapid City, South Dakota, 57701, United States
Blake Jones, MD
Vanderbilt University Medical Center
Not Yet RecruitingNashville, Tennessee, 37212, United States
Audrey Bennett, MD
Central Texas Clinical Research, LLC
Not Yet RecruitingAustin, Texas, 78705, United States
Cynthia Brinson, MD
Inquest Clinical Research
Not Yet RecruitingBaytown, Texas, 77521, United States
Haider Afzal, MD
Novel Research, LLC
RecruitingBellaire, Texas, 77401, United States
Moazzam Sana, MD
GI Alliance
RecruitingCedar Park, Texas, 78613, United States
Ryan Cho, MD
Baylor University Hospital
RecruitingDallas, Texas, 75246, United States
Themistocles Dassopoulos, MD
GI Alliance - Garland
Not Yet RecruitingGarland, Texas, 75044, United States
Harry Sarles, MD
Texas Digestive Specialists
RecruitingHarlingen, Texas, 78550, United States
Nolan Perez, MD
Houston Methodist Hospital
Not Yet RecruitingHouston, Texas, 77030, United States
Bincy Abraham, MD
GI Alliance - Gurnee
Not Yet RecruitingMansfield, Texas, 76063, United States
Moustafa Youssef, MD
Southern Star Research Institute, LLC
Not Yet RecruitingSan Antonio, Texas, 78229, United States
Jeff Bullock, MD
Tyler Research Institute, LLC
RecruitingTyler, Texas, 75701, United States
George Aaron DuVall, MD
University of Utah
RecruitingSalt Lake City, Utah, 84108, United States
John Valentine, MD
Richmond VA Medical Center
Not Yet RecruitingRichmond, Virginia, 23249, United States
William Pandak, MD
Gastroenterology Consultants of Southwest Virginia.
RecruitingRoanoke, Virginia, 24014, United States
Nirish Shah, MD
University of Washington
Not Yet RecruitingSeattle, Washington, 98195, United States
Scott Lee, MD
This study also lists 106 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Jun 13, 2024
- Primary completion
- Dec 2026
- Overall completion
- Apr 2028
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.