Crohn's Disease
Phase 3 duvakitug induction study for active Crohn’s disease
This Phase 3 study is investigating the efficacy and safety of injected duvakitug, compared with placebo in part of the study, in people with moderately to severely active Crohn’s disease.
Registry title: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
94 recruiting U.S. sites ↓Study at a glance
- Age
- 16 Years–80 Years
- Treatment
- Duvakitug or Placebo
- Design
- Randomized · Quadruple
- Central study contact
- Trial Transparency email recommended (Toll free for US & Canada)800-633-1610 ext. option 6Contact-US@sanofi.com
- Sponsor
- Sanofi
Research question
Can duvakitug induce improvement in moderately to severely active Crohn’s disease over 12 weeks, and what safety findings occur during treatment and follow-up?
Participant snapshot
Who the study is looking for
- The study is looking for people with moderately to severely active Crohn’s disease diagnosed at least three months before baseline.
- Most participants must be 18 to 80 years old at screening.
- Where locally permitted, people aged 16 to under 18 may be considered if they meet the Tanner Stage 5 development requirement.
- The study is looking for people whose Crohn’s disease did not respond adequately, stopped responding, or was not tolerated with conventional or advanced therapies.
Participation overview
What participation may involve
Participation may include screening, up to 12 weeks in an induction sub-study, possible entry into a further 12-week extended induction for non-responders, and follow-up for people who do not enter the separate maintenance study. What participation may involve: - Participants may receive subcutaneous injections of duvakitug or placebo, depending on their sub-study and assigned arm. - The study assesses Crohn’s disease symptoms and signs using the Crohn’s Disease Activity Index and patient-reported stool frequency and abdominal pain. - Endoscopic disease activity is assessed with the Simple Endoscopic Score for Crohn’s Disease using central reading. - The study also evaluates fatigue, quality of life, bowel urgency, hospitalizations, adverse events, duvakitug serum concentrations, and anti-drug antibodies. The registry states that total study duration may be up to 35 weeks, including up to five weeks of screening, 12 weeks in an initial induction sub-study, a possible 12-week extended induction, and a 45-day follow-up for participants who do not enter the maintenance study. For participants who continue into the separate maintenance study, the registry reports up to eight scheduled visits for Sub-Study 1 or 2 and up to 15 visits for those who also enter Sub-Study 3.
Study interventions
What participants may receive or do
- Duvakitug: Duvakitug, also called SAR447189, is given as a subcutaneous injection. The study includes two duvakitug dose groups, but the doses are not stated in the registry record.
- Placebo: The placebo is given as a subcutaneous injection and is used as the comparison intervention in the placebo arm.
Study design
How the comparison works
This multinational, multicenter Phase 3 induction study contains three sub-studies: a single-arm open-label feeder induction, a pivotal induction study, and an extended induction for non-responders. The registry describes the overall design as parallel, randomized, and placebo-controlled. The registry lists randomized allocation for the study, while Sub-Study 1 is specifically described as single-arm and open-label. The design module reports quadruple masking of participants, care providers, investigators, and outcome assessors. Sub-Study 1 is separately described as open-label. The listed arms include two duvakitug dose groups and one placebo comparison group, all using subcutaneous injections. A placebo injection is used in a comparison arm, but the registry does not report the allocation ratio or an individual participant’s probability of receiving placebo.
Reported activities
Procedures and tests
- Subcutaneous study injections
- Crohn’s Disease Activity Index assessment using symptoms, signs, and a laboratory test
- Endoscopic assessment using the Simple Endoscopic Score for Crohn’s Disease with central reading
- Patient reporting of daily stool frequency and abdominal pain
- Seven-item Patient-Reported Outcomes Measurement Information System fatigue questionnaire
- Thirty-two-item Inflammatory Bowel Disease Questionnaire covering bowel symptoms, systemic symptoms, emotional function, and social function
- Bowel-urgency rating on an 11-point numeric scale
- Monitoring of treatment-emergent adverse events through 45 days after the last dose
- Testing of serum duvakitug concentrations
- Testing for treatment-emergent anti-drug antibodies against duvakitug
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 generally must be 18 through 80 years old at screening. Where local rules permit, participants aged 16 to under 18 must meet the Tanner Stage 5 development requirement.
- A diagnosis of moderately to severely active Crohn’s disease must have been confirmed at least three months before baseline.
- Participants must have had an inadequate response, loss of response, or intolerance to conventional or advanced therapies.
Possible reasons someone may not be able to join
- People with ulcerative colitis or indeterminate colitis are excluded.
- People missing two entire listed intestinal segments are excluded.
- Prior or current high-grade gastrointestinal dysplasia is an exclusion.
- Participants taking conventional therapy must be on stable doses before baseline.
- People receiving medications or therapies prohibited by the protocol are excluded.
- Previous exposure to an investigational therapy targeting TL1A is an exclusion.
Important unknowns
What the record does not make clear
- The registry gives maximum visit counts for participants continuing into the maintenance study but does not provide the timing or visit count for every possible pathway.
- The study lists two duvakitug arms and one placebo arm but does not report the randomization ratio.
- The criteria refer to stable conventional therapy and prohibited treatments but do not identify which Crohn’s disease medicines may continue.
- The registry does not state washout periods for prior medicines or therapies.
- The registry does not describe rescue treatment if Crohn’s disease worsens during induction.
- Endoscopic outcomes are reported, but the complete endoscopy schedule and preparation requirements are not stated.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report whether transportation, lodging, or other travel support is available.
- The record describes possible entry into a separate maintenance study but does not explain access to duvakitug after study participation ends.
- The study and listed locations are marked recruiting, but the record does not confirm that a particular sub-study or participant category remains open at any specific site.
Before contacting the site
Questions for the study team
- Which of the three sub-studies would I be screened for, and what determines that pathway?
- What are the duvakitug doses and injection schedule in each applicable arm?
- What is the randomization ratio, and what is the chance of receiving placebo in the relevant sub-study?
- What is the complete visit, endoscopy, laboratory-test, and injection schedule for my possible pathway?
- Which current or recent Crohn’s disease treatments must be stable, stopped, or washed out?
- What happens if Crohn’s disease worsens or does not respond during the initial 12 weeks?
- Which expenses are covered, and are compensation or travel assistance available?
- If I complete induction, what are the options for entering the maintenance study or accessing treatment afterward?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and what could happen if the protocol requires changes to my current treatment?
- What approved treatment alternatives are available for me outside this study?
- How would placebo exposure or delayed response fit with my current disease activity and risk of worsening?
- Are the study’s planned endoscopic, symptom, and laboratory assessments appropriate in my clinical situation?
- How should my regular gastroenterology care and urgent-care plan be coordinated with the research team?
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 is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). * 12-week Sub-Study 3 (Extended Induction for non-responders). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
Study design and administration
- Organization
- Sanofi
- Organization class
- Industry
- Organization study ID
- EFC18326
- Lead sponsor
- Sanofi
- 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
- Child, Adult, Older Adult
Study arms
Experimental
Duvakitug Dose 1
Subcutaneous (SC) Injection as per protocol
Interventions: Drug: Duvakitug
Experimental
Duvakitug Dose 2
SC injection as per protocol
Interventions: Drug: Duvakitug
Placebo Comparator
Placebo
SC injection as per protocol
Interventions: Drug: Placebo
Interventions
Drug
Duvakitug
Pharmaceutical form:Injection solution Route of administration:SC injection
Drug
Placebo
Pharmaceutical form:Injection solution Route of administration:SC injection
Eligibility
16 Years–80 Years
All
Not accepted
Inclusion criteria (3)
- Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \<18 years of age who meet the definition of Tanner Stage 5 for developmentRegistry-derived · unreviewed
- Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baselineRegistry-derived · unreviewed
- Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)Registry-derived · unreviewed
Exclusion criteria (7)
- Participants with Ulcerative Colitis (UC) or indeterminate colitisRegistry-derived · unreviewed
- Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectumRegistry-derived · unreviewed
- Prior or current high-grade gastrointestinal (GI) dysplasiaRegistry-derived · unreviewed
- Participants on treatment with but not on stable doses of conventional therapy prior to baselineRegistry-derived · unreviewed
- Participants receiving prohibited medications or therapiesRegistry-derived · unreviewed
- Participants with previous exposure to anti-TL1A investigational therapyRegistry-derived · unreviewed
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.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
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12
Time frame: Week 12
Clinical Remission by CDAI: CDAI score \<150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Primary outcome
Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12
Time frame: Week 12
Endoscopic Response is defined as decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.
Primary outcome
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12
Time frame: Week 12
Clinical Remission per PRO-2: average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average daily abdominal pain (AP) ≤1 and not worse than the Baseline.
Primary outcome
Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12
Time frame: Week 12
Endoscopic Response is defined as decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading. The SES-CD is a standardized method for evaluating disease activity. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores represent more severe disease.
Secondary outcome
Sub-Study 2: Proportion of participants achieving CDAI clinical response at Week 12
Time frame: Week 12
CDAI clinical response is defined as decrease in CDAI score of 100 points or more from baseline.
Secondary outcome
Sub-study 2: Proportion of participants achieving CDAI clinical response and endoscopic response (SES-CD) at Week 12
Time frame: Week 12
CDAI clinical response is defined as decrease in CDAI score of 100 points or more from baseline. Endoscopic Response by SES-CD was defined as a decrease in SES-CD ≥50% from baseline (or a decrease of at least 2 points for participants with a baseline score of 4 or more, and isolated ileal disease) based on central reading.
Secondary outcome
Sub-study 2: Proportion of participants achieving endoscopic SES-CD remission at Week 12
Time frame: Week 12
Endoscopic Remission by SES-CD is defined as SES-DC ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score \>1 point from baseline
Secondary outcome
Sub-study 2: US/FDA: Proportion of participants achieving clinical remission per PRO-2 at Week 12
Time frame: Week 12
Clinical Remission per PRO-2: average daily SF ≤3 and not worse than the Baseline, and average daily AP ≤1 and not worse than the Baseline.
Secondary outcome
Sub-study 2: EU/EMA: Proportion of participants achievingclinical remission per CDAI at Week 12
Time frame: Week 12
Clinical Remission by CDAI: CDAI score \<150. The CDAI is a measure of disease activity based on symptoms, signs, and a laboratory test. Scores on the CDAI scale range from 0 to 600, with scores below 150 indicating relative disease quiescence (remission), 150 to 219 indicating mild disease activity, 220 to 450 indicating moderate activity, and scores exceeding 450 indicating severe disease.
Secondary outcome
Sub-study 2: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at baseline) at Week 12
Time frame: Week 12
Ulcer-free endoscopy: SES-CD ulcerated surface sub-score of 0 in participants with SES-CD ulcerated surface sub-score ≥1 at Baseline, as scored by a central reader.
Secondary outcome
Sub-study 2: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a T-score at Week 12
Time frame: Baseline, Week 12
The PROMIS Fatigue Short Form 7a uses a 5-point Likert scale for each of its 7 items, resulting in a raw score range of 7 to 35. This raw score is then converted into a T-score, with a mean of 50 and a standard deviation of 10, based on US national norms. Higher T-scores indicate greater fatigue.
Secondary outcome
Sub-study 2: Proportion of participants achieving CDAI clinicalresponse at Week 4
Time frame: Week 4
CDAI clinical response is defined as decrease in CDAI score of 100 points or more from baseline.
Secondary outcome
Sub-study 2: US/FDA: Proportion of participants achievingcorticosteroid free remission (in the subset ofparticipants with corticosteroids at baseline) perCDAI at Week 12
Time frame: Week 12
Corticosteroid free remission per CDAI: proportion of participants who discontinue corticosteroid use for CD and achieve clinical remission per CDAI (CDAI score \<150) at Week 12, in participants taking corticosteroids for CD at Baseline.
Secondary outcome
Sub-study 2: EU/EMA: Proportion of participants achievingcorticosteroid free remission per PRO-2 (in thesubset of participants with corticosteroids atbaseline) at Week 12
Time frame: Week 12
Corticosteroid free remission by PRO-2: proportion of participants who discontinue corticosteroid use for CD and achieve clinical remission per PRO-2 (average daily SF ≤3 and not worse than the baseline, and average daily AP ≤1 and not worse than the baseline) at Week 12, in participants taking corticosteroids for CD at Baseline.
Secondary outcome
Sub-study 2: Proportion of participants achieving CDAI clinical remission and endoscopic remission (SES-CD) at Week 12
Time frame: Week 12
Clinical Remission by CDAI: CDAI score \<150. Endoscopic Remission: SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD sub score \>1 point from baseline.
Secondary outcome
Sub-study 2: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 12
Time frame: Baseline, Week 12
IBDQ instrument consist of 32 items exploring 4 dimensions: "bowel symptoms" (10 items), "systemic symptoms" (5 items), "emotional function" (12 items) and "social function" (5 items). The total IBDQ total score ranges from 32 to 224 with higher score indicating better quality of life.
Secondary outcome
Sub-study 2: Proportion of participants with no bowel urgency byNumeric Rating Scale (NRS) at Week 12
Time frame: Week 12
The NRS for bowel urgency is a well-defined and reliable instrument to evaluate treatment benefits in participants with CD. The NRS for bowel urgency measures the severity of bowel urgency-the sudden or immediate need to have a bowel movement-experienced in the past 24 hours. This tool utilizes an 11-point scale for evaluation, from 0 (no urgency) to 10 (worst possible urgency).
Secondary outcome
Sub-study 2: Proportion of participants with CD-related hospitalizations by Week 12
Time frame: Baseline through Week 12
Secondary outcome
Sub-study 2: Number of participants with any Treatment Emergent Adverse Events (TEAEs), TEAE of special interest (TEAESIs), TE serious adverse event (TESAEs), and TEAEs leading to permanent study intervention discontinuation
Time frame: Baseline through 45 days after the last dose
Secondary outcome
Sub-study 2: Serum concentrations of duvakitug
Time frame: Baseline to Week 12
Secondary outcome
Sub-study 2: Incidence of treatment-emergent Anti-drug Antibodies (ADA) against duvakitug
Time frame: Baseline to Week 12
Recruiting locations in the United States
Onyx Clinical Research - Site Number: 8400021
RecruitingPeoria, Arizona, 85381, United States
One of a Kind Clinical Research Center LLC-Site Number: 8400061
RecruitingScottsdale, Arizona, 85258, United States
Del Sol Research Management, LLC-Site Number: 8400012
RecruitingTucson, Arizona, 85715, United States
Preferred Research Partners: 8400018
RecruitingLittle Rock, Arkansas, 72211, United States
Kagoshima IBD Gastroenterology Clinic - Site Number: 8400008
RecruitingCanoga Park, California, 91304, United States
Southern California GI & Liver Centers-Site Number: 8400062
RecruitingCoronado, California, 92118-1408, United States
GMC Clinical Research, LLC-Site Number: 8400113
RecruitingFolsom, California, 95630, United States
TLC Clinical Research Inc.: 8400030
RecruitingLos Angeles, California, 90048, United States
United Medical Doctors CA-Site Number: 8400044
RecruitingMurrieta, California, 92563, United States
Prospective Research Innovations Inc.: 8400017
RecruitingRancho Cucamonga, California, 91730, United States
UC Davis Health System-Site Number: 8400071
RecruitingSacramento, California, 95817, United States
Clinical Applications Laboratories Inc-Site Number: 8400056
RecruitingSan Diego, California, 92103, United States
Medical Associates Research Group-Site Number: 8400063
RecruitingSan Diego, California, 92123, United States
Valiance Clinical Research - Tarzana: 8400023
RecruitingTarzana, California, 91356, United States
Clinical Trials Management Services-Site Number: 8400047
RecruitingThousand Oaks, California, 91360, United States
Amicis Research Center-Valencia-Site Number: 8400064
RecruitingValencia, California, 91355, United States
Om Research, LLC - Victorville - Site Number: 8400022
RecruitingVictorville, California, 92395, United States
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
RecruitingColorado Springs, Colorado, 80907, United States
Gastroenterology of the Rockies - Denver-Site Number: 8400122
RecruitingDenver, Colorado, 80218, United States
Novum Research, LLC-Site Number: 8400003
RecruitingClermont, Florida, 34711, United States
Precision Clinical Research: 8400059
RecruitingCoral Springs, Florida, 33065, United States
Sarkis Clinical Trials-Ocala-Site Number: 8400048
RecruitingGainesville, Florida, 32607, United States
Clinical Research of Osceola-Site Number: 8400013
RecruitingKissimmee, Florida, 34741, United States
Bio Research Partner-Site Number: 8400053
RecruitingMiami, Florida, 33155, United States
Columbus Clinical Services LLc-Site Number: 8400038
RecruitingMiami, Florida, 33125, United States
Correa Research Center-Site Number: 8400010
RecruitingMiami, Florida, 33186, United States
Medical Professional Clinical Research Center-Site Number: 8400119
RecruitingMiami, Florida, 33165, United States
Paradisus Med Research-Site Number: 8400036
RecruitingMiami, Florida, 33185, United States
Regis Clinical Research, LLC-Site Number: 8400041
RecruitingMiami, Florida, 33126, United States
Orlando Health, Inc.-Site Number: 8400084
RecruitingOrlando, Florida, 32806, United States
Tropical Clinical Trials-Site Number: 8400082
RecruitingPalmetto Bay, Florida, 33176, United States
NMC Research LLC - Site Number: 8400033
RecruitingTampa, Florida, 33607, United States
Atlanta Gastroenterology Associates-Site Number: 8400109
RecruitingAtlanta, Georgia, 30342, United States
M3 Wake Research - Atlanta: 8400028
RecruitingSandy Springs, Georgia, 30328, United States
EBGS Clinical Research Center, LLC-Site Number 8400037
RecruitingSnellville, Georgia, 30078, United States
Grand Teton Research Group, PLLC-Site Number: 8400127
RecruitingIdaho Falls, Idaho, 83404, United States
Midwest Digestive Health and Nutrition-Site Number: 8400136
RecruitingDes Plaines, Illinois, 60016, United States
GI Alliance - Glenview - Site Number: 8400068
RecruitingGlenview, Illinois, 60031, United States
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee - Site Number: 8400049
RecruitingGurnee, Illinois, 60031, United States
Gastroenterology Health Partners, PLLC - Site Number: 8400100
RecruitingNew Albany, Indiana, 47150, United States
Cedar Valley Digestive Health Center-Site Number: 8400096
RecruitingWaterloo, Iowa, 50701, United States
GI Alliance - Baton Rouge - Site Number: 8400129
RecruitingBaton Rouge, Louisiana, 70809, United States
Tandem Intermediate, LLC - Houma-Site Number: 8400034
RecruitingHouma, Louisiana, 70360, United States
Gastro Group-Site Number: 8400128
RecruitingMandeville, Louisiana, 70471, United States
Tandem Clinical Research - Marrero-Site Number: 8400002
RecruitingMarrero, Louisiana, 70072, United States
GI Alliance - Metairie-Site Number: 8400124
RecruitingMetairie, Louisiana, 70006, United States
Delta Research Partners-Site Number: 8400087
RecruitingMonroe, Louisiana, 71291, United States
Care Access - New Iberia-Site Number: 8400031
RecruitingNew Iberia, Louisiana, 70560, United States
Mid-Atlantic GI Research, LLC - Site Number: 8400106
RecruitingGreenbelt, Maryland, 20770, United States
UMass Memorial Medical Center-Site Number: 8400121
RecruitingWorcester, Massachusetts, 01655, United States
Gastroenterology Associates of Western Michigan - Site Number: 8400060
RecruitingWyoming, Michigan, 49519, United States
Allied Health Clinical Research Organization, LLC - Jackson-Site Number: 8400007
RecruitingJackson, Mississippi, 08527, United States
Gateway Gastroenterology: 8400097
RecruitingChesterfield, Missouri, 63017, United States
BVL Clinical Research: 8400005
RecruitingLiberty, Missouri, 64068, United States
Las Vegas Clinical Trials- Site Number: 8400079
RecruitingLas Vegas, Nevada, 89030, United States
Sanmora Bespoke Clinical Research Solutions LLC-Site Number: 8400123
RecruitingEast Orange, New Jersey, 07018, United States
Allied Health Clinical Research Organization, LLC - Freehold-Site Number: 8400014
RecruitingFreehold, New Jersey, 07728, United States
Tandem-Allied Clinical Research - Somers Point- Site Number: 8400050
RecruitingSomers Point, New Jersey, 08244, United States
Premier Health Research, LLC - Site Number: 8400114
RecruitingSparta, New Jersey, 07871, United States
MedTraits NY-Site Number: 8400045
RecruitingMaspeth, New York, 11378, United States
Manhattan Clinical Research, LLC - Site Number: 8400069
RecruitingNew York, New York, 10016, United States
New York Gastroenterology Associates-Site Number: 8400009
RecruitingNew York, New York, 10075, United States
NYU Langone Health- Site Number: 8400091
RecruitingNew York, New York, 10016, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital-Site Number: 8400040
RecruitingNew York, New York, 10065, United States
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
RecruitingChapel Hill, North Carolina, 27514, United States
OnSite Clinical Solutions-Site Number: 8400051
RecruitingCharlotte, North Carolina, 28211, United States
Cross Creek Medical Clinic-Site Number: 8400057
RecruitingFayetteville, North Carolina, 28304, United States
Monroe Biomedical Research - Site Number: 8400046
RecruitingMonroe, North Carolina, 28112, United States
ClinTrial Research, LLC - Site Number: 8400043
RecruitingRaleigh, North Carolina, 27612, United States
Plains Medical Clinic-Site Number: 8400078
RecruitingFargo, North Dakota, 58104, United States
Gastroenterology & Hepatology Specialists, Inc.-Site Number: 8400139
RecruitingCanton, Ohio, 44718, United States
Ohio Gastroenterology Group Inc.: 8400006
RecruitingColumbus, Ohio, 43202, United States
OSU Wexner Medical Center- Site Number: 8400077
RecruitingColumbus, Ohio, 43210, United States
DSI Research, LLC-Site Number: 8400115
RecruitingDayton, Ohio, 45414, United States
DSI Research, LLC - Site Number: 8400105
RecruitingSpringboro, Ohio, 45066, United States
North Shore Gastroenterology Research - Site Number: 8400130
RecruitingWestlake, Ohio, 44145, United States
Central Sooner Research-Site Number: 8400094
RecruitingNorman, Oklahoma, 73071, United States
University of Pennsylvania School of Medicine- Site Number: 8400072
RecruitingPhiladelphia, Pennsylvania, 19104-6243, United States
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107
RecruitingPittsburgh, Pennsylvania, 15212, United States
University Gastroenterology - GI Alliance - Site Number: 8400103
RecruitingProvidence, Rhode Island, 02904, United States
Biocentric Health Research Partner-Site Number: 8400089
RecruitingWest Columbia, South Carolina, 29169, United States
Tri-Cities Gastroenterology-Site Number: 8400076
RecruitingKingsport, Tennessee, 37663, United States
Valley Institute of Research: 8400004
RecruitingHarlingen, Texas, 78550, United States
One of a Kind Clinical Research Center LLC - Texas-Site Number: 8400125
RecruitingKingwood, Texas, 77339, United States
Innovare Research Group-Site Number: 8400067
RecruitingLake Jackson, Texas, 77566, United States
Texas Digestive Disease Consultants dba GI Alliance - Lubbock - Site Number: 8400092
RecruitingLubbock, Texas, 79410, United States
SMS Clinical Research-Site Number: 8400035
RecruitingMesquite, Texas, 75149, United States
Gastroenterology Research of San Antonio LLC-Site Number: 8400054
RecruitingSan Antonio, Texas, 78229, United States
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Site Number: 8400101
RecruitingSouthlake, Texas, 76092, United States
Texas Gastro Consultants: 8400029
RecruitingTomball, Texas, 77375, United States
Tyler Research Institute, LLC: 8400095
RecruitingTyler, Texas, 75701, United States
Blue Ridge Medical Research: 8400020
RecruitingLynchburg, Virginia, 24502, United States
Clinical Research Partners - Site Number: 8400080
RecruitingRichmond, Virginia, 23226, United States
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
RecruitingVancouver, Washington, 98664, United States
This study also lists 207 locations outside the United States. They are not shown here.
Central study contacts
Trial Transparency email recommended (Toll free for US & Canada)
Contact
Registry dates
- First posted
- Sep 22, 2025
- Primary completion
- May 14, 2029
- Overall completion
- May 14, 2029
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.