Ulcerative Colitis
Duvakitug Induction Study for Moderate-to-Severe Ulcerative Colitis
This Phase 3 study is investigating the effects and safety of injected duvakitug, compared with placebo in part of the study, in people with moderately to severely active ulcerative colitis.
Registry title: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
118 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
Among people with moderately to severely active ulcerative colitis, what effects and safety findings are observed during induction treatment with duvakitug, including when compared with placebo?
Participant snapshot
Who the study is looking for
- The study is looking for people with moderately to severely active ulcerative colitis confirmed at least three months before baseline.
- Participants are generally 18 to 80 years old; where locally permitted, people ages 16 to under 18 may participate if they meet Tanner Stage 5.
- The study is looking for people whose ulcerative colitis responded inadequately, stopped responding, or was not tolerated with conventional or advanced therapies.
- The study lists recruiting locations in the United States and multiple other countries, although the study team must confirm whether a specific site is currently open.
Participation overview
What participation may involve
Participants may enter a 12-week open-label feeder induction or pivotal induction sub-study. Non-responders may enter a further 12-week extended induction. Treatment consists of subcutaneous injections of duvakitug or, in the placebo group, placebo. What participation may involve: - Receive study treatment by subcutaneous injection according to the protocol. - Undergo assessments of ulcerative colitis activity, including symptoms and endoscopic findings. - Complete patient-reported assessments covering fatigue, bowel urgency, abdominal pain, and inflammatory bowel disease-related quality of life. - Provide blood samples for measurement of duvakitug concentration and anti-drug antibodies. - Have adverse events monitored through 45 days after the last dose. The registry states that participation may last up to 35 weeks. Each sub-study has up to 12 weeks of treatment, and people who do not enter the maintenance study have a follow-up visit 45 days later. The registry reports up to eight scheduled on-site visits for Sub-Study 1 or 2 and up to 15 visits for participants who complete extended induction.
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 this record.
- Placebo: The placebo is a solution given by subcutaneous injection in the placebo-comparator group.
Study design
How the comparison works
This multinational Phase 3 induction study has multiple sub-studies. The registry describes a single-arm, open-label feeder induction and a pivotal randomized, parallel-group, placebo-controlled induction, with extended induction available for non-responders. The registry classifies the overall study as randomized with parallel groups, although it also describes one feeder sub-study as single-arm and open-label. For the blinded design, the participant, care provider, investigator, and outcomes assessor are masked to assigned treatment. The feeder sub-study is described separately as open-label. The pivotal induction includes a placebo injection group for comparison with two duvakitug dose groups. A placebo is given by subcutaneous injection in one study group, but the record does not state an individual participant's probability of receiving it.
Reported activities
Procedures and tests
- Subcutaneous study injections
- Modified Mayo Score assessment of ulcerative colitis activity, including stool frequency, rectal bleeding, and endoscopic findings
- Endoscopic assessment, with images assessed by a blinded central reader for an endoscopic outcome
- Histological and endoscopic mucosal assessment using the Geboes and endoscopic scores
- PROMIS-Fatigue Short Form questionnaire about fatigue and daily functioning
- Symptom assessments for stool frequency, rectal bleeding, and nighttime bowel movements
- Bowel-urgency rating on an 11-point numeric scale
- Abdominal-pain rating on an 11-point numeric scale
- Inflammatory Bowel Disease Questionnaire assessing quality of life
- Monitoring of ulcerative colitis-related hospitalization and steroid use
- Monitoring for adverse events, serious adverse events, events of special interest, and events leading to permanent discontinuation
- Blood testing for serum duvakitug concentration
- Blood testing for 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 must generally be 18 through 80 years old at screening.
- Where local rules allow, participants ages 16 to under 18 must meet the definition of Tanner Stage 5 development.
- A diagnosis of moderately to severely active ulcerative colitis 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 ulcerative colitis therapies.
Possible reasons someone may not be able to join
- People with Crohn's disease or indeterminate colitis are excluded.
- A current diagnosis of ulcerative proctitis is excluded.
- People are excluded if they had surgical bowel resection within three months before baseline or have a history of more than three bowel resections.
- Prior or current high-grade gastrointestinal dysplasia is excluded.
- The registry excludes some participants taking conventional therapies without stable doses before baseline, but the criterion's wording is incomplete.
- Use of protocol-prohibited medications or therapies before baseline is excluded; the registry does not identify them.
- Previous exposure to an investigational therapy targeting TL1A is excluded.
Important unknowns
What the record does not make clear
- The study has two duvakitug dose groups and a placebo group, but allocation ratios and an individual's chance of receiving placebo are not reported.
- The criteria refer to stable doses of conventional therapies, but the record does not clearly identify which ulcerative colitis treatments may continue during the study.
- The record mentions prohibited medications or therapies before baseline but does not name them or provide timing requirements.
- The record does not explain what rescue treatment is available if ulcerative colitis worsens during induction.
- Endoscopic outcomes are reported, but the number and timing of required endoscopies are not clearly stated.
- The record does not state which study-related or routine-care costs are covered or billed to insurance.
- The record does not state whether participants receive compensation.
- The record does not state whether transportation, lodging, parking, or other travel support is available.
- Scheduled on-site visits are reported, but the record does not say whether any other visits or assessments can be completed remotely.
- The record mentions a separate maintenance study but does not explain who may enter it or whether duvakitug is otherwise available after this induction study.
- The overall study is recruiting and many sites are listed as recruiting, but this does not establish that every cohort or site has space for a particular participant.
Before contacting the site
Questions for the study team
- Which sub-study would I be screened for, and how is that decision made?
- What are the duvakitug doses and injection schedule in each group?
- If I enter the randomized sub-study, what is my chance of receiving placebo?
- Which current treatments must remain stable, stop, or undergo a washout before baseline?
- How many endoscopies and biopsies are required, and when will they occur?
- What happens if my ulcerative colitis worsens or I do not respond during induction?
- Which costs are covered, and are compensation or travel assistance available?
- Is the relevant sub-study currently enrolling at my preferred site?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what risks would treatment changes or a possible placebo assignment create in my clinical situation?
- Which of my current medicines should not be interrupted without a coordinated plan with the study team?
- What approved treatment alternatives remain available for my ulcerative colitis, and how do their known tradeoffs compare with research participation?
- How should you and the research team coordinate symptom monitoring, endoscopy results, medication changes, and care if my disease worsens?
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 to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: * 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) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
Study design and administration
- Organization
- Sanofi
- Organization class
- Industry
- Organization study ID
- EFC18325
- 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:Solution for Injection-Route of administration:SC injection
Drug
Placebo
Pharmaceutical form:Solution for injection-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 UC 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 therapiesRegistry-derived · unreviewed
Exclusion criteria (7)
- Participants with Crohn's Disease (CD), indeterminate colitisRegistry-derived · unreviewed
- Current diagnosis of Ulcerative ProctitisRegistry-derived · unreviewed
- Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \>3 bowel resectionsRegistry-derived · unreviewed
- Prior or current high-grade gastrointestinal (GI) dysplasiaRegistry-derived · unreviewed
- Participants on treatment with but not on stable doses of conventional therapies prior to baselineRegistry-derived · unreviewed
- Participants with prohibited medications or therapies prior to baselineRegistry-derived · unreviewed
- Participants with previous exposure to anti-TL1A investigational therapy 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
Proportion of participants achieving clinical remission.
Time frame: Week 12
Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including SFS of 0 or 1, RBS of 0, and modified Mayo Endoscopic Score (MES) of 0 or 1 (score of 1 modified to exclude friability). mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.
Secondary outcome
Proportion of participants who achieve endoscopic improvement.
Time frame: Week 12
Endoscopic improvement is defined as MES of 0 or 1 (score of 1 excludes friability). Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Secondary outcome
Proportion of participants achieving clinical response by modified Mayo Score (mMS).
Time frame: Week 12
Clinical response is defined as a decrease from baseline in the mMS of ≥2 points and at least a 30% reduction from baseline, and a decrease in RB subscore of ≥1 or an absolute RB subscore of 0 or 1. mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.
Secondary outcome
Proportion of participants achieving histological endoscopic mucosal improvement.
Time frame: Week 12
Histological endoscopic mucosal improvement is defined as MES of 0 or 1 without the evidence of friability and Geboes Score ≤3.1. The Geboes score has 6 grades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Secondary outcome
Change from baseline in PROMIS-Fatigue Short Form 7a T-score.
Time frame: Baseline, Week 12
The PROMIS-Fatigue Short Form 7 is a tool that assessesfatigue severity and its impact on daily functioning over the past week.
Secondary outcome
Proportion of participants with symptomatic (SFS and RBS) remission
Time frame: Week 12
Symptomatic remission (SF and RB): stool-frequency sub score (SFS ) of 0 or 1, and rectal bleeding sub score (RBS) of 0.
Secondary outcome
Proportion of participants with no bowel urgency.
Time frame: Week 12
The NRS for bowel urgency is a patient-reported tool designed to measure 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, where 0 represents "no urgency" and 10 signifies the "worst possible urgency".
Secondary outcome
Proportion of participants reporting no nocturnal bowel movements.
Time frame: Week 12
Secondary outcome
Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.
Time frame: Week 4
Symptomatic response is defined as ≥30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS.
Secondary outcome
Proportion of participants who achieve endoscopic remission.
Time frame: Week 12
Endoscopic remission is defined as mMES of 0.
Secondary outcome
Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS).
Time frame: Week 12
The abdominal pain NRS is a tool to rate the severity of abdominal pain over the past 24 hours using a score of 0 ("no pain") to 10 ("worst possible pain").
Secondary outcome
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.
Time frame: Baseline, Week 12
IBDQ is a tool to the quality of life of individuals suffering from IBD. The total score ranges from 32 to 224, with higher scores correlating to a better quality of life.
Secondary outcome
Proportion of participants with UC-related hospitalization.
Time frame: Baseline through Week 12
Secondary outcome
Proportion of participants achieving clinical remission and no steroid use.
Time frame: Week 12
Secondary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation.
Time frame: Baseline through 45 days after last dose
Secondary outcome
Serum concentration of duvakitug measured over time.
Time frame: Baseline through Week 12
Secondary outcome
Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.
Time frame: Baseline through 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
Scottsdale Clinical Trials - Site Number: 8400145
RecruitingScottsdale, Arizona, 85260, United States
Del Sol Research Management, LLC - Site Number: 8400012
RecruitingTucson, Arizona, 85715, United States
Preferred Research Partners - Site Number: 8400018
RecruitingLittle Rock, Arkansas, 72211, United States
FOMAT - Unio Specialty Care Arcadia - Site Number: 8400027
RecruitingArcadia, California, 91006, United States
Alliance Research Institute - 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
Om Research, LLC - Lancaster - Site Number: 8400148
RecruitingLancaster, California, 93534, United States
TLC Clinical Research Inc. - Site Number: 8400030
RecruitingLos Angeles, California, 90048, United States
United Medical Doctors CA - Site Number: 8400044
RecruitingMurrieta, California, 92563, United States
Om Research, LLC - Oxnard - Site Number: 8400150
RecruitingOxnard, California, 93030, 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
Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025
RecruitingSanta Maria, California, 93458, United States
Valiance Clinical Research - Tarzana - Site Number: 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
UCHealth Digestive Health Center - Anschutz Medical Campus - Site Number: 8400085
RecruitingAurora, Colorado, 80045, 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
Yale University Digestive Disease - Site Number: 8400108
RecruitingNew Haven, Connecticut, 06510, United States
Novum Research, LLC - Site Number: 8400003
RecruitingClermont, Florida, 32803, United States
Precision Clinical Research-Site Number: 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
Sylvester Comprehensive Cancer Center - A University of Miami Hospital and Clinics Facility - Miami - Site Number: 8400111
RecruitingMiami, Florida, 33136, United States
AdventHealth Orlando - Site Number: 8400070
RecruitingOrlando, Florida, 90067, 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 - Site Number: 8400028
RecruitingSandy Springs, Georgia, 30328, United States
EBGS Clinical Research Center, LLC - Site Number: 8400037
RecruitingSnellville, Georgia, 30078, United States
Atlanta Gastroenterology Specialists - Site Number: 8400149
RecruitingSuwanee, Georgia, 30024, United States
Grand Teton Research Group, PLLC - Site Number: 8400127
RecruitingIdaho Falls, Idaho, 83404, United States
Rush University Medical Center - Site Number: 8400015
RecruitingChicago, Illinois, 60612, United States
Midwest Digestive Health and Nutrition - Site Number: 8400136
RecruitingDes Plaines, Illinois, 60016, United States
GI Alliance - Glenview - Site Number: 8400068
RecruitingGlenview, Illinois, 60026, 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
Iowa Digestive Disease Center - Site Number: 8400134
RecruitingClive, Iowa, 50325, United States
Cedar Valley Digestive Health Center - Site Number: 8400096
RecruitingWaterloo, Iowa, 50701, United States
University of Kansas Medical Center - Site Number: 8400110
RecruitingKansas City, Kansas, 66160, United States
University of Kentucky Hospital/UK Albert B. Chandler Hospital - Site Number: 8400058
RecruitingLexington, Kentucky, 40536-0293, United States
GI Alliance - Baton Rouge - Site Number: 8400129
RecruitingBaton Rouge, Louisiana, 70809, United States
Tandem Intermediate, LLC - Houma -Site Number: 8400034
RecruitingHouma, Louisiana, 70072, United States
GastroGroup - 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
RecruitingMonroe, Louisiana, 71291, United States
Care Access - New Iberia - Site Number: 8400031
RecruitingNew Iberia, Louisiana, 70560, United States
Mercy Medical Center, Baltimore - Site Number: 8400117
RecruitingBaltimore, Maryland, 21202, United States
Mid-Atlantic GI Research, LLC - Site Number: 8400106
RecruitingGreenbelt, Maryland, 20770, United States
Tufts Medical Center - Site Number: 8400126
Not Yet RecruitingBoston, Massachusetts, 02111, 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
Gateway Gastroenterology - Site Number: 8400097
RecruitingChesterfield, Missouri, 63017, United States
BVL Clinical Research - Site Number: 8400005
RecruitingLiberty, Missouri, 64068, United States
Las Vegas Clinical Trials - Site Number: 8400079
RecruitingLas Vegas, Nevada, 89128, United States
SMS Clinical Research - Site Number: 8400035
RecruitingMesquite, Nevada, 75043, 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
Allied Health Clinical Research Organization, LLC - Jackson - Site Number: 8400007
RecruitingJackson, New Jersey, 08527, United States
Tandem-Allied Clinical Research - Somers Point - Site Number: 840050
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
Lenox Hill Hospital - Site Number: 8400052
RecruitingNew York, New York, 10075, 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
Montefiore Medical Center - Bronx - Site Number. 8400142
RecruitingThe Bronx, New York, 10467, 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
Duke University Medical Center - Site Number: 8400093
RecruitingDurham, North Carolina, 27710, 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. - Site Number: 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
University of Toledo Medical Center - Site Number: 8400042
RecruitingToledo, Ohio, 43614, 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
Oregon Health & Science University, Center for Health and Healing 2 - Site Number: 8400131
RecruitingPortland, Oregon, 97239-3098, United States
Penn State Milton S. Hershey Medical Center - Site Number: 8400066
RecruitingHershey, Pennsylvania, 17033-0850, 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
RecruitingWest Columbia, South Carolina, 29169, United States
Inquest Clinical Research - Site Number: 8400144
RecruitingBaytown, Texas, 77521, United States
The University of Texas Southwestern Medical Center - Site Number: 8400098
RecruitingDallas, Texas, 75390, United States
Valley Institute of Research - Site Number: 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
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 - Site Number: 8400029
RecruitingTomball, Texas, 77375, United States
Tyler Research Institute, LLC - Site Number: 8400095
RecruitingTyler, Texas, 75701, United States
Velocity Clinical Research, Salt Lake City - Site Number: 8400147
RecruitingWest Jordan, Utah, 84088, United States
Blue Ridge Medical Research - Site Number: 8400020
RecruitingLynchburg, Virginia, 24502, United States
Clinical Research Partners - Site Number: 8400080
RecruitingRichmond, Virginia, 23226, United States
GI Alliance - Bellevue - Site Number: 8400143
RecruitingBellevue, Washington, 98004, United States
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
RecruitingVancouver, Washington, 98664, United States
This study also lists 101 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 9, 2028
- Overall completion
- May 9, 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.