Colitis, UlcerativePhase 2StarFish-UCNCT07296315
Confirmatory Clinical Study in Active Ulcerative Colitis
A Phase 2 study testing Low-dose MH002 and High-dose MH002 in people with Colitis, Ulcerative, run by MRM Health NV at 49 sites in 7 countries.
Trial summary
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Low-dose MH002 and High-dose MH002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 49 sitesin 7 countries
- Study dates
- 3 Apr 2026to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of ulcerative colitis (UC) at least 3 months prior to Screening.
- Diagnosis of active mild-to-moderate UC at Screening as defined by an mMS of 4 to 7, including a MES ≥2 (confirmed by central reading), a Mayo Rectal Bleeding score of 1 or 2, and a Mayo Stool Frequency score ≥1.
- UC lesions extending ≥10 cm from the anal verge.
- Participant must either receive a stable dose of orally administered 5-aminosalicylic acid (5-ASA); have failed, due to insufficient efficacy, oral 5-ASA; have a documented intolerance or poor tolerance to an aminosalicylic acid treatment, including 5-ASA, or be contra-indicated to receive 5-ASA treatment per local labeling.
- Participant must provide written informed consent or assent (parent or legal guardian must provide consent for a participant <18 years of age who has assented to participate in the study, or as required per local regulations).
- In countries not allowing females of childbearing potential (FOCBP) to participate without an acceptable contraceptive method, the FOCBP must agree to abide to local requirements and eg, use at least an acceptable method of contraception until the end of treatment.
Who cannot join
- Diagnosis of Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon.
- Evidence of a clinically significant, active infection of the gastrointestinal tract.
- Severe UC (mMS>7), meeting modified Truelove Witts' criteria and/or RB score of 3, participant with ulcerative proctitis only, or participant in whom colitis is most severe in the transverse colon or ascending colon, or if any hospitalization is planned at the time of Screening.
- Total colectomy, stoma, or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon.
- Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC.
- History of colon carcinoma or high-grade dysplasia.
Show all 21Show fewer
- Previous use of any advanced UC treatment, including any anti-TNF (eg, infliximab), antiintegrin (eg, vedolizumab) or anti-IL-12/23 (eg, ustekinumab) agent, anti-IL23 (eg, risankizumab), Janus kinase inhibitors (eg, tofacitinib), and sphingosine-1-phosphate receptor modulators (eg, etrasimod).
- Use of sulfasalazine ≤4 weeks prior to randomization.
- Use of corticosteroids or any disease-modifying antirheumatic drugs (DMARD), including thiopurines, ≤6 weeks prior to randomization into the study, except for a stable, low dose of oral corticosteroids (≤10 mg prednisolone/day) for at least 2 weeks prior to Screening colonoscopy and up to at least the Week 12 visit.
- Use of antibiotics (except for local use), prebiotics, or probiotics ≤4 weeks prior to randomization or anticipated during study participation, or concomitant, chronic use of an antidiarrheal drug, or concomitant use of any rectal treatment.
- Use of fecal microbiota transplantation (FMT) ≤52 weeks prior to randomization.
- Treatment with another investigational drug or intervention within 30 days prior to Screening, or within 5 times the elimination half-life of the investigational drug (whichever is longest).
- Any immunocompromised state, including conditions linked to severe immunosuppression (eg, active human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy).
- Leukopenia (total white blood cell count <3000/μL) and/or neutropenia (absolute neutrophil count <1000/μL), anemia (hemoglobin <10.0 g/dL), thrombocytopenia (peripheral blood platelet count <100 × 10^9/L), and/or any coagulation disorder with significantly increased risk of bleeding.
- Ongoing or recent (<3 months) renal disease or insufficiency as manifested, eg, by medical history and/or clinical examination and/or (calculated or measured) glomerular filtration rate ≤60 mL/min.
- Ongoing or recent (<3 months) advanced hepatic dysfunction defined as a Child Pugh score ≥10 (Class C), or increase ≥2 times the upper limit of normal in aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) or international normalised ratio (INR).
- Clinically significant bone marrow disease if progressive or not controlled, or any history of solid organ or bone marrow transplantation.
- Active intravenous drug abuse or alcohol abuse disorder as assessed by the Investigator.
- Pregnancy or lactation at study entry. Note: Participants who become pregnant or start to breastfeed during the study may continue the study per the Investigator's discretion.
- Participants who are inappropriate for the study per the Investigator's discretion.
- An employee (or a relative of) of the Investigator, study center, contract research organization, or Sponsor.
Trial locations and contacts
49 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Carmen Fleurinck, MD contact
49 sites in 7 countries
Ukraine11 sites, 11 recruiting
- Recruiting
Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital"
Chernivtsi, 58001
Oleksandr Fediv
- Recruiting
Communal Non-Profit Enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, 76008
Vira Vyshynanyuk
- Recruiting
LLC "Treatment and Diagnostic Center "Adonis Plus"
Kyiv, 02002
Yurii Zakharash
- Recruiting
Medical Center "Artes Medicum" LLC
Kyiv, 02002
Mykhailo Pugach
- Recruiting
Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"
Kyiv, 02091
Svitlana Skybalo
- Recruiting
Limited Liability Company "Medical Centre "Consilium Medical"
Kyiv, 04050
Oksana Gerasymenko
- Recruiting
Limited Liability Company "Center of Family Medicine Plus"
Kyiv, 04210
Liudmyla Chupryna
- Recruiting
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, 79010
Yaroslav Zborivskyy
- Recruiting
Public Non-Profit Enterprise "Andrii Novak Zakarpattia Regional Clinical Hospital" under Zakarpattia Regional Council
Uzhhorod, 88000
Yaroslava Rishko
- Recruiting
Municipal Non-Commercial Enterprise "Uzhhorod City Multidisciplinary Clinical Hospital" of Uzhhorod City Council
Uzhhorod, 88009
Ivan Chopei
- Recruiting
Limited Liability Company "Treatment and Diagnostic Center "Gastroclinic"
Vinnytsia, 21021
Anna Yurets
Georgia9 sites, 9 recruiting
- Recruiting
JSC Georgian Clinics
Kutaisi, 4600
Davit Jugeli
- Recruiting
American Hospital Network LLC
Tbilisi, 0102
Tengiz Telia
- Recruiting
K. Eristavi National Center of Experimental and Clinical Surgery JSC
Tbilisi, 0159
Tamta Nikolaishvili
- Recruiting
LTD Institute of Clinical Cardiology
Tbilisi, 0159
Irina Jashi
- Recruiting
Aversi Clinic LLC
Tbilisi, 0160
Nino Kiknadze
- Recruiting
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0178
Giga Sordia
- Recruiting
LLC The First Medical Center
Tbilisi, 0180
Ekaterine Labadze
- Recruiting
LTD Krol Medical Corporation
Tbilisi, 0180
Rusudan Shonia
- Recruiting
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi, 0180
Khatuna Gargulia
Poland9 sites, 9 recruiting
- Recruiting
CLINSANTE Civil Law Partnership Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, 85-794
Michal Walczak
- Recruiting
Vita Longa Non-Public Healthcare Facility, Limited Liability Company
Katowice, 40-748
Ramos Przemyslaw
- Recruiting
Oslomed Medical Center
Krakow, 31-228
Anna Drozdz
- Recruiting
EMC Medical Institute Joint Stock Company
Poznan, 60-309
Piotr Szablowski
- Recruiting
Private Healthcare Institution Specialist Clinics Termedica
Poznan, 60-681
Maciej Mazur
- Recruiting
Endoskopia Sp. z o.o. (LLC)
Sopot, 81-756
Dariusz Kleczkowski
- Recruiting
Medon Clinical Research
Warsaw, 02-679
Anna Bochenek-Mularczyk
- Recruiting
Medical Network Sp. z o.o. - WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
Jaroslaw Kierkus
- Recruiting
Clinical Research Center Early-Phase Research Facility
Wroclaw, 51-162
Piotr Napora
Serbia7 sites, 7 recruiting
- Recruiting
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11000
Igor Jovanovic
- Recruiting
Clinical Hospital Center Dr. Dragisa Misovic-Dedinje
Belgrade, 11000
Aleksandra Pavlovic
- Recruiting
Zvezdara University Medical Center
Belgrade, 11000
Petar Svorcan
- Recruiting
General Hospital Leskovac
Leskovac, 16000
Tasic Tomislav
- Recruiting
General Hospital Pancevo
Pančevo, 26000
Tatjana Djorovic
- Recruiting
General Hospital 'Dr Radivoj Simonovic' Sombor
Sombor, 25000
Djordje Orlovic
- Recruiting
Health Center Užice
Užice, 31000
Danijela Savic
United States6 sites, 6 recruiting
- Recruiting
Cross Creek Medical Clinic
Fayetteville, North Carolina, 28304
Nitinchandra D. Desai
- Recruiting
Peters Medical Research
High Point, North Carolina, 27260
Roy Peters
- Recruiting
ARA Professionals
Miami, Florida, 33155
Sergio Rodriguez
- Recruiting
Orlando Gastroenterology, P.A.
Orlando, Florida, 32835
Sri Pothamsetty
- Recruiting
Tropical Clinical Trials
Palmetto Bay, Florida, 33176
Michael Feldman
- Recruiting
Southern Star Research Institute
San Antonio, Texas, 78229
Jeff Bullock
Moldova4 sites, 4 recruiting
- Recruiting
Sf. Arhanghel Mihail" Municipal Clinical Hospital
Chisinau, 2005
Loreta Esanu
- Recruiting
PMSI "Timofei Mosneaga" Republican Clinical Hospital
Chisinau, MD-2025
Svetlana Turcan
- Recruiting
PMSI "Timofei Mosneaga" Republican Clinical Hospital
Chisinau, MD2025
Victoria Babitchi
- Recruiting
"Sfanta Treime" Municipal Clinical Hospital
Chisinau, MD2068
Gheorghe Lupu
Czechia3 sites, 3 recruiting
- Recruiting
Military Hospital Brno, Internal Department
Brno, 61500
David Stepek
- Recruiting
Thomayer University Hospital, Clinic of Internal Medicine
Prague, 14000
Pavel Kohout
- Recruiting
Endohope Clinic s.r.o.
Prague, 15000
Lukas Bajer
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to- Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated.
MH002 is a live biotherapeutic product (LBP). This is a biological medicine containing live bacteria used to restore the normal function of a gut that is damaged by ulcerative colitis (UC). Ulcerative colitis is a bowel disease that causes inflammation and sores in the gut.
- Conditions
- Colitis, Ulcerative
- Being tested
- Low-dose MH002, High-dose MH002, Placebo
- Keywords
- 5-aminosalicylic-acid, live biotherapeutic product, ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose MH002Drug
Microbiome-based live biotherapeutic product consisting of 6 wildtype commensal strains at a dose of 1 × 10^10 equivalent colony forming units [eqCFU]), administered orally (in a capsule) once daily
High-dose MH002Drug
Microbiome-based live biotherapeutic product consisting of 6 wildtype commensal strains at a dose of 4 × 10^10 equivalent colony forming units [eqCFU]), administered orally (in a capsule) once daily
PlaceboDrug
Blank placebo administered orally (in a capsule) once daily
| Study group | Role | What they receive |
|---|---|---|
| Low-dose MH002 | Experimental | Not described Receives: Drug: Low-dose MH002 |
| High-dose MH002 | Experimental | Not described Receives: Drug: High-dose MH002 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in centrally-assessed Mayo Endoscopic Subscore (MES) at Week 12.
The MES ranges from 0 to 3, with higher scores indicating more severe disease.
Measured: Week 12
Secondary outcomes (6)
To confirm the efficacy of MH002 to induce clinical remission at Week 12
Key secondary endpoint: Clinical remission is defined as a modified Mayo Score (mMS) ≤2, all mMS subscores ≤1, and an Rectal Bleeding (RB) subscore of 0, with endoscopic MES based on worst segment assessed by a blinded central reader, and 2-item Patient-Reported Outcome (PRO-2) scores computed from the e-diary data
Measured: Week 12
Change from baseline in histologic scores Robarts' Histopathology Index (RHI) at Week 12
The RHI score ranges from 0 to 33, with higher scores indicating more severe disease activity.
Measured: Week 12
(Median) Percent change from baseline in fecal calprotectin (FC) at Week 12
Measured: Week 12
Change from baseline in UC-100 score at Week 12
The UC-100 is a composite disease activity index consisting of clinical, endoscopic, and histological findings. The UC-100 score ranges from 1 to 100, with higher scores indicating more severe disease activity.
Measured: Week 12
Change from baseline in PRO-2 score at Week 12
2-item Patient-Reported Outcome (PRO-2) scores computed from the e-diary data on stool frequency and rectal bleed. The PRO-2 score ranges from 0 to 6, with higher scores indicating more severe disease.
Measured: Week 12
To confirm the safety and tolerability of MH002 in the Induction Phase
Incidence of Treatment-Emergent Adverse Events, Serious Adverse events Incidence of Treatment-emergent abnormalities in laboratory parameters and vital signs during 12 weeks treatment period.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start3 Apr 2026
- Primary completionSep 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MRM Health NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ludo Haazen, MD, Study chair, MRM Health NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296315
- Sponsor's protocol ID
- MH002-UC-202
- Acronym
- StarFish-UC
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to- Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid
- ClinicalTrials.gov ID
- NCT07296315
- Acronym / sponsor ID
- StarFish-UC / MH002-UC-202
- Conditions
- Colitis, Ulcerative
- Keywords
- 5-aminosalicylic-acid, live biotherapeutic product, ulcerative colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- MRM Health NVIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated.
MH002 is a live biotherapeutic product (LBP). This is a biological medicine containing live bacteria used to restore the normal function of a gut that is damaged by ulcerative colitis (UC). Ulcerative colitis is a bowel disease that causes inflammation and sores in the gut.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose MH002 | Experimental | Drug: Low-dose MH002 |
| High-dose MH002 | Experimental | Drug: High-dose MH002 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of ulcerative colitis (UC) at least 3 months prior to Screening.
- Diagnosis of active mild-to-moderate UC at Screening as defined by an mMS of 4 to 7, including a MES ≥2 (confirmed by central reading), a Mayo Rectal Bleeding score of 1 or 2, and a Mayo Stool Frequency score ≥1.
- UC lesions extending ≥10 cm from the anal verge.
- Participant must either receive a stable dose of orally administered 5-aminosalicylic acid (5-ASA); have failed, due to insufficient efficacy, oral 5-ASA; have a documented intolerance or poor tolerance to an aminosalicylic acid treatment, including 5-ASA, or be contra-indicated to receive 5-ASA treatment per local labeling.
- Participant must provide written informed consent or assent (parent or legal guardian must provide consent for a participant <18 years of age who has assented to participate in the study, or as required per local regulations).
Key exclusion criteria (21 listed)
- Diagnosis of Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon.
- Evidence of a clinically significant, active infection of the gastrointestinal tract.
- Severe UC (mMS>7), meeting modified Truelove Witts' criteria and/or RB score of 3, participant with ulcerative proctitis only, or participant in whom colitis is most severe in the transverse colon or ascending colon, or if any hospitalization is planned at the time of Screening.
- Total colectomy, stoma, or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon.
- Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose MH002Microbiome-based live biotherapeutic product consisting of 6 wildtype commensal strains at a dose of 1 × 10^10 equivalent colony forming units [eqCFU]), administered orally (in a capsule) once daily | Drug | Low-dose MH002 |
| High-dose MH002Microbiome-based live biotherapeutic product consisting of 6 wildtype commensal strains at a dose of 4 × 10^10 equivalent colony forming units [eqCFU]), administered orally (in a capsule) once daily | Drug | High-dose MH002 |
| PlaceboBlank placebo administered orally (in a capsule) once daily | Drug | Placebo |
Primary outcome
Change from baseline in centrally-assessed Mayo Endoscopic Subscore (MES) at Week 12.
Time frame: Week 12
The MES ranges from 0 to 3, with higher scores indicating more severe disease.
6 secondary outcomes
To confirm the efficacy of MH002 to induce clinical remission at Week 12
Time frame: Week 12
Change from baseline in histologic scores Robarts' Histopathology Index (RHI) at Week 12
Time frame: Week 12
(Median) Percent change from baseline in fecal calprotectin (FC) at Week 12
Time frame: Week 12
Change from baseline in UC-100 score at Week 12
Time frame: Week 12
Change from baseline in PRO-2 score at Week 12
Time frame: Week 12
To confirm the safety and tolerability of MH002 in the Induction Phase
Time frame: Up to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carmen Fleurinck, MD contact
Ludo Haazen, MD study chair
MRM Health NV
49 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose MH002 and High-dose MH002 in people with Colitis, Ulcerative, run by MRM Health NV at 49 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Ukraine, Georgia, Poland, Serbia, United States and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Els Callebaut (+32 9 277 08 50, clinicaltrials@mrmhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in centrally-assessed Mayo Endoscopic Subscore (MES) at Week 12. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.