Confirmatory Clinical Study in Active Ulcerative Colitis

NCT07296315 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MH002-UC-202
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 5

Brief 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. 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

Keywords

5-aminosalicylic-acid; live biotherapeutic product; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (6)

• To confirm the efficacy of MH002 to induce clinical remission at Week 12

  Week 12

• Change from baseline in histologic scores Robarts' Histopathology Index (RHI) at Week 12

  Week 12

• (Median) Percent change from baseline in fecal calprotectin (FC) at Week 12

  Week 12

• Change from baseline in UC-100 score at Week 12

  Week 12

• Change from baseline in PRO-2 score at Week 12

  Week 12

Study Arms (3)

Low-dose MH002

EXPERIMENTAL

Drug: Low-dose MH002

High-dose MH002

EXPERIMENTAL

Drug: High-dose MH002

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Blank placebo administered orally (in a capsule) once daily

Placebo

Low-dose MH002 DRUG

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

Low-dose MH002

High-dose MH002 DRUG

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

High-dose MH002

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MRM Health NV: lead

Study Sites (5)

ARA Professionals

Miami, Florida, 33155, United States

NOT YET RECRUITING

Tropical Clinical Trials

Palmetto Bay, Florida, 33176, United States

NOT YET RECRUITING

Cross Creek Medical Clinic

Fayetteville, North Carolina, 28304, United States

NOT YET RECRUITING

Peters Medical Research

High Point, North Carolina, 27260, United States

RECRUITING

Southern Star Research Institute

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ludo Haazen, MD

  MRM Health NV

  STUDY CHAIR

Central Study Contacts

Jean-Michel Muhlinghaus, DVM

CONTACT

+32 9 277 08 50; clinicaltrials@mrmhealth.com

Carmen Fleurinck, MD

CONTACT

+32 9 277 08 50

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: December 22, 2025
• Study Start: April 3, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)