Health Trials

Confirmatory Clinical Study in Active Ulcerative Colitis

ConditionColitis, Ulcerative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorMRM Health NV

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

  • Placebo

    Drug

    Blank placebo administered orally (in a capsule) once daily

Treatment groups

204 Participants
are divided into 3 treatment groups
Group A: Low-dose MH002Experimental treatment 1 intervention
Group B: High-dose MH002Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Week 12

Secondary outcomes

1

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

Time frame
Week 12
2

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.

Time frame
Week 12
3

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

Time frame
Week 12
4

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.

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MRM Health NV

Lead sponsor

Source ClinicalTrials.gov
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