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

Conditions

Ulcerative Colitis

Brief summary

Change from baseline in centrally-assessed Mayo endoscopic subscore (MES) at Week 12

Detailed description

1. Clinical remission at Week 12, defined as a modified Mayo Score (mMS) ≤2, all mMS subscores ≤1, and a Rectal Bleeding (RB) subscore of 0, and an SF subscore not greater than baseline, 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, 2. Change from baseline in histologic scores at Week 12 (Robarts’ Histopathology Index [RHI]), 3. (Median) Percent change from baseline in fecal calprotectin (FC) at Week 12, 4. Change from baseline in UC-100 score at Week 12, 5. Change from baseline in PRO-2 at Week 12, 6. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), 7. Treatment-emergent abnormalities in laboratory parameters and vital signs

Related papers

No related papers found yet.

Interventions

DRUGMH002

DRUGPlacebo to match MH002 oral capsule

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in centrally-assessed Mayo endoscopic subscore (MES) at Week 12	—

Secondary

Measure	Time frame
1. Clinical remission at Week 12, defined as a modified Mayo Score (mMS) ≤2, all mMS subscores ≤1, and a Rectal Bleeding (RB) subscore of 0, and an SF subscore not greater than baseline, 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, 2. Change from baseline in histologic scores at Week 12 (Robarts’ Histopathology Index [RHI]), 3. (Median) Percent change from baseline in fecal calprotectin (FC) at Week 12, 4. Change from baseline in UC-100 score at Week 12, 5. Change from baseline in PRO-2 at Week 12, 6. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), 7. Treatment-emergent abnormalities in laboratory parameters and vital signs	—

Measure

Time frame

1. Clinical remission at Week 12, defined as a modified Mayo Score (mMS) ≤2, all mMS subscores ≤1, and a Rectal Bleeding (RB) subscore of 0, and an SF subscore not greater than baseline, 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, 2. Change from baseline in histologic scores at Week 12 (Robarts’ Histopathology Index [RHI]), 3. (Median) Percent change from baseline in fecal calprotectin (FC) at Week 12, 4. Change from baseline in UC-100 score at Week 12, 5. Change from baseline in PRO-2 at Week 12, 6. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), 7. Treatment-emergent abnormalities in laboratory parameters and vital signs

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Outcome results

None listed