A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-2)

Moderately to severely active ulcerative colitis

Primary Efficacy: Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS). The mMCS is a composite of the following subscores: - Mayo endoscopic subscore (MES) - Mayo Clinic Score (MCS) stool frequency subscore - MCS rectal bleeding subscore

Secondary Efficacy: Proportion of participants with clinical response at Week 12 as determined using the mMCS, Exploratory Efficacy: Proportion of participants in clinical remission at Week 52 as determined using the mMCS, Exploratory Efficacy: Proportion of participants with clinical response at Week 52 as determined using the mMCS, Exploratory Efficacy: Proportion of participants in MCS remission at Weeks 12 and 52. MCS is a composite of the following subscores: MES; MCS stool frequency subscore ; MCS rectal bleeding subscore; MCS Physician’s Global Assessment (PGA), Exploratory Efficacy: Proportion of participants with MCS response at Weeks 12 and 52, Exploratory Efficacy: - Proportion of participants in histologic remission at Weeks 12 and 52 as determined using the Robarts Histopathology Index (RHI) Score - Proportion of participants in histologic remission at Weeks 12 and 52 as determined using the Nancy Histopathology Index (NI) - Proportion of participants in histologic remission at Weeks 12 and 52 as determined using the Continuous Geboes Score, Exploratory Efficacy: Proportion of participants with histologic improvement at Weeks 12 and 52 as determined using the RHI, Exploratory Efficacy: Proportion of participants with endoscopic improvement at Weeks 12 and 52 as determined using the MES, Exploratory Efficacy: Proportion of participants in endoscopic remission at Weeks 12 and 52 as determined using the MES, Exploratory Efficacy: Proportion of participants in endoscopic remission as determined using the MES and histologic remission as determined using the RHI at Weeks 12 and 52, Exploratory Efficacy: Proportion of participants with endoscopic improvement as determined using the MES and a histologic improvement as determined using the RHI at Weeks 12 and 52, Exploratory Efficacy: Proportion of participants with symptomatic response at Weeks 2 and 6 as determined using the Partial mMCS. Partial mMCS is a composite of the following subscores:MCS stool frequency subscore; MCS rectal bleeding subscore, Exploratory Efficacy: Proportion of participants with Partial MCS response at Week 6. Partial MCS is a composite of the following subscores: MCS stool frequency subscore; MCS rectal bleeding subscore; MCS PGA, Exploratory Efficacy: Time to symptomatic response by Week 12 as determined using the Partial mMCS, Exploratory Efficacy: - Change from baseline to Weeks 12 and 52 in high sensitivity C reactive protein (hs CRP) levels - Change from baseline to Weeks 12 and 52 in fecal calprotectin levels, Exploratory Efficacy: Change from baseline to Weeks 12 and 52 in Inflammatory Bowel Disease Questionnaire (IBDQ) Score, Exploratory Efficacy: Proportion of participants in corticosteroid free remission at Week 52, as determined using the mMCS, among the participants who were on a stable dose of corticosteroids at baseline, Exploratory Efficacy: Percentage of participants requiring UC related hospitalization or surgery at Weeks 12 and 52, Exploratory Efficacy: • Proportion of participants in histologic remission at Week 104 as determined using the RHI • Proportion of participants in histologic remission at Week 104 as determined using the NI • Proportion of participants in histologic remission at Week 104 as determined using the Continuous Geboes Score • Proportion of participants with histologic improvement at Week 104 as determined using the RHI, Exploratory Efficacy: • Proportion of participants with endoscopic improvement at Week 104 as determined using MES • Proportion of participants in endoscopic remission at Week 104 as determined using MES • Proportion of participants in endoscopic remission as determined using MES and histologic remission as determined using RHI at Week 104 • Proportion of participants with endoscopic improvement as determined using MES and a histologic improvement as determined using RHI at Week 104, Safety: Frequencies and proportions for treatment emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation., Pharmacokinetics: MORF-057 concentration in plasma, Exploratory Pharmacodynamics: - α4β7 receptor occupancy in blood over time - α4β1 receptor occupancy in blood over time - Change from baseline over time in blood CCR9 messenger ribonucleic acid (mRNA) - Change from baseline over time in blood lymphocyte subsets

No related papers found yet.

Austria, Bulgaria, Czechia, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Slovakia