A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Conditions

Ulcerative colitis

Brief summary

Efficacy Endpoints: • Proportion of patients in clinical remission. • Proportion of patients with a clinical response • Proportion of patients with endoscopic improvement • Proportion of patients with mucosal healing • Proportion of patients with corticosteroid-free remission • Change from Baseline in complete Mayo score, partial Mayo score, and 9-point Mayo score • Proportion of patients with histologic remission • Proportion of patients with clinical response, clinical remission, or endoscopic, Safety Endpoints: - The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious AEs (SAEs), TEAEs leading to discontinuation of investigational drug, AEs of special interest (AESIs), and TEAEs of special interest will be summarized. - Exploratory safety endpoints include changes from baseline for clinical laboratory measures, vital signs, ECGs, and pulmonary function tests.

Detailed description

Not applicable

Related papers

No related papers found yet.

Interventions

DRUGOzanimod

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Efficacy Endpoints: • Proportion of patients in clinical remission. • Proportion of patients with a clinical response • Proportion of patients with endoscopic improvement • Proportion of patients with mucosal healing • Proportion of patients with corticosteroid-free remission • Change from Baseline in complete Mayo score, partial Mayo score, and 9-point Mayo score • Proportion of patients with histologic remission • Proportion of patients with clinical response, clinical remission, or endoscopic, Safety Endpoints: - The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious AEs (SAEs), TEAEs leading to discontinuation of investigational drug, AEs of special interest (AESIs), and TEAEs of special interest will be summarized. - Exploratory safety endpoints include changes from baseline for clinical laboratory measures, vital signs, ECGs, and pulmonary function tests.	—

Measure

Time frame

Efficacy Endpoints: • Proportion of patients in clinical remission. • Proportion of patients with a clinical response • Proportion of patients with endoscopic improvement • Proportion of patients with mucosal healing • Proportion of patients with corticosteroid-free remission • Change from Baseline in complete Mayo score, partial Mayo score, and 9-point Mayo score • Proportion of patients with histologic remission • Proportion of patients with clinical response, clinical remission, or endoscopic, Safety Endpoints: - The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious AEs (SAEs), TEAEs leading to discontinuation of investigational drug, AEs of special interest (AESIs), and TEAEs of special interest will be summarized. - Exploratory safety endpoints include changes from baseline for clinical laboratory measures, vital signs, ECGs, and pulmonary function tests.

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Secondary

Measure	Time frame
Not applicable	—

Countries

Belgium, Bulgaria, Czechia, Hungary, Italy, Poland, Romania

Outcome results

None listed