The Efficacy and Safety of Oral Etrasimod as Therapy for Moderately to Severely Active Crohn's Disease

Crohn Disease Clinical Trial

Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Status Not yet recruiting

Clinical Trial Summary

Objectives:

Primary Objectives Substudy A - Phase 2

• To evaluate the safety, tolerability, and efficacy of 2 doses of etrasimod as induction therapy in subjects with moderately to severely active Crohn's disease (CD) Substudy 1 - Phase 2b

• To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active CD

• To select an oral etrasimod dose(s), based on efficacy and safety, for continued development Substudy 2 - Induction (Phase 3)

• To evaluate the efficacy of the selected etrasimod dose versus placebo as induction therapy in subjects with moderately to severely active CD Substudy 3 - Maintenance (Phase 3)

• To evaluate the efficacy of etrasimod versus placebo as maintenance therapy in subjects with moderately to severely active CD Substudy 4 - Long-Term Extension

• To evaluate the long-term safety and tolerability of etrasimod in subjects with moderately to severely active CD Secondary Objectives Substudy A - Phase 2

• To evaluate the long-term safety, tolerability, and efficacy of etrasimod in subjects with moderately to severely active CD

• To evaluate the pharmacokinetic (PK) and pharmacodynamic effects of etrasimod as induction and maintenance therapy, including changes in lymphocytes, C-reactive protein (CRP), and fecal calprotectin (FCP) in subjects with moderately to severely active CDSubstudy 1 - Phase 2b

• To evaluate the long-term safety, tolerability, and efficacy of etrasimod in subjects with moderately to severely active CD

• To provide a subset of the target study population, etrasimod responders, to be evaluated in Substudy 3 - Maintenance Substudy 2 - Induction (Phase 3)

• To evaluate the safety and tolerability of the selected etrasimod Phase 3 dose (3 mg or 2 mg) versus placebo as induction therapy in subjects with moderately to severely active CD

• To provide a subset of the target study population, etrasimod responders, to be evaluated in Substudy 3 - Maintenance Substudy 3 - Maintenance (Phase 3)

• To evaluate the efficacy of etrasimod on sustained clinical remission and endoscopic response, endoscopic remission, and corticosteroid-free clinical remission in subjects with moderately to severely active CD

• To characterize the safety and tolerability of etrasimod as maintenance therapy in subjects with moderately to severely active CD Substudy 4 - Long-Term Extension

• To evaluate the long-term efficacy of etrasimod in subjects with moderately to severely active CD

Clinical Trial Description

This is a seamless Phase 2/3, multicenter, randomized, double-blind, study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of etrasimod as therapy in subjects with moderately to severely active CD who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). Subjects who are refractory or intolerant to corticosteroids and/or immunosuppressants may be either previously exposed to or naïve to biologics. Randomized subjects will remain on stable doses of 5-aminosalicyclic acid compounds, low-dose oral corticosteroids, and/or anti-diarrheal medications as background therapy for CD; however, corticosteroid tapering may be required in subjects who continue treatment beyond the Induction Period. The 5 substudies are presented in the study schematic and described below.

Substudy A - Phase 2 (SSA-P2): A Phase 2, randomized, double-blind, substudy to assess the safety, tolerability, and efficacy of oral etrasimod therapy in subjects with moderate to severe CD that supports the selection of an induction and maintenance dose(s) for Phase 3. Substudy 1 - Phase 2 (SS1-P2b): A Phase 2b randomized, double-blind, placebo-controlled, dose-ranging induction substudy to evaluate etrasimod as induction therapy and select an induction and maintenance dose(s) for continued evaluation in Phase 3. Substudy 2 - Induction (SS2-I): A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as induction therapy. Substudy 3 - Maintenance (SS3-M): A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as maintenance therapy. Substudy 4 - Long-Term Extension (SS4-E): A long-term extension (LTE) substudy for subjects who complete at least 52 weeks of treatment. ;

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT05033340
• Study type: Interventional
• Source: Theodor Bilharz Research Institute
• Contact: samia H El-Shishtawy, ASS. PROF
• Phone: 01003661563
• Email: crc.tbri@gmail.com
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2021
• Completion date: August 31, 2025