NCT04711148

A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-Blind, placebo-controlled Phase 2 Study of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis.

Detailed description

The study contains 2 parts: Core Part and an Open-label Extension (OLE) Part. The Core Part is a randomized, double-blind, placebo-controlled, phase 2 study. Patients with RRMS will be randomly assigned to 1 of 4 treatment groups. placebo, orelabrutinib (low dose), orelabrutinib (medium dose) and orelabrutinib (high dose) at a 1:1:1:1 ratio. The OLE part is an open-label, single treatment arm study to enroll patients who have completed the Week 24 visit in the Core Part for continued treatment and collect additional long-term safety and efficacy data.All patients will receive the low dose of orelabrutinib or any other dose as suggested from the Core part of the study.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	placebo	placebo
DRUG	orelabrutinib	Orelabrutinib is a white, round, uncoated tablet

Timeline

• Start date: 2021-03-01
• Primary completion: 2026-02-25
• Completion: 2026-03-01
• First posted: 2021-01-15
• Last updated: 2023-04-21

Locations

42 sites across 4 countries: United States, China, Poland, Ukraine

Regulatory

• FDA-regulated drug study