NCT05688696

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus

A Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are receiving standard of care (SOC) therapy.

Conditions

• Systemic Lupus Erythematosus, SLE

Interventions

Type	Name	Description
DRUG	Orelabrutinib (Low Dose)	Subjects will be administered with lower dose of Orelabrutinib orally once daily in combination with SOC therapy
DRUG	Orelabrutinib (High Dose)	Subjects will be administered with higher dose of Orelabrutinib orally once daily in combination with SOC therapy
DRUG	Orelabrutinib Placebo	Subjects will be administered with Orelabrutinib Placebo orally once daily in combination with SOC therapy

Timeline

• Start date: 2023-04-29
• Primary completion: 2025-08-25
• Completion: 2026-05-30
• First posted: 2023-01-18
• Last updated: 2024-08-16

Locations

41 sites across 1 country: China