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

NCT05688696 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-08-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-29
Primary Completion
2025-08-25
Completion
2026-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05688696 on ClinicalTrials.gov