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

Beijing InnoCare Pharma Tech Co., Ltd.41 sites in 1 country186 target enrollmentApril 29, 2023

ConditionsSystemic Lupus Erythematosus, SLE

InterventionsOrelabrutinib (Low Dose)Orelabrutinib (High Dose)Orelabrutinib Placebo

DrugsOrelabrutinib (Low Dose)Orelabrutinib (High Dose)Orelabrutinib Placebo

Overview

Phase: Phase 2
Intervention: Orelabrutinib (Low Dose)
Conditions: Systemic Lupus Erythematosus, SLE
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment: 186
Locations: 41
Primary Endpoint: SLE Responder Index (SRI) - 4 response rate
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 29, 2023

End Date

May 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•have had a detailed understanding of the nature, significance, potential benefits, potential risks, and procedures of the study, and voluntarily signed a written Informed Consent Form (ICF).
•Males or females aged≥18 and ≤75 years.
•Have a clinical diagnosis of SLE 6 months prior to signing the ICF, meeting at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
•SLEDAI-2K≥8 at screening.
•Are on a stable SLE SOC therapy consisting of any of the following medications for a period of at least 30 days prior to the first dose: glucocorticoid, and/or anti-malarials, and/or immunosuppressive agents.
•Have a positive test for anti-dsDNA antibody (\> normal range) and/or anti-nuclear antibody (ANA) and/or anti-Smith antibody at screening.
•Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational agent. In this trial.

Exclusion Criteria

•Medical conditions:
•Pregnant or lactating women, and men or women who have birth plans in the past 12 months.
•Have neuropsychiatric systemic lupus erythematosus (NPSLE) within 6 months prior to the first dose, including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cranial neuropathy, cerebritis, cerebral vasculitis or lupus headache.
•Have severe lupus nephritis, or have required hemodialysis or high-dose glucocorticoid within 90 days prior to the first dose.
•Have autoimmune diseases other than SLE (excluding secondary Sjogren's syndrome).
•Have a history of any non-SLE disease that has required treatment with oral or intravenous or intramuscular or subcutaneous injection glucocorticoids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
•Have a history of or current diagnosis of Central Nervous System (CNS) diseases.
•Have clinically documented cardiovascular diseases that are obviously unstable or not effectively treated.
•Have significant active lung diseases (e.g., interstitial lung disease, obstructive pulmonary disease).
•Have severe hepatobiliary diseases.

Arms & Interventions

Orelabrutinib Lower Dose

Intervention: Orelabrutinib (Low Dose)

Orelabrutinib Higher Dose

Intervention: Orelabrutinib (High Dose)

Placebo

Intervention: Orelabrutinib Placebo

Outcomes

Primary Outcomes

SLE Responder Index (SRI) - 4 response rate

Time Frame: Week 48

SRI-4 response is defined as: 1)≥4 point reduction from baseline in SLE disease activity index-2000 (SLEDAI-2K) score; 2) no worsening (increase of \<0.3 points from baseline) in Physician's Global Assessment (PGA); 3) no new A organ domain score or no more than 1 new B organ domain scores compared with baseline in British Isles Lupus Assessment Group (BILAG)-2004.

Secondary Outcomes

British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rate(Week 48)
SLE Responder Index (SRI) - 6 response rate(Week 48)
Time to 1st flare(Week 48)
The proportion of subjects whose average prednisone dose has been reduced by≥25% from baseline to ≤7.5 mg/day(Week 48)
Changes from baseline in the levels of complement C3, complement C4, and anti-dsDNA antibody(Week 48)
Treatment Emergent Adverse Events, Treatment Related Adverse Events, Treatment Emergent Serious Adverse Events, Treatment Related Serious Adverse Events.(Up to Week 52)
Mean change from baseline in the 36-Item Short Form Health Survey (SF-36) scores (The SF-36 consists of eight domains. Each domain score ranges from 0-100. The higher the score, the better the health. )(Week 48)