Telitacicept for Lupus

Recruiting in Palo Alto (17 mi)

+99 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: RemeGen Co., Ltd.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing telitacicept, a protein that helps reduce overactive immune cells, in patients with active lupus who don't respond well to standard treatments. It works by blocking proteins that help immune cells grow, which can reduce lupus symptoms. Telitacicept is a new treatment that has been approved in China for adults with active lupus.

Eligibility Criteria

This trial is for people with moderately to severely active Systemic Lupus Erythematosus (SLE). Participants must have an hSLEDAI score of ≥ 4, a positive serologic test, and be on standard SLE medications like steroids or antimalarials. They should have been diagnosed with SLE at least 6 months ago. Those with recent infections, cancer history within 5 years, severe lupus complications or other autoimmune diseases can't join.

Inclusion Criteria

I have active lupus with a score indicating moderate to severe disease and am on standard treatment.

I have been diagnosed with lupus for at least 6 months.

Exclusion Criteria

I do not have any severe or active infections.

I have had cancer within the last 5 years.

Other protocol defined exclusion criteria may apply

+3 more

Participant Groups

The REMESLE-1 study is testing the effectiveness and safety of Telitacicept in treating SLE. Patients will either receive Telitacicept or a placebo without knowing which one they're getting. The goal is to see if Telitacicept can better manage the symptoms compared to not receiving the active drug.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TelitaciceptExperimental Treatment1 Intervention

Telitacicept + Standard of Care (SoC)

Group II: PlaceboPlacebo Group1 Intervention

Placebo + Standard of Care (SoC)