A Phase 3 Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus

• Status: Not yet recruiting
• Trial end date: 2025-09-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RemeGen Co., Ltd.
• Collaborator: Iqvia Pty Ltd

Criteria

Inclusion Criteria:

1. Has had a diagnosis of SLE for at least 6 months prior to the screening Visit.

2. Moderate to severely active SLE is defined by the following:

1. Hybrid SELENA SLEDAI (hSLEDAI) total score ≥ 6 at screening with clinical hSLEDAI score ≥ 4 points

2. BILAG-2004 organ system scores of at least 1 A or 2 B at screening.

3. Clinical hSLEDAI score of ≥ 4 at Day 0 prior to randomization

4. At least one positive serologic parameter within the screening period

5. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

6. Other protocol defined inclusion criteria may apply.

Exclusion Criteria:

1. Active or unstable neuropsychiatric SLE or lupus nephritis

2. Autoimmune or rheumatic disease other than SLE

3. Significant, uncontrolled medical conditions not related to SLE

4. Active and/or severe viral, bacterial or fungal infection

5. History of malignancy within 5 years

6. Other protocol defined exclusion criteria may apply.