A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus

• Registration Number: JPRN-jRCT2080223900
• Lead Sponsor: Merck Biopharma Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
- SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI greater than or equal to (>=) 4) at Screening Visit
- And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
- Other protocol defined inclusion criteria could apply

Exclusion Criteria

- Subjects are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
- Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)
- Acutely worsened renal function
- Central nervous system SLE
- Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than or equal to (>=) 30 mg daily prednisone equivalent
- Use of injectable corticosteroids, or change in dose of corticosteroids.
- Other protocol defined exclusion criteria could apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified