A PHASE II, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATETHE SAFETY AND EFFICACY OF M2951 IN SUBJECTS WITHSYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Not Applicable

Recruiting

• Conditions: -M32 Systemic lupus erythematosus; Systemic lupus erythematosus; M32

• Registration Number: PER-004-17
• Lead Sponsor: A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-24
• Study Completion: 2020-07-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Eligible male and female subjects, aged 18 to 75 years; must have diagnosis of SLE with either
the SLICC criteria for SLE, or at least four of the 11 ACR classification criteria for SLE, of at
least six months duration prior to Screening; SLEDAI-2K total score ≥ 6 (including clinical
SLEDAI ≥ 4) at Screening Visit; and be positive for anti-double-stranded DNA and/or
anti-nuclear antibody (ANA ≥ 1:80) at the time of Screening.
Detailed of all inclusion criteria are detailed in Section 5.3.1. of protocol page N° 42

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 ≥ 30 mg daily prednisone equivalent; use of
injectable corticosteroids, or change in dose of corticosteroids.
Detailed of all exclusion criteria are detailed in Section 5.3.2 of protocol page N° 44

Study & Design

• Study Type: Interventional
• Study Design: Not specified