A Phase II Study of M2951 in SLE

Phase 1

• Conditions: Systemic Lupus Erythematosus (SLE); MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-002950-19-DE
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-12
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 468

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 and have positive test results for anti doublestranded DNA (anti-dsDNA) antibody and/or anti nuclear antibody (human epithelial cell-2 ANA = 1:80) and/or anti-Smith (anti Sm) antibody at the time of Screening.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 464
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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;
active central nervous system SLE (to be severe or progressive including history of transverse myelitis, seizures,
and/or associated with significant cognitive impairment);
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified