A Phase II Study of M2951 in SLE

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: M2951; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02975336

MS200527-0018

2016-002950-19 (EudraCT Number)

Details and patient eligibility

About

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

Enrollment: 469 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible male and female participants, aged 18 to 75 years
• 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

• Participants 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 (>) 30 mg daily prednisone equivalent
• Use of injectable corticosteroids, or change in dose of corticosteroids.
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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469 participants in 8 patient groups, including a placebo group

Double-Blind Placebo-Controlled (DBPC) Period: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

DBPC Period: M2951 25 mg QD

Experimental group

Treatment:

Drug: M2951

Drug: M2951

Drug: M2951

Drug: M2951

DBPC Period: M2951 75 mg QD

Experimental group

Treatment:

Drug: M2951

Drug: M2951

Drug: M2951

Drug: M2951

DBPC Period: M2951 50 mg BID

Experimental group

Treatment:

Drug: M2951

Drug: M2951

Drug: M2951

Drug: M2951

Long-Term Extension (LTE) Period: Placebo/ M2951 50 mg BID

Experimental group

Treatment:

Drug: M2951

Drug: M2951

Drug: M2951

Drug: M2951

LTE Period: M2951 25 mg QD/ M2951 50 mg BID

Experimental group

Treatment:

Drug: M2951

Drug: M2951

Drug: M2951

Drug: M2951

LTE Period: M2951 75 mg QD/ M2951 50 mg BID

Experimental group

Treatment:

Drug: M2951

Drug: M2951

Drug: M2951

Drug: M2951

LTE Period: M2951 50 mg BID/ M2951 50 mg BID

Experimental group

Treatment:

Drug: M2951

Drug: M2951

Drug: M2951

Drug: M2951