Study of M5049 in CLE and SLE Participants

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Cutaneous Lupus Erythematosus; Systemic Lupus Erythematosus

Treatments: Drug: M5049; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04647708

2020-003118-11 (EudraCT Number)

MS200569_0004

Details and patient eligibility

About

This study is to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered M5049 in participants with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE).

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active systemic lupus erythematosus (SLE) with a Cutaneous lupus erythematosus disease area and activity index (CLASI-A) greater than or equal to [>= ] 6 and/or at least one active SLE clinical manifestation according to Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
• Active cutaneous lupus erythematosus (CLE) (subacute cutaneous lupus erythematosus and/or discoid lupus erythematosus) with a CLASI-A >= 6
• Other protocol defined inclusion criteria could apply

Exclusion criteria

• Autoimmune or rheumatic disease other than SLE or CLE
• Dermatological diseases other than cutaneous manifestations of SLE or CLE
• Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
• Ongoing or active clinically significant viral, bacterial or fungal infection
• History of uncontrolled seizures or other neurological disorder
• History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
• History of malignancy
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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25 participants in 7 patient groups, including a placebo group

Part A (Cohort 1): M5049 Dose A

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049

Part A (Cohort 2): M5049 Dose B

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049

Part A (Cohort 3): M5049 Dose C

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049

Part A (Cohort 4): M5049 Dose D

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049

Part A: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Part B (Cohort 5): M5049 Dose E

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049

Part B: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo