Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

Viatris Innovation GmbH

Status and phase: Completed; Phase 2; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Matching placebo; Drug: Cenerimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT02472795

AC-064A201

Details and patient eligibility

About

International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.

Full description

This multicentre, double-blind, placebo-controlled study will have a staggered approach (Part A and B).

In part A, eligible patients will be randomly assigned (1:1:1:1) to once daily oral administration of cenerimod (0.5, 1, 2 mg) or placebo. After all patients have completed 4 weeks of treatment during part A, an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B.

In part B, additional patients will be randomized (3:1) to once daily oral administration of cenerimod 4 mg or placebo.

All participants will receive study medication for 12 weeks.

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female participants aged 18 to 65 years with established SLE. Participants must have active SLE, Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of at least 2 points for musculoskeletal or mucocutaneous manifestations and history or presence at screening of positive anti-nuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.
• Enrolled participants must be treated with background SLE medications.

Exclusion criteria

• Participants with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, infection and infection risks, history or presence of malignancy, history or presence of bone marrow or solid organ transplantation) or lactating or pregnant women.
• Participants with severe SLE disease or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 5 patient groups, including a placebo group

Cenerimod 0.5 mg (Part A)

Experimental group

Description:

Participants will receive cenerimod 0.5 mg capsules orally once daily for 12 weeks.

Treatment:

Drug: Cenerimod

Cenerimod 1 mg (Part A)

Experimental group

Description:

Participants will receive cenerimod 1 mg capsules orally once daily for 12 weeks.

Treatment:

Drug: Cenerimod

Cenerimod 2 mg (Part A)

Experimental group

Description:

Participants will receive cenerimod 2 mg capsules orally once daily for 12 weeks.

Treatment:

Drug: Cenerimod

Cenerimod 4 mg (Part B)

Experimental group

Description:

Participants will received cenerimod 4 mg capsules orally once daily for 12 weeks. This treatment arm will start after all patients in Part A have completed 4 weeks of placebo, 0.5 mg, 1 mg and 2 mg cenerimod treatment.

Treatment:

Drug: Cenerimod

Matching placebo (Part A and B)

Placebo Comparator group

Description:

Capsules of matching placebo taken orally once daily for 12 weeks.

Treatment:

Drug: Matching placebo