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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT02472795

Run by

Viatris Innovation GmbH

People needed

105

Starts

2015-06-01

Expected to finish

2017-02-28

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigator Site — Anniston, Alabama, United States
• Investigator Site — Clearwater, Florida, United States
• Investigator Site — Minsk, Belarus
• Investigator Site — Minsk, Belarus
• Investigator Site — Vitebsk, Belarus
• Investigator Site — Plovdiv, Bulgaria
• Investigator Site — Plovdiv, Bulgaria
• Investigator Site — Sofia, Bulgaria
• Investigator Site — Tbilisi, Georgia
• Investigator Site — Kemerovo, Russia
• Investigator Site — Kursk, Russia
• Investigator Site — Omsk, Russia
• Investigator Site — Orenburg, Russia
• Investigator Site — Smolensk, Russia
• Investigator Site — Vladimir, Russia
• Investigator Site — Vinnytsia, Ukraine
• Investigator Site — Vinnytsia, Ukraine
• Investigator Site — Zaporizhia, Ukraine

Full record on ClinicalTrials.gov

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