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Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
Sponsor: Viatris Innovation GmbH
Summary
International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2015-06-01
Completion Date
2017-02-28
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
Matching placebo
One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).
Cenerimod
One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).
Locations (18)
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
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Vladimir, Russia
Investigator Site
Vinnytsia, Ukraine
Investigator Site
Vinnytsia, Ukraine
Investigator Site
Zaporizhia, Ukraine