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COMPLETED
NCT02472795
PHASE1/PHASE2

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

Sponsor: Viatris Innovation GmbH

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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

Investigator Site

Vladimir, Russia

Investigator Site

Vinnytsia, Ukraine

Investigator Site

Vinnytsia, Ukraine

Investigator Site

Zaporizhia, Ukraine