NCT02472795View on ClinicalTrials.gov

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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

June 1, 2015

Primary Completion Date

January 23, 2017

Study Completion Date

February 28, 2017

Conditions
Systemic Lupus Erythematosus
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).

Trial Locations (18)

1612

Investigator Site, Sofia

4000

Investigator Site, Plovdiv

4002

Investigator Site, Plovdiv

21018

Investigator Site, Vinnytsia

21029

Investigator Site, Vinnytsia

33765

Investigator Site, Clearwater

36207

Investigator Site, Anniston

69600

Investigator Site, Zaporizhia

210037

Investigator Site, Vitebsk

214025

Investigator Site, Smolensk

220116

Investigator Site, Minsk

223041

Investigator Site, Minsk

305007

Investigator Site, Kursk

460018

Investigator Site, Orenburg

600023

Investigator Site, Vladimir

644111

Investigator Site, Omsk

650066

Investigator Site, Kemerovo

0186

Investigator Site, Tbilisi

All Listed Sponsors
lead

Viatris Innovation GmbH

INDUSTRY

NCT02472795 - Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter