NCT02537028

MSC2364447C Phase 1b in Systemic Lupus Erythematosus

A Phase Ib Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biological Effect of MSC2364447C in Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is to evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of MSC2364447C administered for 4 weeks in systemic lupus erythematosus subjects (SLE).

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	MSC2364447C	Subjects will be administered with MSC2364447C 25 milligrams orally once daily for 4 weeks.
DRUG	MSC2364447C	Subjects will be administered with MSC2364447C 75 milligrams orally once daily for 4 weeks.
DRUG	Placebo	Subjects will be administered with placebo matching to MSC2364447C orally once daily for 4 weeks.

Timeline

• Start date: 2015-11-30
• Primary completion: 2016-10-04
• Completion: 2016-10-04
• First posted: 2015-09-01
• Last updated: 2017-10-09

Locations

13 sites across 2 countries: United States, Bulgaria