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MSC2364447C Phase 1b in Systemic Lupus Erythematosus

NCT02537028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-10-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono Research & Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-10-04
Completion
2016-10-04

Countries

  • United States
  • Bulgaria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02537028 on ClinicalTrials.gov