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Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

NCT03742037 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2025-10-03

Study results available
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Summary

The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).

Conditions

Interventions

DRUG

Cenerimod 0.5 mg

Cenerimod will be supplied as a film-coated tablets at the dose of 0.5 mg

DRUG

Cenerimod 1 mg

Cenerimod will be supplied as a film-coated tablets at the dose of 1 mg

DRUG

Cenerimod 2 mg

Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg

DRUG

Cenerimod 4 mg

Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg

DRUG

Placebo

Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod

DRUG

cenerimod 2 mg (ex-4 mg)

Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg

Sponsors & Collaborators

  • Viatris Innovation GmbH

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Viatris Innovation GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2021-08-31
Completion
2022-08-25
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Chile
  • Czechia
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03742037 on ClinicalTrials.gov