Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
NCT ID: NCT02472795
Last Updated: 2025-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
105 participants
INTERVENTIONAL
2015-06-01
2017-02-28
Brief Summary
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Detailed Description
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In part A, eligible patients will be randomly assigned (1:1:1:1) to once daily oral administration of cenerimod (0.5, 1, 2 mg) or placebo. After all patients have completed 4 weeks of treatment during part A, an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B.
In part B, additional patients will be randomized (3:1) to once daily oral administration of cenerimod 4 mg or placebo.
All participants will receive study medication for 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cenerimod 0.5 mg (Part A)
Participants will receive cenerimod 0.5 mg capsules orally once daily for 12 weeks.
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).
Cenerimod 1 mg (Part A)
Participants will receive cenerimod 1 mg capsules orally once daily for 12 weeks.
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).
Cenerimod 2 mg (Part A)
Participants will receive cenerimod 2 mg capsules orally once daily for 12 weeks.
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).
Cenerimod 4 mg (Part B)
Participants will received cenerimod 4 mg capsules orally once daily for 12 weeks. This treatment arm will start after all patients in Part A have completed 4 weeks of placebo, 0.5 mg, 1 mg and 2 mg cenerimod treatment.
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).
Matching placebo (Part A and B)
Capsules of matching placebo taken orally once daily for 12 weeks.
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).
Interventions
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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).
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Enrolled participants must be treated with background SLE medications.
Exclusion Criteria
* Participants with severe SLE disease or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study.
18 Years
65 Years
ALL
No
Sponsors
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Viatris Innovation GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Viatris Innovation GmbH
Locations
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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
Countries
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References
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Hermann V, Batalov A, Smakotina S, Juif PE, Cornelisse P. First use of cenerimod, a selective S1P1 receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. Lupus Sci Med. 2019 Nov 9;6(1):e000354. doi: 10.1136/lupus-2019-000354. eCollection 2019.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Lay summary on results reference by Hermann V et al. First use of cenerimod, a selective S1P(1) receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. Lupus Sci Med. 2019 Nov 9;6(1):e000354.
Other Identifiers
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AC-064A201
Identifier Type: -
Identifier Source: org_study_id
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