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

NCT02472795 | Completed Phase 1 Results DMC

• 1 other identifier: AC-064A201
• Study Type: interventional
• Target: 105
• Locations: 6 countries
• Sites: 18

Brief Summary

International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus

Outcome Measures

Primary Outcomes (2)

• Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)

  The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.

  Baseline to end-of-treatment (EOT) (up to 12 weeks)

• Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment

  The primary objective of the clinical study was to assess whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at visit minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.

  Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks)

Study Arms (5)

Cenerimod 0.5 mg (Part A)

EXPERIMENTAL

Participants will receive cenerimod 0.5 mg capsules orally once daily for 12 weeks.

Drug: Cenerimod

Cenerimod 1 mg (Part A)

EXPERIMENTAL

Participants will receive cenerimod 1 mg capsules orally once daily for 12 weeks.

Drug: Cenerimod

Cenerimod 2 mg (Part A)

EXPERIMENTAL

Participants will receive cenerimod 2 mg capsules orally once daily for 12 weeks.

Drug: Cenerimod

Cenerimod 4 mg (Part B)

EXPERIMENTAL

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.

Drug: Cenerimod

Matching placebo (Part A and B)

PLACEBO COMPARATOR

Capsules of matching placebo taken orally once daily for 12 weeks.

Drug: Matching placebo

Interventions

Matching placebo DRUG

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).

Also known as: Placebo

Matching placebo (Part A and B)

Cenerimod DRUG

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).

Also known as: ACT-334441

Cenerimod 0.5 mg (Part A); Cenerimod 1 mg (Part A); Cenerimod 2 mg (Part A); Cenerimod 4 mg (Part B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged 18 to 65 years with established SLE. Participants must have active SLE, Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of at least 2 points for musculoskeletal or mucocutaneous manifestations and history or presence at screening of positive anti-nuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.
• Enrolled participants must be treated with background SLE medications.

You may not qualify if:

• Participants with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, infection and infection risks, history or presence of malignancy, history or presence of bone marrow or solid organ transplantation) or lactating or pregnant women.
• 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.

Sponsors & Collaborators

• Viatris Innovation GmbH: lead

Study Sites (18)

Investigator Site

Anniston, Alabama, 36207, United States

Location

Investigator Site

Clearwater, Florida, 33765, United States

Location

Investigator Site

Minsk, 220116, Belarus

Location

Investigator Site

Minsk, 223041, Belarus

Location

Investigator Site

Vitebsk, 210037, Belarus

Location

Investigator Site

Plovdiv, 4000, Bulgaria

Location

Investigator Site

Plovdiv, 4002, Bulgaria

Location

Investigator Site

Sofia, 1612, Bulgaria

Location

Investigator Site

Tbilisi, 0186, Georgia

Location

Investigator Site

Kemerovo, 650066, Russia

Location

Investigator Site

Kursk, 305007, Russia

Location

Investigator Site

Omsk, 644111, Russia

Location

Investigator Site

Orenburg, 460018, Russia

Location

Investigator Site

Smolensk, 214025, Russia

Location

Investigator Site

Vladimir, 600023, Russia

Location

Investigator Site

Vinnytsia, 21018, Ukraine

Location

Investigator Site

Vinnytsia, 21029, Ukraine

Location

Investigator Site

Zaporizhia, 69600, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 31798918 RESULT

Related Links

• 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.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

cenerimod

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

This study is the first to investigate short-term cenerimod treatment in patients with mild to moderate systemic lupus erythematosus (SLE).

Results Point of Contact

• Title: Viatris Innovation Clinical Trial Information
• Organization: Viatris Innovation GmbH

viatrisinnovationclinicaltrials@viatris.com

+1 908 435 2675

Study Officials

• Clinical Trials

  Viatris Innovation GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: June 16, 2015
• Study Start: June 1, 2015
• Primary Completion: January 23, 2017
• Study Completion: February 28, 2017
• Last Updated: October 3, 2025
• Results First Posted: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BU (3); RU (6); GE (1); US (2); UA (3); BE (3)