Phase 2
N=67
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT02472795 ↗Enrolled (actual)
67
Serious AEs
1.5%
Results posted
Feb 2020
Primary outcome: Primary: Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) — -0.26; -0.96; -0.86; -0.87 10^9 cells/L — p=0.39
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Matching placebo (Drug); Cenerimod (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Viatris Innovation GmbH
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) |
-0.26; -0.96; -0.86; -0.87; -0.33 | 0.39 |
| PRIMARY Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment |
1.37; 1.71; 1.62; 1.88; 1.65; -0.13 | — |
Summary
International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02472795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.