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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02472795
• Date of registration: 14/05/2015
• Prospective Registration: Yes
• Primary sponsor: Idorsia Pharmaceuticals Ltd.
• Public title: Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
• Date of first enrolment: June 1, 2015
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02472795
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Belarus, Bulgaria, Georgia, Russian Federation, Ukraine, United States

Contacts

• Name: Study Director
• Affiliation: Idorsia Pharmaceuticals Ltd.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Matching placebo

Drug: Cenerimod

Primary Outcome(s)

Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks)]

Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) [Time Frame: Baseline to end-of-treatment (EOT) (up to 12 weeks)]

Secondary ID(s)

AC-064A201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02472795