Systemic lupus erythematosus
Conditions
Interventions
Product Code: ACT-334441
Pharmaceutical Form: Capsule, hard
Other descriptive name: ACT-334441
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5,1,2,-4
Pharmaceut
Sponsors
ACTELION Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects aged 18 to 65 years with established SLE. Subjects 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 subjects must be treated with background SLE medications. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects 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. Subjects 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacodynamics of ACT-334441, its safety and tolerability profile in lupus subjects.;Secondary Objective: N.A.;Primary end point(s): • Pharmacodynamic endpoints: Change in total lymphocyte count from baseline to EOT and to each post-baseline assessment • safety endpoints: treatment-emergent AE, SAE, AED ; changes in ECG, SBP, DBP, pulmonary variable; laboratory variables ;Timepoint(s) of evaluation of this end point: during the entire study until EOS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetic and disease activity endpoints;Timepoint(s) of evaluation of this end point: during the entire study until EOS | — |
Countries
Belarus, Bulgaria, Georgia, Russian Federation, Ukraine, United States
Contacts
Public ContactGlobal Medical Information
Actelion Pharmaceuticals Ltd
Outcome results
None listed