International clinical trial to evaluate the biological activity and safety of ACT-334441 in lupus

• Register: EUCTR
• Last refreshed on: 8 May 2017
• Main ID: EUCTR2014-002984-14-BG
• Date of registration: 11/05/2015
• Prospective Registration: Yes
• Primary sponsor: ACTELION Pharmaceuticals Ltd
• Public title: International clinical trial to evaluate the biological activity and safety of ACT-334441 in lupus
• 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: 05/06/2015
• Target sample size: 64
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002984-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Global Medical Information
• Affiliation: Actelion Pharmaceuticals Ltd

• Name: Global Medical Information
• Affiliation: Actelion Pharmaceuticals Ltd

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic lupus erythematosus

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

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

Main Objective: To assess the pharmacodynamics of ACT-334441, its safety and tolerability profile in lupus subjects.

Secondary Objective: N.A.

Timepoint(s) of evaluation of this end point: during the entire study until EOS

Secondary Outcome(s)

Secondary end point(s): Pharmacokinetic and disease activity endpoints

Timepoint(s) of evaluation of this end point: during the entire study until EOS

Secondary ID(s)

AC-064A201

Source(s) of Monetary Support

ACTELION Pharmaceuticals Ltd