At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 312 enrolled
Drug / intervention
ALX-0061 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating ALX-0061 and Placebo for Lupus Erythematosus, Systemic. Completed, enrolled 312 participants across 118 sites in 17 countries.
Detailed Summary
Primary objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared to placebo. Secondary objectives: To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Erythematosus, Systemic
CountriesArgentina, Chile, Czechia, Germany, Hungary, Mexico, Peru, Philippines, Poland, Portugal, Russia, Serbia, South Korea, Spain, Taiwan, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJul 2015
Primary CompletionJan 2018
TodayJul 2026
First PostedMay 8, 2015
Enrollment StartJul 1, 2015
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.2 years ago
Interventions
ALX-0061biological
Placebobiological