Trials / Completed
CompletedNCT02437890
A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 312 (actual)
- Sponsor
- Ablynx, a Sanofi company · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALX-0061 | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2018-01-01
- Completion
- 2018-01-01
- First posted
- 2015-05-08
- Last updated
- 2019-02-26
- Results posted
- 2019-02-06
Locations
118 sites across 17 countries: United States, Argentina, Chile, Czechia, Germany, Hungary, Mexico, Peru, Philippines, Poland, Portugal, Russia, Serbia, South Korea, Spain, Taiwan, Ukraine
Source: ClinicalTrials.gov record NCT02437890. Inclusion in this directory is not an endorsement.