Trials / Completed
CompletedNCT01972568
Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 306 (actual)
- Sponsor
- EMD Serono · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atacicept 75 milligram (mg) | Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks. |
| DRUG | Atacicept 150 mg | Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks. |
| DRUG | Placebo | Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks. |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2016-04-01
- Completion
- 2016-09-01
- First posted
- 2013-10-30
- Last updated
- 2018-01-02
- Results posted
- 2017-10-26
Locations
138 sites across 18 countries: United States, Argentina, Brazil, Bulgaria, Chile, Czechia, Germany, Italy, Japan, Mexico, Peru, Philippines, Poland, Russia, South Africa, South Korea, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01972568. Inclusion in this directory is not an endorsement.