Trials / Terminated
TerminatedNCT02975336
A Phase II Study of M2951 in SLE
A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With SLE
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 469 (actual)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Participants received placebo matched to M2951 orally for 52 weeks. |
| DRUG | M2951 | Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks. |
| DRUG | M2951 | Participants received 75 mg of M2951 orally QD for 52 weeks. |
| DRUG | M2951 | Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks. |
| DRUG | M2951 | Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks. |
Timeline
- Start date
- 2017-01-04
- Primary completion
- 2019-11-27
- Completion
- 2020-03-23
- First posted
- 2016-11-29
- Last updated
- 2021-04-12
- Results posted
- 2020-12-17
Locations
157 sites across 19 countries: United States, Argentina, Bulgaria, Chile, Colombia, Germany, Italy, Japan, Malaysia, Mauritius, Mexico, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT02975336. Inclusion in this directory is not an endorsement.