Trials / Active Not Recruiting
Active Not RecruitingNCT05540327
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants With Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 379 (actual)
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
- Sex
- All
- Age
- 18 Years – 76 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569\_0003 \[NCT05162586\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | M5049 low dose | Participants will receive film-coated tablets of M5049 at a low dose orally, twice a day (BID) for up to 194 weeks. |
| DRUG | M5049 medium dose | Participants will receive film-coated tablets of M5049 at a medium dose orally, BID for up to 194 weeks. |
| DRUG | M5049 high dose | Participants will receive film-coated tablets of M5049 at a high dose orally, BID for up to 194 weeks. |
| DRUG | Placebo | Participants will receive M5049 matching placebo orally, BID for up to 194 weeks. |
Timeline
- Start date
- 2022-09-16
- Primary completion
- 2028-08-12
- Completion
- 2028-08-12
- First posted
- 2022-09-14
- Last updated
- 2026-04-16
Locations
122 sites across 22 countries: United States, Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, Greece, Israel, Japan, Mauritius, Mexico, Moldova, Philippines, Poland, Romania, Serbia, South Africa, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05540327. Inclusion in this directory is not an endorsement.