NCT05540327Active, not recruitingPhase 2
The WILLOW LTE study with enpatoran in participants with SCLE, DLE and/or SLE
A Phase 2, 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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 May 2026
Brief summary (registry, in English)
Part 1 and Part 2: To evaluate the long-term safety and tolerability of enpatoran in participants with SCLE, DLE, and/or SLE
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 10 May 2024
- Start date
- 21 Nov 2022
- Lead sponsor
- Merck Healthcare KGaA
- Diseases
- Lupus (SLE)
- NCT number
- NCT05540327
- EU CT number
- 2024-510871-39-00
- EudraCT number
- 2022-000239-21
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 65
- 12 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received LTE prohibited medication during the WILLOW study or after the WILLOW study Week 24
- Participation in any other investigational drug study after the WILLOW study Week 24
Other illness
- Ongoing or active clinically significant viral (including Severe acute arespiratory syndrome coronavirus 2 [(SARS‑CoV‑2)], bacterial or fungal infection, or any major episode of infection requiring hospitalization
Lab values
- Participants who experienced serious event(s) related to the study intervention during the WILLOW study - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Long Term Extension (LTE) study participation
Other
- Other protocol defined exclusion criteria could apply
Who the study is looking for
- Are ≥ 18 and ≤ 76 years of age at the time of signing the informed consent
- Are active SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study
- Have a Body Mass Index (BMI) within the greater than or equal to (>=) 40 kilograms per meter square (inclusive) at Screening
- Participants who had successfully completed Week 48 of the Part 1 will have the opportunity to participate in the LTE Part 2. In exceptional cases and after Sponsor review, participants who have completed the Week 48 visit of the Part 1 within the previous 4-weeks may be considered for Part 2 participation based on eligibility review. Previous 4-weeks will be calculated from the Week 48 visit of Part 1
- Other protocol defined inclusion criteria could apply
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Diagnostics And Consultancy Center Sveti Georgi EOOD Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Dkc Fokus-5 Lzip OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Active, not recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Arensia Clinics S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Delta Health Care S.R.L Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic Colentina Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Saint Maria Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.