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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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Diagnostics And Consultancy Center Sveti Georgi EOOD
Coordinator of this site? Confirm its status
HaskovoBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
Dkc Fokus-5 Lzip OOD
Coordinator of this site? Confirm its status
SofiyaBulgariaActive, not recruiting
Complexo Hospitalario Universitario A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainActive, not recruiting
Hospital Universitario Regional de Málaga
Coordinator of this site? Confirm its status
MálagaSpainActive, not recruiting
Laiko General Hospital of Athens
Coordinator of this site? Confirm its status
AthensGreeceActive, not recruiting
General Hospital Of Thessaloniki Papageorgiou
Coordinator of this site? Confirm its status
EfkarpiaGreeceActive, not recruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Coordinator of this site? Confirm its status
CracowPolandActive, not recruiting
Arensia Clinics S.R.L.
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting
Delta Health Care S.R.L
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting
Spitalul Clinic Colentina Bucuresti
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting
Saint Maria Hospital
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.