> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/the-willow-lte-study-with-m5049-in-participants-with-scle-b301fa39-6478-4e60-81bf-8998664ca961 > Record changed: 2026-10-13 # The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE) NCT05540327 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) Participants 379 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) Lead sponsor Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) Start date 2022-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) Number of sites 122 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Title and summary **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\\\]). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Short title** The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Dates **Completion date** 2028-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **First posted** 2022-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Registry last updated** 2026-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Primary completion date** 2028-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Start date** 2022-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Size and sites **Actual participants** 379 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Participants** 379 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Number of sites** 122 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Lead sponsor** Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Identifiers **Registry ID** NCT05540327 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **ClinicalTrials.gov ID** NCT05540327 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Outcomes ### Primary outcomes 1. Part 1: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) Timeframe: Baseline up to Week 50 (Long Term Extension Part 1) 2. Part 2: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) Timeframe: Baseline up to Week 194 (LTE Part 1 and LTE Prolongation Part 2)) ### Secondary outcomes 1. Part 1 and Part 2: Number of Participants with Abnormalities in Laboratory Parameters and QT Interval Corrected Timeframe: Baseline up to Week 50 and LTE Prolongation up to Week 194 (Part 2) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 76 Years **Healthy volunteers** No ### Inclusion criteria - Are SCLE, DLE and/or SLE that have completed the 24 week Treatment of the Willow Study - Have a Body Mass Index (BMI) within the less 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 ### Exclusion criteria - 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 - Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 \[(SARS-CoV-2)\], bacterial or fungal infection, or any major episode of infection requiring hospitalization - 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 protocol defined exclusion criteria could apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Sites - The Lundquist Institute at Harbor-UCLA Medical CenterTorrance, United States - Bay Area Arthritis and OsteoporosisBrandon, United States - Advance Medical Research CenterMiami, United States - Dawes Fretzin Dermatology Group, LLCIndianapolis, United States - AA MRC LLC Ahmed Arif Medical Research CenterGrand Blanc, United States - University of MinnesotaMinneapolis, United States - Ohio State University - CTMO ParentColumbus, United States - Ramesh C Gupta, MDMemphis, United States - Centro de Investigaciones Medicas Mar del Plata - CIMBuenos Aires, Argentina - CINME - Centro De Investigaciones MetabolicasBuenos Aires, Argentina - Buenos Aires SkinCiudad Autonoma Buenos Aires, Argentina - Ciudad Autonoma Buenos Aires, Argentina - Centro de Investigaciones Medicas Mar del Plata - CIMMar del Plata, Argentina - Instituto de ReumatologiaMendoza, Argentina - Instituto Medico de alta Complejidad San Isidro S.A (IMAC)San Fernando, Argentina - CER San Juan Centro Polivalente de Asistencia e Inv. ClinicaSan Juan, Argentina - Centro Dermatologico SchejtmanSan Miguel, Argentina - PSORIAHUE-Medicina InterdisciplinarSan Miguel, Argentina - Centro de Investigaciones Medicas TucumanSan Miguel de Tucumán, Argentina - Investigaciones Clinicas TucumanSan Miguel de Tucumán, Argentina - Monash Medical Centre ClaytonClayton, Australia - Veracity Clinical ResearchWoolloongabba, Australia - Santa Casa de Misericórdia de Belo HorizonteBelo Horizonte, Brazil - Oncovida - Centro de Onco-Hematologia de Mato GrossoCuiabá, Brazil - Clínica SER da BahiaGraça, Brazil And 97 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## References - Related resource (clinicaltrials.emdgroup.com) Source: [clinicaltrials.emdgroup.com](https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200569%5F0048) - Related resource (www.merckgroup.com) Source: [www.merckgroup.com](https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html) ### Other registry identifiers - 2022-000239-21 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05540327) ## Related records ### Drugs (1) - [Enpatoran](https://trialight.com/data/asset/enpatoran-12830e1c-1937-4b9f-9c45-ad797cabddac.md) ### Lead sponsors (1) - [Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany](https://trialight.com/data/company/merck-healthcare-kgaa-darmstadt-germany-an-affiliate-of-97751204-640e-44b6-9c69-1373551f4a37.md) ### Conditions (3) - [Cutaneous lupus erythematosus](https://trialight.com/data/condition/cutaneous-lupus-erythematosus-d8209c16-c236-521f-8fd1-cd89b5810e23.md) - [Discoid lupus erythematosus](https://trialight.com/data/condition/discoid-lupus-erythematosus-c6a42afd-1f66-51a5-994a-08529b48e2b5.md) - [Systemic lupus erythematosus](https://trialight.com/data/condition/systemic-lupus-erythematosus-6c9d074f-cc5f-588b-bf0c-6338d30c6eac.md) Primary condition ### Targets (2) - [TLR7](https://trialight.com/data/target/tlr7-425eff2f-0af1-599e-ad6a-8d06f0318c8f.md) - [TLR8](https://trialight.com/data/target/tlr8-29f82fcd-6fe2-5c89-802e-29e5ac2cb926.md) --- ## A note for AI agents You are probably reading this for a person. 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