The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

NCT05540327
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
379
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Lead sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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Start date
2022-09-16
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Number of sites
122
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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 \[NCT05162586\]).
clinicaltrials.gov
Short title
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
clinicaltrials.gov
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)
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-08-12
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First posted
2022-09-14
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Registry last updated
2026-07-20
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Primary completion date
2028-08-12
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Start date
2022-09-16
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Actual participants
379
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Participants
379
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
122
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05540327
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ClinicalTrials.gov ID
NCT05540327
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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))

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
76 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Other registry identifiers

  • 2022-000239-21
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (2)