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

NCT05540327 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 379

Last updated 2026-04-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-16
Primary Completion
2028-08-12
Completion
2028-08-12
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05540327 on ClinicalTrials.gov