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The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)

NCT05162586 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2025-12-01

Study results available
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Summary

The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE; subacute cutaneous lupus erythematosus \[SCLE\] and/or discoid lupus erythematosus \[DLE\]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. Study Duration: 33 weeks Visit Frequency: every 2 or 4 weeks Enpatoran is not available through an expanded access program.

Conditions

Interventions

DRUG

Enpatoran low dose

Participants will receive film-coated tablets of Enpatoran at a low dose orally, twice daily (BID) up to 24 weeks.

DRUG

Enpatoran medium dose

Participants will receive film-coated tablets of Enpatoran at a medium dose, orally, BID up to 24 weeks.

DRUG

Enpatoran high dose

Participants will receive film-coated tablets of Enpatoran at a high dose, orally, BID up to 24 weeks.

DRUG

Placebo

Participants will receive placebo matched to Enpatoran up to 24 weeks.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono Research & Development Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2024-11-20
Completion
2024-11-20
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 NCT05162586 on ClinicalTrials.gov