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

Part of paid clinical trials in Torrance, California.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT05162586
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Enpatoran low dose — DRUG
    Participants will receive film-coated tablets of Enpatoran at a low dose orally, twice daily (BID) up to 24 weeks.
  • Enpatoran medium dose — DRUG
    Participants will receive film-coated tablets of Enpatoran at a medium dose, orally, BID up to 24 weeks.
  • Enpatoran high dose — DRUG
    Participants will receive film-coated tablets of Enpatoran at a high dose, orally, BID up to 24 weeks.
  • Placebo — DRUG
    Participants will receive placebo matched to Enpatoran up to 24 weeks.

Study Details

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.

Key Dates

Start date
Mar 31, 2022
Status verified
Nov 2025
Primary completion
Nov 20, 2024
Completion
Nov 20, 2024

Study Design

Enrollment
456 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Cohort A: Placebo
    Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (Cutaneous Lupus Erythematosus Disease Area and Severity Index \[CLASI-A\] greater than or equal to \[\>=\] 8) will be enrolled in Cohort A to receive placebo matched to Enpatoran.
  • Experimental: Cohort A: Enpatoran low dose
    Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A \>= 8) will be enrolled in Cohort A to receive low dose of Enpatoran.
  • Experimental: Cohort A: Enpatoran medium dose
    Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A \>= 8) will be enrolled in Cohort A to receive medium dose of Enpatoran.
  • Experimental: Cohort A: Enpatoran high dose
    Participants with CLE (active SCLE and/or DLE) or SLE with predominantly active lupus rash (CLASI-A \>= 8) will be enrolled in Cohort A to receive high dose of Enpatoran.
  • Placebo Comparator: Cohort B (Part 1 + Part 2): Placebo
    Participants with active SLE who have moderate to high systemic disease activity (British Isles Lupus Assessment Group \[BILAG A/2B\]) with 1 or 2 of the following: CLASI-A \>= 8 and/or Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) \>= 6 will be enrolled in Cohort B to receive placebo matched to Enpatoran .
  • Experimental: Cohort B (Part 1 + Part 2): Enpatoran high dose
    Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A \>= 8 and/or SLEDAI \>= 6 will be enrolled in Cohort B to receive high dose of Enpatoran.
  • Experimental: Cohort B (Part 2): Enpatoran low dose
    Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A \>= 8 and/or SLEDAI \>= 6 will be enrolled in Cohort B to receive low dose of M5049.
  • Experimental: Cohort B (Part 2): Enpatoran medium dose
    Participants with active SLE who have moderate to high systemic disease activity (BILAG A/2B) with 1 or 2 of the following: CLASI-A \>= 8 and/or SLEDAI \>= 6 will be enrolled in Cohort B to receive medium dose of Enpatoran.

Primary Outcome Measure

Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16 [ Time Frame: Baseline, week 16 ]

Locations (14)

FacilityCityStateZIPSite coordinators
The Lundquist Institute at Harbor-UCLA Medical CenterTorranceCalifornia90509-
Bay Area Arthritis and OsteoporosisBrandonFlorida33511-
Advance Medical Research CenterMiamiFlorida33135-
New Horizon Research Center, IncMiamiFlorida33165-
Charisma Medical and Research CenterMiami LakesFlorida33014-
HMD Research, LLCOrlandoFlorida32819-
D&H Tamarac Research Center, LLCTamaracFlorida33321-
RNA America Health SciencesSugar HillGeorgia30518-
Dawes Fretzin Dermatology Group, LLCIndianapolisIndiana46256-
AA MRC LLC Ahmed Arif Medical Research CenterGrand BlancMichigan48439-
University of MinnesotaMinneapolisMinnesota55455-
Across the Life SpanSmithfieldNorth Carolina27577-
Ohio State University - CTMO ParentColumbusOhio43215-
Ramesh C Gupta, MD - Memphis, TNMemphisTennessee38119-

Find similar trials in Torrance, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
The Lundquist Institute at Harbor-UCLA Medical Center· Torrance, CABay Area Arthritis and Osteoporosis· Brandon, FLAdvance Medical Research Center· Miami, FLNew Horizon Research Center, Inc· Miami, FLCharisma Medical and Research Center· Miami Lakes, FLHMD Research, LLC· Orlando, FL

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