The trial is taking place at:
C

CAP Research | Quatre Bornes, Mauritius

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

Merck KGaA (EMD Serono) logo

Merck KGaA (EMD Serono)

Status and phase

Active, not recruiting
Phase 2

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Enpatoran low dose
Drug: Placebo
Drug: Enpatoran high dose
Drug: Enpatoran medium dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT05162586
2021-004648-27 (EudraCT Number)
MS200569_0003

Details and patient eligibility

About

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.

Enrollment

532 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Active CLE (SCLE and/or DLE) with a CLE disease area and activity index (CLASI-A) >= 8
  • Active SLE with presence of: CLASI-A >= 8 and BILAG 2004 1B, C, D (that is [i.e.], No BILAG 2004 A and No BILAG 2004 >= 2B) or BILAG 2004 >= 1A or 2B and 1 or 2 of the following: Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI >= 6 at Screening Visit and confirmed clinical hybrid SELENA-SLEDAI >= 4 (excluding laboratory parameters) at Day 1 Visit and/or CLASI-A >= 8
  • Receiving a stable dose of at least one of the following standards of care therapies for lupus: Immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids
  • Other protocol defined inclusion criteria could apply

Exclusion criteria

  • Autoimmune or rheumatic disease other than SLE or CLE
  • Dermatological diseases other than cutaneous manifestations of SLE or CLE
  • Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
  • Ongoing or active clinically significant viral, bacterial, or fungal infection
  • History of uncontrolled seizures or other neurological disorder
  • History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
  • History of malignancy
  • Other protocol defined exclusion criteria could apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

532 participants in 8 patient groups, including a placebo group

Cohort A: Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo
Cohort A: Enpatoran low dose
Experimental group
Description:
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.
Treatment:
Drug: Enpatoran low dose
Cohort A: Enpatoran medium dose
Experimental group
Description:
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.
Treatment:
Drug: Enpatoran medium dose
Cohort A: Enpatoran high dose
Experimental group
Description:
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.
Treatment:
Drug: Enpatoran high dose
Cohort B (Part 1 + Part 2): Placebo
Placebo Comparator group
Description:
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 .
Treatment:
Drug: Placebo
Cohort B (Part 1 + Part 2): Enpatoran high dose
Experimental group
Description:
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.
Treatment:
Drug: Enpatoran high dose
Cohort B (Part 2): Enpatoran low dose
Experimental group
Description:
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.
Treatment:
Drug: Enpatoran low dose
Cohort B (Part 2): Enpatoran medium dose
Experimental group
Description:
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.
Treatment:
Drug: Enpatoran medium dose

Trial contacts and locations

165

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Central trial contact

US Medical Information; Communication Center

Data sourced from clinicaltrials.gov

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