The WILLOW study with enpatoran in SLE and CLE (SCLE and/or DLE)
- Conditions
- Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE)
- Registration Number
- 2024-510872-18-00
- Lead Sponsor
- Merck Healthcare KGaA
- Brief Summary
To evaluate the dose-response relationship of enpatoran in reducing disease activity based on CLASI-A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ended
- Sex
- Not specified
- Target Recruitment
- 127
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16 Cohort A: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) at Week 16
Cohort B: British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24 Cohort B: British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24
- Secondary Outcome Measures
Name Time Method Cohort B: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 24 Cohort B: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 24
Cohort B: Change from Baseline in Physician's Global Assessment at Week 24 Cohort B: Change from Baseline in Physician's Global Assessment at Week 24
Cohort A and Cohort B: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs of Special Interest, Clinically Significant Abnormalities in Laboratory Parameters and QT Interval Corrected Cohort A and Cohort B: Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), AEs of Special Interest, Clinically Significant Abnormalities in Laboratory Parameters and QT Interval Corrected
Cohort A and Cohort B: Change from Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Week 16 and Week 24 Cohort A and Cohort B: Change from Baseline in Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) at Week 16 and Week 24
Cohort A and Cohort B: Change from Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity at Week 16 and 24 Cohort A and Cohort B: Change from Baseline in Physician's Global Assessment of Cutaneous Lupus Disease Activity at Week 16 and 24
Cohort B: Participants with British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response and with Clinically Meaningful Corticosteroids (CS) Reduction Cohort B: Participants with British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response and with Clinically Meaningful Corticosteroids (CS) Reduction
Cohort A: Clinically Meaningful Corticosteroids (CS) Reduction Cohort A: Clinically Meaningful Corticosteroids (CS) Reduction
Cohort A: Ocurrence of Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Score 0 or 1 at Week 16 and Week 24 Cohort A: Ocurrence of Cutaneous Lupus Activity Investigator's Global Assessment (CLA-IGA) Score 0 or 1 at Week 16 and Week 24
Cohort B: Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24 Cohort B: Systemic lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 24
Cohort B: Lupus Low Disease Activity State (LLDAS) Attainment at Week 24 Cohort B: Lupus Low Disease Activity State (LLDAS) Attainment at Week 24
Cohort B: Remission Attainment at Week 24 Cohort B: Remission Attainment at Week 24
Cohort B: Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare Cohort B: Time to First Moderate/Severe British Isles Lupus Assessment Group (BILAG) Flare
Cohort B: Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare Cohort B: Time to First Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index (SFI) Severe Flare
Cohort A and B: Change from Baseline in Skindex 29+3 Symptom Domain Score at Week 24 Cohort A and B: Change from Baseline in Skindex 29+3 Symptom Domain Score at Week 24
Cohort A and B: Change from Baseline in the Skindex 29+3 Functioning and Emotion Domain Scores at Week 24 Cohort A and B: Change from Baseline in the Skindex 29+3 Functioning and Emotion Domain Scores at Week 24
Change from Baseline in the Skindex 29+3 Lupus-Specific Domain Score at Week 24 Change from Baseline in the Skindex 29+3 Lupus-Specific Domain Score at Week 24
Cohort A and B: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24 Cohort A and B: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scores at Week 24
Trial Locations
- Locations (29)
Hippokration Hospital
🇬🇷Thessaloniki, Greece
General Hospital Of Thessaloniki Papageorgiou
🇬🇷Efkarpia, Greece
Laiko General Hospital Of Athens
🇬🇷Athens, Greece
Prywatna Praktyka Lekarska Prof Dr Hab Med Pawel Hrycaj
🇵🇱Poznan, Poland
Twoja Przychodnia Opolskie Centrum Medyczne
🇵🇱Opole, Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
🇵🇱Szczecin, Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
🇵🇱Cracow, Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
🇵🇱Poznan, Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
🇵🇱Cracow, Poland
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
🇵🇱Bialystok, Poland
Scroll for more (19 remaining)Hippokration Hospital🇬🇷Thessaloniki, GreeceEfstratios VakirlisSite contact+302313308894svakirlis@hotmail.com