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A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (M1095-HS-302)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511363-28-00
Acronym
M1095-HS-302
Enrollment
292
Registered
2024-09-02
Start date
2024-09-24
Completion date
Unknown
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hidradenitis suppurativa (HS)

Brief summary

Percentage of participants achieving HiSCR75 at Week 16

Detailed description

Treatment-emergent adverse event (TEAEs), Serious adverse event (SAEs), TEAEs leading to study withdrawal, Adverse event of special interest (AESIs), Physical examinations, vital signs, and ECG results, Abnormal laboratory parameters (hematology, clinical chemistry, urinalysis), 1. Percentage of participants achieving HiSCR50 at Week 16, 2. Percentage of participants achieving IHS4-55 at Week 16, 5. Percentage of participants achieving a DLQI total reduction of ≥4 (minimal clinically important difference) at Week 16 among participants with a baseline DLQI ≥4, 3. Percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for skin pain in PGA among participants with a baseline NRS ≥3, 4. Absolute change in HiSQOL score at Week 16

Interventions

Sponsors

MoonLake Immunotherapeutics AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of participants achieving HiSCR75 at Week 16

Secondary

MeasureTime frame
Treatment-emergent adverse event (TEAEs), Serious adverse event (SAEs), TEAEs leading to study withdrawal, Adverse event of special interest (AESIs), Physical examinations, vital signs, and ECG results, Abnormal laboratory parameters (hematology, clinical chemistry, urinalysis), 1. Percentage of participants achieving HiSCR50 at Week 16, 2. Percentage of participants achieving IHS4-55 at Week 16, 5. Percentage of participants achieving a DLQI total reduction of ≥4 (minimal clinically important difference) at Week 16 among participants with a baseline DLQI ≥4, 3. Percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for skin pain in PGA among participants with a baseline NRS ≥3, 4. Absolute change in HiSQOL score at Week 16

Countries

Belgium, Bulgaria, Czechia, France, Germany, Ireland, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026