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Monoclonal Antibodies

Sonelokimab (M1095) for Hidradenitis Suppurativa

Phase 2
Waitlist Available
Research Sponsored by MoonLake Immunotherapeutics AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study Summary

This trial will show if a new medication is effective and safe for people with a skin condition called hidradenitis suppurativa.

Eligible Conditions
  • Hidradenitis Suppurativa

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hidradenitis Suppurativa Clinical Response 75
Secondary outcome measures
Change in International Hidradenitis Suppurativa Severity Score System
Dermatology Life Quality Index (DLQI)
Hidradenitis Suppurativa Clinical Response 50
+1 more

Side effects data

From 2013 Phase 4 trial • 50 Patients • NCT01644396
8%
LATENT TUBERCULOSIS
6%
RHINITIS
2%
ORAL HERPES
2%
RESPIRATORY TRACT INFECTION
2%
CONTUSION
2%
EXCORIATION
2%
ASPARTATE AMINOTRANSFERASE INCREASED
2%
BLOOD GLUCAGON INCREASED
2%
BLOOD TRIGLYCERIDES INCREASED
2%
RENAL COLIC
2%
EPISTAXIS
2%
URTICARIA
2%
ANAEMIA
2%
FURUNCLE
2%
HERPES SIMPLEX
2%
ALANINE AMINOTRANSFERASE INCREASED
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: sonelokimab dose 2Experimental Treatment1 Intervention
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Group II: sonelokimab dose 1Experimental Treatment1 Intervention
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Group III: adalimumabActive Control1 Intervention
Subjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B.
Group IV: PlaceboPlacebo Group1 Intervention
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be re-randomized to receive a sonelokimab dosage regimen during Part B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sonelokimab (M1095)
2022
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

MoonLake Immunotherapeutics AGLead Sponsor
3 Previous Clinical Trials
1,007 Total Patients Enrolled
2 Trials studying Hidradenitis Suppurativa
800 Patients Enrolled for Hidradenitis Suppurativa
Prof. Kristian Reich, M.D., Ph.D. (equ.)Study DirectorMoonLake Immunotherapeutics AG

Media Library

Sonelokimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05322473 — Phase 2
Hidradenitis Suppurativa Research Study Groups: Placebo, adalimumab, sonelokimab dose 2, sonelokimab dose 1
Hidradenitis Suppurativa Clinical Trial 2023: Sonelokimab Highlights & Side Effects. Trial Name: NCT05322473 — Phase 2
Sonelokimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05322473 — Phase 2
~76 spots leftby Jun 2025
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