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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
Summary
This trial tests the effectiveness and safety of a new treatment for adults with moderate to severe hidradenitis suppurativa, a painful skin condition. The treatment aims to reduce symptoms.
Eligible Conditions
- Hidradenitis Suppurativa
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hidradenitis Suppurativa Clinical Response 75
Secondary study objectives
Change in International Hidradenitis Suppurativa Severity Score System
Dermatology Life Quality Index (DLQI)
Hidradenitis Suppurativa Clinical Response 50
+1 moreSide effects data
From 2013 Phase 4 trial • 50 Patients • NCT016443968%
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
5 Previous Clinical Trials
2,567 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to sonelokimab or any substances used to make it.You have previously tried antibiotics to treat your hidradenitis suppurativa, but they did not work or caused side effects.You have a minimum age of 18 years.You have another ongoing skin condition that might affect the evaluation of your hidradenitis suppurativa.You have already used more than 2 different types of biologic medications.You are allergic to adalimumab or any of its ingredients.You have been diagnosed with either ulcerative colitis or Crohn's disease.You have a total abscess and/or inflammatory nodule (AN) count of ≥5.You have been diagnosed with a skin condition called hidradenitis suppurativa, and have had symptoms for at least 6 months before the screening visit.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: adalimumab
- Group 3: sonelokimab dose 2
- Group 4: sonelokimab dose 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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