Clinical trial NCT06411379: Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Suppuration
Anti-Inflammatory Agents
Sonelokimab
Nanobody
Apocrine Gland Disease
Lead sponsor: MoonLake Immunotherapeutics AG
Sponsor class: INDUSTRY
First posted: 2024-05-13
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.


Eligibility criteria: Inclusion Criteria:

1. Participants must be at least 18 years of age at the time of signing the informed consent.
2. Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent.
3. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion.
4. Participants who have a total AN count of ≥5.
5. Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).

Exclusion Criteria:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
3. Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
4. Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
5. Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
6. Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.

Primary outcomes:
measure: Hidradenitis Suppurativa Clinical Response 75
timeFrame: Week 16
Secondary outcomes:
measure: Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
timeFrame: Week 16
measure: Change in International Hidradenitis Suppurativa Severity Score System
timeFrame: Week 16
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Week 16
measure: Reduction from Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
timeFrame: week 16
measure: Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16
timeFrame: Week 16
measure: Resolution of draining tunnels (DT100)
timeFrame: Week 16 and Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Site
state: Alabama
city: North Little Rock
country: United States
facility: Clinical Site
state: Arkansas
city: Fountain Valley
country: United States
facility: Clinical Site
state: California
city: Santa Monica
country: United States
facility: Clinical Site
state: California
city: Aventura
country: United States
facility: Clinical Site
state: Florida
city: Hialeah
country: United States
facility: Clinical Site
state: Florida
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Ocala
country: United States
facility: Clinical Site
state: Florida
city: Tampa
country: United States
facility: Clinical Site
state: Florida
city: Skokie
country: United States
facility: Clinical Site
state: Illinois
city: Plainfield
country: United States
facility: Clinical Site
state: Indiana
city: Murray
country: United States
facility: Clinical Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Clinical Site
state: Louisiana
city: Baltimore
country: United States
facility: Clinical Site
state: Maryland
city: Ann Arbor
country: United States
facility: Clinical Site
state: Michigan
city: Canton
country: United States
facility: Clinical Site
state: Michigan
city: Clarkston
country: United States
facility: Clinical Site
state: Michigan
city: Waterford
country: United States
facility: Clinical Site
state: Michigan
city: New Brighton
country: United States
facility: Clinical Site
state: Minnesota
city: Omaha
country: United States
facility: Clinical Site
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Site
state: Nevada
city: New York
country: United States
facility: Clinical Site
state: New York
city: Fargo
country: United States
facility: Clinical Site
state: North Dakota
city: Columbus
country: United States
facility: Clinical Site
state: Ohio
city: Murfreesboro
country: United States
facility: Clinical Site
state: Tennessee
city: Dallas
country: United States
facility: Clinical Site
state: Texas
city: Plano
country: United States
facility: Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Site
state: Texas
city: Morgantown
country: United States
facility: Clinical Site
state: West Virginia
city: Milwaukee
country: United States
facility: Clinical Site
state: Wisconsin
city: Gent
country: Belgium
facility: Clinical Site
city: Leuven
country: Belgium
facility: Clinical Site
city: Liège
country: Belgium
facility: Clinical Site
city: Woluwe-Saint-Lambert
country: Belgium
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Sofia
country: Bulgaria
facility: Clinical Site
city: Stara Zagora
country: Bulgaria
facility: Clinical Site
city: Calgary
country: Canada
facility: Clinical Site
state: Alberta
city: Edmonton
country: Canada
facility: Clinical Site
state: Alberta
city: Guelph
country: Canada
facility: Clinical Site
state: Ontario
city: Peterborough
country: Canada
facility: Clinical Site
state: Ontario
city: Richmond Hill
country: Canada
facility: Clinical Site
state: Ontario
city: Toronto
country: Canada
facility: Clinical Site
state: Ontario
city: Windsor
country: Canada
facility: Clinical Site
state: Ontario
city: Saskatoon
country: Canada
facility: Clinical Site
state: Saskatchewan
city: Ostrava
country: Czechia
facility: Clinical Site
city: Prague
country: Czechia
facility: Clinical Site
city: Praha 5
country: Czechia
facility: Clinical Site
city: Antony
country: France
facility: Clinical Site
city: Besançon
country: France
facility: Clinical Site
city: Brest
country: France
facility: Clinical SIte
city: Dijon
country: France
facility: Clinical Site
city: Le Mans
country: France
facility: Clinical Site
city: Lyon
country: France
facility: Clinical Site
city: Montpellier
country: France
facility: Clinical Site
city: Rouen
country: France
facility: Clinical Site
city: Saint-Mandé
country: France
facility: Clinical Site
city: Saint-Priest-en-Jarez
country: France
facility: Clinical Site
city: Toulouse
country: France
facility: Clinical Site
city: Augsburg
country: Germany
facility: Clinical Site
city: Bad Bentheim
country: Germany
facility: Clinical Site
city: Berlin
country: Germany
facility: Clinical Site
city: Bielefeld
country: Germany
facility: Clinical Site
city: Bochum
country: Germany
facility: Clinical Site
city: Bramsche
country: Germany
facility: Clinical Site
city: Darmstadt
country: Germany
facility: Clinical Site
city: Dresden
country: Germany
facility: Clinical Site
city: Gera
country: Germany
facility: Clinical Site
city: Hamburg
country: Germany
facility: Clinical Site
city: Kiel
country: Germany
facility: Clinical Site
city: Luebeck
country: Germany
facility: Clinical Site
city: Würzburg
country: Germany
facility: Clinical Site
city: Dublin
country: Ireland
facility: Clinical Site
city: Rotterdam
country: Netherlands
facility: Clinical Site
city: Chorzów
country: Poland
facility: Clinical Site
city: Katowice
country: Poland
facility: Clinical Site
city: Kielce
country: Poland
facility: Clinical Site
city: Olsztyn
country: Poland
facility: Clinical Site
city: Poznań
country: Poland
facility: Clinical Site
city: Szczecin
country: Poland
facility: Clinical Site
city: Warszawa
country: Poland
facility: Clinical Site
city: Wrocław
country: Poland
facility: Clinical Site
city: Trnava
country: Slovakia
facility: Clinical Site
city: Alcorcón
country: Spain
facility: Clinical Site
city: Alicante
country: Spain
facility: Clinical Site
city: Badalona
country: Spain
facility: Clinical Site
city: Barcelona
country: Spain
facility: Clinical Site
city: Barcelona
country: Spain
facility: Clinical Site
city: Barcelona
country: Spain
facility: Clinical Site
city: Cadiz
country: Spain
facility: Clinical Site
city: Córdoba
country: Spain
facility: Clinical Site
city: Granada
country: Spain
facility: Clinical Site
city: Granada
country: Spain
facility: Clinical Site
city: Granollers
country: Spain
facility: Clinical Site
city: Madrid
country: Spain
facility: Clinical Site
city: Madrid
country: Spain
facility: Clinical Site
city: Madrid
country: Spain
facility: Clinical Site
city: Madrid
country: Spain
facility: Clinical Site
city: Manises
country: Spain
facility: Clinical Site
city: Málaga
country: Spain
facility: Clinical Site
city: Santiago De Compostela
country: Spain
facility: Clinical Site
city: Sevilla
country: Spain
facility: Clinical Site
city: Valencia
country: Spain
facility: Clinical Site
city: Valencia
country: Spain
facility: Clinical Site
Study officials:
affiliation: MoonLake Immunotherapeutics AG
name: Prof Kristian Reich, M.D., Ph.D. (equ.)
role: STUDY_DIRECTOR
References: