Clinical trial NCT06411899: A 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: 422
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 & NR550) 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: Los Angeles
country: United States
facility: Clinical Site
state: California
city: Northridge
country: United States
facility: Clinical Site
state: California
city: Sacramento
country: United States
facility: Clinical Site
state: California
city: San Diego
country: United States
facility: Clinical Site
state: California
city: Coral Gables
country: United States
facility: Clinical Site
state: Florida
city: Coral Springs
country: United States
facility: Clinical Site
state: Florida
city: Hollywood
country: United States
facility: Clinical Site
state: Florida
city: Margate
country: United States
facility: Clinical Site
state: Florida
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Tampa
country: United States
facility: Clinical Site
state: Florida
city: Macon
country: United States
facility: Clinical Site
state: Georgia
city: Sandy Springs
country: United States
facility: Clinical Site
state: Georgia
city: West Dundee
country: United States
facility: Clinical Site
state: Illinois
city: Columbus
country: United States
facility: Clinical Site
state: Indiana
city: New Albany
country: United States
facility: Clinical Site
state: Indiana
city: Louisville
country: United States
facility: Clinical Site
state: Kentucky
city: Metairie
country: United States
facility: Clinical Site
state: Louisiana
city: Boston
country: United States
facility: Clinical Site
state: Massachusetts
city: Boston
country: United States
facility: Clinical Site
state: Massachusetts
city: Dearborn
country: United States
facility: Clinical Site
state: Michigan
city: Warren
country: United States
facility: Clinical Site
state: Michigan
city: Las Vegas
country: United States
facility: Clinical Site
state: Nevada
city: Bronx
country: United States
facility: Clinical Site
state: New York
city: New York
country: United States
facility: Clinical Site
state: New York
city: Boardman
country: United States
facility: Clinical Site
state: Ohio
city: Dayton
country: United States
facility: Clinical Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Clinical Site
state: Oklahoma
city: Charleston
country: United States
facility: Clinical Site
state: South Carolina
city: Nashville
country: United States
facility: Clinical Site
state: Tennessee
city: Frisco
country: United States
facility: Clinical Site
state: Texas
city: Houston
country: United States
facility: Clinical Site
state: Texas
city: Houston
country: United States
facility: Clinical Site
state: Texas
city: South Jordan
country: United States
facility: Clinical Site
state: Utah
city: Forest
country: United States
facility: Clinical Site
state: Virginia
city: Mill Creek
country: United States
facility: Clinical Site
state: Washington
city: Pleven
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: Edmonton
country: Canada
facility: Clinical Site
state: Alberta
city: Edmonton
country: Canada
facility: Clinical Site
state: Alberta
city: Sherwood Park
country: Canada
facility: Clinical Site
state: Alberta
city: Winnipeg
country: Canada
facility: Clinical Site
state: Manitoba
city: Fredericton
country: Canada
facility: Clinical Site
state: New Brunswick
city: Barrie
country: Canada
facility: Clinical Site
state: Ontario
city: London
country: Canada
facility: Clinical Site
state: Ontario
city: Markham
country: Canada
facility: Clinical Site
state: Ontario
city: Newmarket
country: Canada
facility: Clinical Site
state: Ontario
city: Toronto
country: Canada
facility: Clinical Site
state: Ontario
city: Toronto
country: Canada
facility: Clinical Site
state: Ontario
city: Montréal
country: Canada
facility: Clinical Site
state: Quebec
city: Quebec City
country: Canada
facility: Clinical Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Clinical Site
state: Quebec
city: Berlin
country: Germany
facility: Clinical Site
city: Bochum
country: Germany
facility: Clinical Site
city: Buxtehude
country: Germany
facility: Clinical Site
city: Erlangen
country: Germany
facility: Clinical Site
city: Essen
country: Germany
facility: Clinical Site
city: Frankfurt
country: Germany
facility: Clinical Site
city: Halle/ Saale
country: Germany
facility: Clinical SIte
city: Hannover
country: Germany
facility: Clinical Site
city: Langenau
country: Germany
facility: Clinical Site
city: Mahlow
country: Germany
facility: Clinical Site
city: Muenchen
country: Germany
facility: Clinical Site
city: Münster
country: Germany
facility: Clinical Site
city: Oldenburg
country: Germany
facility: Clinical Site
city: Wuppertal
country: Germany
facility: Clinical Site
city: Budapest
country: Hungary
facility: Clinical Site
city: Debrecen
country: Hungary
facility: Clinical Site
city: Debrecen
country: Hungary
facility: Clinical Site
city: Pécs
country: Hungary
facility: Clinical Site
city: Brescia
country: Italy
facility: Clinical Site
city: Catania
country: Italy
facility: Clinical Site
city: Chieti
country: Italy
facility: Clinical Site
city: Cona
country: Italy
facility: Clinical Site
city: Firenze
country: Italy
facility: Clinical Site
city: Milano
country: Italy
facility: Clinical Site
city: Modena
country: Italy
facility: Clinical Site
city: Napoli
country: Italy
facility: Clinical Site
city: Perugia
country: Italy
facility: Clinical Site
city: Pisa
country: Italy
facility: Clinical Site
city: Rome
country: Italy
facility: Clinical Site
city: Rozzano
country: Italy
facility: Clinical Site
city: Torino
country: Italy
facility: Clinical Site
city: Torrette
country: Italy
facility: Clinical Site
city: Oslo
country: Norway
facility: Clinical Site
city: Białystok
country: Poland
facility: Clinical Site
city: Gdańsk
country: Poland
facility: Clinical Site
city: Kraków
country: Poland
facility: Clinical Site
city: Kraków
country: Poland
facility: Clinical Site
city: Lublin
country: Poland
facility: Clinical Site
city: Ossy
country: Poland
facility: Clinical Site
city: Poznań
country: Poland
facility: Clinical Site
city: Sosnowiec
country: Poland
facility: Clinical Site
city: Szczecin
country: Poland
facility: Clinical Site
city: Warsaw
country: Poland
facility: Clinical Site
city: Warszawa
country: Poland
facility: Clinical Site
city: Warszawa
country: Poland
facility: Clinical Site
city: Wrocław
country: Poland
facility: Clinical Site
city: Łódź
country: Poland
facility: Clinical Site
city: Łódź
country: Poland
facility: Clinical Site
city: Lisboa
country: Portugal
facility: Clinical Site
city: Lisbon
country: Portugal
facility: Clinical Site
city: Porto
country: Portugal
facility: Clinical Site
city: Cardiff
country: United Kingdom
facility: Clinical Site
city: Dudley
country: United Kingdom
facility: Clinical Site
city: Leeds
country: United Kingdom
facility: Clinical Site
city: Salford
country: United Kingdom
facility: Clinical Site
Study officials:
affiliation: MoonLake Immunotherapeutics AG
name: Prof Kristian Reich, M.D., Ph.D. (equ.)
role: STUDY_DIRECTOR
References: