Clinical trial NCT05322473: Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
Official title: Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Suppuration
Adalimumab
Anti-Inflammatory Agents
Sonelokimab
Nanobody
Folliculitis
Apocrine Gland Disease
Acne Inversa
Lead sponsor: MoonLake Immunotherapeutics AG
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 234
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 demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.


Eligibility criteria: Inclusion Criteria:

1. Participant is ≥18 years of age;
2. Participant has been diagnosed with hidradenitis suppurativa as determined by the investigator and has a history of signs and symptoms of hidradenitis suppurativa dating back at least 6 months prior to the Screening Visit;
3. Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5;
4. Participant has hidradenitis suppurativa lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (i.e., be Hurley Stage II or III);
5. Participant 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;
6. Participant must be, in the opinion of the investigator, at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information.

Exclusion Criteria:

1. Participants with known hypersensitivity to sonelokimab or any of its excipients;
2. Participants with known hypersensitivity to adalimumab or any of its excipients;
3. Participant has a draining fistula count of ≥20 at the Screening Visit;
4. Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa;
5. Prior exposure to more than 2 biologic response modifiers;
6. Participant has a diagnosis of ulcerative colitis or Crohn's disease.

Primary outcomes:
measure: Hidradenitis Suppurativa Clinical Response 75
timeFrame: Week 12
Secondary outcomes:
measure: Hidradenitis Suppurativa Clinical Response 50
timeFrame: Week 12
measure: Change in International Hidradenitis Suppurativa Severity Score System
timeFrame: Week 12
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Week 12
measure: Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
timeFrame: Week 12
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Clinical Site
state: California
city: Los Angeles
country: United States
facility: Clinical Site
state: California
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Ormond Beach
country: United States
facility: Clinical Site
state: Florida
city: Saint Petersburg
country: United States
facility: Clinical Site
state: Florida
city: Tampa
country: United States
facility: Clinical Site
state: Florida
city: Indianapolis
country: United States
facility: Clinical Site
state: Indiana
city: Beverly
country: United States
facility: Clinical Site
state: Massachusetts
city: Boston
country: United States
facility: Clinical Site
state: Massachusetts
city: Omaha
country: United States
facility: Clinical Site
state: Nebraska
city: New York
country: United States
facility: Clinical Site
state: New York
city: Philadelphia
country: United States
facility: Clinical Site
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Site
state: South Carolina
city: Nashville
country: United States
facility: Clinical Site
state: Tennessee
city: Bellaire
country: United States
facility: Clinical Site
state: Texas
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: Winnipeg
country: Canada
facility: Clinical Site
state: Manitoba
city: Fredericton
country: Canada
facility: Clinical Site
state: New Brunswick
city: Saint John's
country: Canada
facility: Clinical Site
state: Newfoundland and Labrador
city: Hamilton
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: Peterborough
country: Canada
facility: Clinical Site
state: Ontario
city: Saskatoon
country: Canada
facility: Clinical Site
state: Saskatchewan
city: Bad Bentheim
country: Germany
facility: Clinical Site
city: Berlin
country: Germany
facility: Clinical Site
city: Berlin
country: Germany
facility: Clinical Site
city: Berlin
country: Germany
facility: Clinical Site
city: Bochum
country: Germany
facility: Clinical Site
city: Darmstadt
country: Germany
facility: Clinical Site
city: Dresden
country: Germany
facility: Clinical Site
city: Frankfurt
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: Mahlow
country: Germany
facility: Clinical Site
city: München
country: Germany
facility: Clinical Site
city: Münster
country: Germany
facility: Clinical Site
city: Dublin
country: Ireland
facility: Clinical Site
city: Bergen Op Zoom
country: Netherlands
facility: Clinical Site
city: Rotterdam
country: Netherlands
facility: Clinical Site
city: Gdańsk
country: Poland
facility: Clinical Site
city: Kraków
country: Poland
facility: Clinical Site
city: Olsztyn
country: Poland
facility: Clinical Site
city: Ossy
country: Poland
facility: Clinical Site
city: Ostrowiec Świętokrzyski
country: Poland
facility: Clinical Site
city: Poznań
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: Wrocław
country: Poland
facility: Clinical Site
city: Łódź
country: Poland
facility: Clinical Site
Study officials:
affiliation: MoonLake Immunotherapeutics AG
name: Prof. Kristian Reich, M.D., Ph.D. (equ.)
role: STUDY_DIRECTOR
References: