Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: Sonelokimab (M1095)
* Drug: Adalimumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is ≥18 years of age; 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; Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5; 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); 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; 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: Participants with known hypersensitivity to sonelokimab or any of its excipients; Participants with known hypersensitivity to adalimumab or any of its excipients; Participant has a draining fistula count of ≥20 at the Screening Visit; Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa; Prior exposure to more than 2 biologic response modifiers; Participant has a diagnosis of ulcerative colitis or Crohn's disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sonelokimab dose 1<br>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. | Drug: Sonelokimab (M1095)<br>* randomized treatment; parallel-group<br>|
| Experimental: sonelokimab dose 2<br>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. | Drug: Sonelokimab (M1095)<br>* randomized treatment; parallel-group<br>|
| Placebo Comparator: Placebo<br>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. | Other: Placebo<br>* randomized treatment; parallel-group<br>|
| Active Comparator: adalimumab<br>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. | Drug: Adalimumab<br>* randomized treatment; parallel-group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hidradenitis Suppurativa Clinical Response 75 | Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hidradenitis Suppurativa Clinical Response 50 | Proportion of participants achieving HiSCR50 | Week 12 | 
| Change in International Hidradenitis Suppurativa Severity Score System | Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) The IHS4 score is calculated as follows: number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate and 11 or higher signifies severe disease. | Week 12 | 
| Dermatology Life Quality Index (DLQI) | Proportion of participants achieving a Dermatology Life Quality Index (DLQI) total score of ≤5 The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health-related quality of life impairment. | Week 12 | 
| Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) | Proportion of participants achieving at least 30% reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3 The NRS is a numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Inversa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Adalimumab, Anti-Inflammatory Agents, Sonelokimab, Nanobody, Folliculitis, Hidradenitis Suppurativa, Apocrine Gland Disease