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

Phase 2

Completed

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: Sonelokimab (M1095); Other: Placebo; Drug: Adalimumab

• Registration Number: NCT05322473
• Lead Sponsor: MoonLake Immunotherapeutics AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-11
• Study Start: 2022-04-25
• Primary Completion: 2023-05-09
• Study Completion: 2023-08-30
• Disposition First Posted: 2023-11-14
• Status Verified: 2024-05
• Disposition First Submitted: 2024-05-01
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sonelokimab dose 1	Sonelokimab (M1095)	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.
sonelokimab dose 2	Sonelokimab (M1095)	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.
Placebo	Placebo	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.
adalimumab	Adalimumab	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.

Primary Outcome Measures

Name	Time	Method
Hidradenitis Suppurativa Clinical Response 75	Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Hidradenitis Suppurativa Clinical Response 50	Week 12	Proportion of participants achieving HiSCR50
Change in International Hidradenitis Suppurativa Severity Score System	Week 12	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.
Dermatology Life Quality Index (DLQI)	Week 12	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.
Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)	Week 12	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).

Trial Locations

Locations (1)

Clinical Site; 🇵🇱 Łódź, Poland