Evaluating the safety and pharmacokinetics of sonelokimab in adolescents with hidradenitis suppurativa
An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents Aged ≥12 to ≤17 Years at the Time of Study Inclusion With Active Moderate to Severe Hidradenitis Suppurativa
This study is testing a new treatment called sonelokimab to see if it is safe and effective for teenagers aged 12 to 17 with moderate to severe hidradenitis suppurativa who haven't had enough help from antibiotics.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | MoonLake Immunotherapeutics AG Industry-sponsored |
| Drugs / interventions | sonelokimab |
| Locations | 10 sites (Macon, Georgia and 9 other locations) |
| Trial ID | NCT06768671 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the pharmacokinetics and safety of sonelokimab, a treatment for moderate to severe hidradenitis suppurativa (HS), in adolescents aged 12 to 17. Participants will receive the medication and be monitored for its effects and any potential side effects. The study focuses on adolescents who have had HS for at least six months and have not responded adequately to systemic antibiotics. The goal is to gather data that could inform future treatment options for this challenging skin condition.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 17 with a diagnosis of moderate to severe hidradenitis suppurativa and a history of inadequate response to systemic antibiotics.
Not a fit: Patients with known hypersensitivity to sonelokimab or those with other active skin diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for adolescents suffering from moderate to severe hidradenitis suppurativa.
How similar studies have performed: While this specific approach is novel, similar studies evaluating treatments for hidradenitis suppurativa have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent. 2. Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent. 3. Participants who have moderate to severe HS as determined by the refined Hurley staging (Stages IB and IC, IIB and IIC, and III). 4. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS . 5. Participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study. 6. Participants with a body weight of ≥ 40 kg. Exclusion Criteria: 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants with a draining fistula count of ≥20 at the Screening Visit. 3. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS. 4. Participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk. 5. Participants who have history or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk. 6. Participants with any other skin disease or other medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS. 7. Participants with a confirmed or suspected diagnosis of inflammatory bowel disease.
Where this trial is running
Macon, Georgia and 9 other locations
- Clinical Site — Macon, Georgia, United States (Recruiting)
- Clinical Site — Sandy Springs, Georgia, United States (Recruiting)
- Clinical Site — Columbus, Indiana, United States (Recruiting)
- Clinical Site — Murray, Kentucky, United States (Recruiting)
- Clinical Site — Waterford, Michigan, United States (Recruiting)
- Clinical Site — Fargo, North Dakota, United States (Recruiting)
- Clinical Site — Dallas, Texas, United States (Recruiting)
- Clinical Site — Plano, Texas, United States (Recruiting)
- Clinical Site — San Antonio, Texas, United States (Recruiting)
- Clinical Site — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Moonlake Clinical Trial Helpdesk
- Email: ClinicalTrials@moonlaketx.com
- Phone: +41 41 510 8022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.