Evaluation of Sonelokimab for the treatment of patients with active moderate to severe HS

Phase 1

• Conditions: Active moderate to severe hidradenitis suppurativa; MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-005928-38-IE
• Lead Sponsor: MoonLake Immunotherapeutics AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-06
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. =18 years of age.
2. Diagnosed with HS and has a history of signs and symptoms of HS dating back at least 6 months.
3. Total AN count (i.e., abscesses and/or inflammatory nodules) of =5.
4. Subject has HS 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. Subject had an inadequate response to appropriate systemic antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS).
6. Participants must a suitable candidate for treatment with adalimumab per approved local product information. If a chest X-ray or computed tomography (CT) for tuberculosis (TB) screening is required per local guidance, the X-ray or CT must have been taken within 3 months prior to the Screening.
7. If the subject is female, must be of non-childbearing potential or if of childbearing potential, participant must agree to use highly effective methods of contraception.
8. Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0/Day1 prior to the first administration of study treatment.
9. If male, participant must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for 12 weeks after the last dose of study drug, unless surgically sterile.
10. Participant is considered reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the investigator.
11. Participant is able to understand and provide signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 189
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

1. Known hypersensitivity to sonelokimab, adalimumab or any of its excipients.
2. Draining fistula count of =20.
3. Any other active skin disease or condition that may interfere with the assessment of HS.
4. Subject who currently use or plan used one or more prohibited treatments specified in this protocol.
5. Subjects enrolling in the non-antibiotic strata: use of systemic antibiotics for the treatment of HS within 28 days.
6. Previous exposure or subject in a study of brodalumab (anti-IL-17RA) and/or bimekizumab (anti-IL17 A/F).
7. Unsuitable for interleukin (IL)-17A therapy and anti-tumor necrosis factor alpha (TNFa) therapy.
8. Prior exposure to more than 2 biologic response modifiers.
9. Diagnosis of ulcerative colitis or Crohn’s disease.
10. Subject has an active infection or history of infections.
11. Participant with:
a. History of active TB.
b. Evidence of TB infection, unless the following criteria apply:
i. A full TB work-up within 12 weeks establishes no evidence of active or latent TB infection.
ii. Positive for latent TB per work-up must have completed sufficient treatment at least 4 weeks prior.
12. Any current nontuberculous mycobacterial (NTM) infection or any history of pulmonary NTM infection.
13. Concurrent acute or chronic viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
14. Evidence of human immunodeficiency virus (HIV) infection.
15. Tests positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.
16. Concurrent malignancy or a history of malignancy during the past 5 years of with the following exceptions:
a. =3 successfully excised or ablated, basal cell carcinomas of the skin.
b. One squamous cell carcinoma of the skin not worse than Stage T1 that has been successfully treated, with no signs of recurrence or metastases for at least the past 2 years.
c. Actinic keratosis.
d. Squamous cell carcinoma in situ of the skin successfully treated >6 months.
e. Localized carcinoma in situ of the cervix treated and considered cured.
17. History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
18. Primary immunodeficiencies, prior splenectomy, or suppressive conditions, including subjects taking immunosuppressive therapy following organ transplants.
19. Had major surgery (e.g., hip replacement, aneurysm removal) within 6 months or is planning to have major surgery during the study.
20. History or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that would compromise the safety or interfere with the subject’s participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk.
21. Has received live (including attenuated) vaccination within 8 weeks or planned during the study and up to at least 12 weeks after the last dose of study drug.
22. Has received Bacillus Calmette-Guérin vaccination within 1 year.
23. Presence of active suicidal ideation, or positive suicidal behavior; any history of suicidal attempt (including an actual attempt, interrupted attempt, or aborted attempt), or suicidal ideation in the past 6 months.
24. Presence of moderately severe depression or severe depression. Subjects are permitted to use 1 medication to treat depression provided dose is stable for 4 weeks prior. Subjects on multiple m

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified