boil-like lumps or abscesses that can occur in the armpits buttocks or under the breasts. groin Hidradenitis Suppurativa (acne inversa)
Conditions
Interventions
Test Product, Dose and Mode of Administration:
Sonelokimab will be presented as a prefilled syringe as sterile solution for
subcutaneous (SC) injection.
Depending on the randomized treatment arm, pa
at Weeks 10, 14, and 18 participants will receive placebo injections to
maintain the blind
* Arm 2: sonelokimab 240 mg at Weeks 0, 2, 4, 6, 8, followed by injections
every 4 weeks through Week 20
at Weeks 10, 14, and 18 participants will receive placebo injections to
maintain the blind.
Depending on the randomized treatment arm, participants in the placebo or
adalimumab arms will receive ei
* Sonelokimab 240 mg at Weeks 12, 14, 16, 18, and 20.
* Arm 4: adalimumab will be given as 160 mg at Week 0, followed by 80 mg once
every 2 weeks
at Weeks 2, 4, 6, 8, and 10.
o Adalimumab will be presented as a prefilled syringe as sterile solution for
SC injection.
o At the beginning of Part B at Week 12, participants in the adalimumab
refer
Sponsors
-
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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.
Exclusion criteria
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 evidence of tuberculosis infection (TB) at screening unless the following criteria apply: i. A full TB work-up within 12 weeks establishes no evidence of active 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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12, 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
| Measure | Time frame |
|---|---|
| 1. Proportion of participants achieving HiSCR50 at Week 12. 2. Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 12; 3. Proportion of participants achieving a Dermatology Life Quality Index (DLQI) total score of =3. | — |
Countries
Netherlands
Outcome results
None listed