Phase 2, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in patients with active moderate to severe hidradenitis suppurativa - MoonLake M1095-HS-201 (6012/0002)

-0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: -
入组人数: 8

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•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
•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.

排除标准

•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
•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.
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