NCT07828860尚未招募1 期
A Phase 1b, Open-label Study Evaluating the Safety and Efficacy of Oral Soquelitinib in Adults With Moderate-to-Severe Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- Incidence of adverse events, changes in laboratory values, vital signs, and ECGs
研究概览
简要总结
Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa
详细描述
A Phase 1b, Open-label Study Evaluating the Safety and Efficacy of Oral Soquelitinib in Adults with Moderate-to-Severe Hidradenitis Suppurativa
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female, ≥18 years of age at the time of signing the informed consent form (ICF)
- •A diagnosis of moderate-to-severe HS for at least 1 year prior to the Screening visit from review of medical history and/or participant interview.
- •A total AN count of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) including at least 2 palpable inflammatory nodules at both the Screening and Baseline (Day 1) visits.
- •Draining tunnel count of ≤20 at the Screening or Baseline (Day 1) visit.
- •HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline (Day 1) visits.
- •History of inadequate response, intolerance, or contraindication to a course of systemic antibiotics for treatment of HS or exhibited recurrence after discontinuation of antibiotics through study participant interview and/or review of medical history.
- •Willing and able to undergo the required skin biopsies.
排除标准
- •Currently experiencing, or previous history of, other concomitant skin conditions (eg, psoriasis, cutaneous lupus, previous burns, or extensive tattoos) that would interfere with evaluations of the effect of study intervention on HS.
- •Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit (Day 1) or that could interfere with the appropriate assessment of HS lesions.
- •Known immunodeficiency syndrome, history of an invasive infection (eg, sepsis, severe pneumonia, osteomyelitis), or active non-skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline (Day 1).
- •History of immunosuppression not related to medication (such as common variable hypogammaglobulinemia), history of clinically significant medical conditions (such as anemia, neutropenia, thrombocytopenia, abnormal renal function, or abnormal liver function), planned surgical procedures, or any other reason which in the opinion of the investigator or sponsor would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study intervention, or would put the participant at risk by participating in the study; or permanently wheelchair-bound or bedridden or very poor functional status which prevents the ability to perform self-care.
- •Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular (eg, unstable angina, unstable arterial hypertension, moderate to severe heart failure [New York Heart Association Class III/IV]), respiratory, gastrointestinal, endocrine, hematologic, or neurologic disorders that would potentially affect participant safety within the study or confound efficacy and safety assessments.
研究组 & 干预措施
Single-Arm
Other
Participants receive open-label single arm of active tablets orally twice daily for 84 days.
干预措施: Soquelitinib (Drug)
结局指标
主要结局
Incidence of adverse events, changes in laboratory values, vital signs, and ECGs
时间窗: up to 30 days after last intervention administration
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib, including changes in laboratory values, vital signs, and ECGs
次要结局
- 1) percentage of participants achieving HiSCR50 2) percentage of participants achieving HiSCR75 3) percentage of participants achieving HiSCR90(Week 12)
- Efficacy as measured by Hidradenitis Suppurativa Severity Score System (IHS4)(Week 12)
- Efficacy as measured by change and percentage change in lesion count(Week 12)
- 1) at least 30% reduction and at least 1-pt reduction and 2) at least 3-pt reduction from Baseline in the weekly average of daily HS-Skin Pain NRS(Week 12)
- Evaluate change from baseline in Hidradenitis Suupurativa Quality of Life (HiSQoL) Score(Week 12)
- Evaluate change from baseline in Dermatology Life Quality Index (DLQI)(Week 12)
研究者
研究点 (11)
Loading locations...
相似试验
招募中
3 期
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS2)Hidradenitis Suppurativa2022-501753-36-00Incyte Corp.291
招募中
不适用
Hidradeinitis suppurativa treated with twice daily dose of oral tofacitinibCTRI/2025/07/09104621
进行中（未招募）
2 期
A 24-Week Real-World Study of Upadacitinib in Moderate-to-Severe Hidradenitis SuppurativaHidradenitis Suppurativa (Acne Inversa)NCT07727889Peking Union Medical College50
尚未招募
2 期
A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)Hidradenitis Suppurativa (HS)NCT07766005Spyre Therapeutics, Inc.150
招募中
2 期
Study to Evaluate Soquelitinib in Participants With Moderate to Severe ADAtopic DermatitisNCT07441395Corvus Pharmaceuticals, Inc.200