A Phase I/II, Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS).
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of HB0043 in Patients with Moderate to Severe HS
研究概览
简要总结
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.
详细描述
The total duration of the study is 28 weeks and consists of: Screening (up to 4 weeks), Treatment Period (20 weeks) and Safety Follow-Up (treatment-free follow-up for 4 weeks).
Participants who prematurely discontinue study treatment are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •1. Understand the research procedure of this study and provide written informed consent;
- •Male or female, age 18 years or greater;
- •Diagnosis of HS with a disease duration of at least 6 months before screening;
- •Moderate to severe HS, concurrently meeting the following three criteria:
- •HS lesions in at least 2 distinct anatomic area;
- •One of the HS lesions must be Hurley Stage II or Hurley Stage III;
- •Total abscess and inflammatory nodule (AN) count of greater than or equal to 3;
- •Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up.
排除标准
- •1. Participants with known hypersensitivity to HB0043 or any of its excipients;
- •Participant has a draining fistula count of ≥20 at the Screening Visit;
- •Presence of other active autoimmune diseases except HS, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis;
- •Participant has any other active skin disease or condition that may interfere with the assessment of hidradenitis suppurativa;
- •History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ);
- •History of recurrent or recent serious infection;
- •Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection;
- •Pregnant or lactating women;
- •Any reason why, in the opinion of the investigator, the patient should not participate.
研究组 & 干预措施
HB0043: Low dose
Participants assigned to arm 1 will receive a low dose of HB0043 via intravenous infusion every two weeks starting from week 0. The dose of HB0043 will adjusted to high dose at weeks 10, and the frequency remains Q2W. The frequency will adjusted to Q4W from weeks16, the last administration is weeks 20.
干预措施: HB0043 (Drug)
HB0043: Medium dose
Participants assigned to Arm 2 will receive a medium dose of HB0043 via intravenous infusion every two weeks, commencing at week 0, and then at weeks 16 and 20.
干预措施: HB0043 (Drug)
HB0043: High dose
Participants assigned to Arm 3 will receive a high dose of HB0043 via intravenous infusion every two weeks, commencing at week 0, and then at weeks 16 and 20.
干预措施: HB0043 (Drug)
结局指标
主要结局
Safety and Tolerability of HB0043 in Patients with Moderate to Severe HS
时间窗: From randomization to end of study, assessed up to 24 weeks.
The incidence rate, characteristics, relevance, and severity of treatment-emergent adverse events (TEAEs) experienced by subjects during the treatment period.
次要结局
- Percentage of participants achieving HiSCR(Week 16 and 24)
- Change From Baseline in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count(Week 16 and 24)
- Change From Baseline in the number of lesions(Week 16 and 24)
- Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA-NRS(Week 16 and 24)
- Percentage of participants achieving HiSCR75(Week 16 and 24)
- Percentage of participants achieving HiSCR90(Week 16 and 24)
- Percentage of participants achieving HiSCR100(Week 16 and 24)
- Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)(Week 16 and 24)
- Serum HB0043 concentrations throughout the study(From randomization to end of study, assessed up to 24 weeks.)
- Incidence of anti-HB0043 antibody positive response throughout the study(From randomization to end of study, assessed up to 24 weeks.)
- Change of the most severe Patient's Global Assessment of Skin Pain (PGA Skin Pain) within the past 24 hours(Week 16 and 24)
- Dermatology Life Quality Index (DLQI)(Week 16 and 24)
- hange of Hidradenitis Suppurativa Area and Severity Index Revised (HASI-R)(Week 16 and 24)
- Change of HIDRA score(Week 16 and 24)
- Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)(Week 16 and 24)
- Change of Numerical Rating Scale (NRS)(Week 16 and 24)
- Pharmacodynamic indicators include but are not limited to IL-17 and IL-36.(From randomization to end of study, assessed up to 24 weeks.)