NCT07455578招募中1 期
Phase 1b, Open-Label, Exploratory Biomarker Basket Study of S-4321 in Participants With an Autoimmune or Immune-Mediated Disease
Seismic Therapeutic AU Pty Ltd2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年6月1日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a multi-center, open-label Ph 1b basket study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker response, and preliminary efficacy of multiple doses of S-4321 in adults with autoimmune or immune-mediated disease including rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (PsO), cutaneous lupus erythematosus (CLE) with or without systemic manifestations, or atopic dermatitis (AD).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Participants Major Inclusion Criteria:
- •Adult males and females, 18 to 75 years of age (inclusive)
- •Body mass index (BMI) ≥18.0 and <40.0 kg/m2 with a minimum body weight of 45 kg
- •Use of adequate contraception for both males and females. Female volunteers must be of nonchildbearing potential or if of childbearing potential, must have a negative pregnancy test.
- •All Participants Major
排除标准
- •Have received a PD-1 agonist, immune checkpoint agonist, immune checkpoint inhibitor, anti-CD19 or anti-CD20 agents, cell therapy, B cell modulating agents, alkylating agents, or any other immune cell depleting therapy.
- •Have received azathioprine, cyclosporine, mycophenolate mofetil, or tacrolimus within 4 weeks
- •Unable or unwilling to discontinue a prohibited medication
- •Presence of clinically relevant immunosuppression
- •Current infection or history of severe infection
- •Any history of malignant disease, with some exceptions
- •Major inclusion/exclusion for each autoimmune or immune-mediated disease:
- •Confirmed diagnosis of moderate to severe active RA by the American College of Rheumatology (ACR) 2010/European League Against Rheumatism (EULAR) criteria for at least 3 months prior to the Screening 1 visit, and:
- •≥6 swollen joint count based on 66 joint count
- •≥6 tender joint count based on 68 joint count
- •Seropositive for RF and/or ACPA
- •Elevated hsCRP ≥1.2 times greater than the ULN
- •Does not have Class IV RA according to ACR revised criteria
- •Inadequate response to, or loss of response, or intolerance to:
- •>1 conventional synthetic DMARD after 3 months of therapy OR
- •>1 biologic DMARD/targeted synthetic DMARD after 3 months of therapy
- •Has not failed 3 or more bDMARDs and/or tsDMARDs
- •Confirmed diagnosis of adult-onset PsA classified by the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 3 months prior to the Screening 1 visit, with all of the following:
- •Active PsO defined by at least 1 psoriasis lesion
- •Active disease defined by >3 swollen joints and >3 tender joints using the 76/78 swollen and tender joint count
- •Received standard doses of NSAIDs for >4 weeks or csDMARDs for >3 months and has been on a stable dose for >8 weeks, or participant has intolerance to NSAIDs or DMARDs
- •Participants may be TNF inhibitor therapy naïve or may have received 1 prior TNF inhibitor
- •Has not had inadequate response or intolerance to 2 or more bDMARDs or csDMARDs
- •Confirmed diagnosis of moderate to severe plaque PsO for at least 6 months, with all of the following:
- •Psoriasis Area and Severity Index (PASI) >12 points
- •Static Physician's Global Assessment (sPGA) >3 points
- •Body surface area (BSA) of PsO involvement >10%
- •Cannot have a clinically significant flare within 12 weeks
- •Does not have history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis
- •Has not had inadequate response to more than 2 prior bDMARDs
- •For CLE (with or without systemic manifestations):
- •Histologically confirmed diagnosis of CLE with or without systemic manifestations for at least 6 months
- •Has active skin manifestations as measured by CLASI-A >10 or CLASI-A >8, if there is no alopecia or mucous membrane lesions
- •Participant must have an active CLE lesion despite an adequate trial of antimalarial treatment for at least 6 months.
- •Cannot have active lupus nephritis or moderate-to-severe or chronic kidney disease with eGFR <45 mL/min/1.73m2
- •Cannot have active neuropsychiatric SLE
- •Confirmed diagnosis of AD as defined by the American Academy of Dermatology: Guidelines of Care for the Management of Atopic Dermatitis for at least 12 months
- •Eczema Area and Severity Index (EASI) >16
- •Validated Investigator Global Assessment (vIGA-AD) >3
- •BSA of AD involvement >10%
- •PP-NRS) >4 (average of daily scores) during the 7 days prior to dosing
- •Inadequate response to existing topical medications within 6 months or has a history of intolerance to topical therapy as defined by at least 1 of the following:
- •Inability to achieve good disease control after use TCS for at least 4 weeks
- •Documented history of clinically significant AEs with the use of TCS
- •Failed systemic therapies intended to treat AD within 6 months
- •Additional inclusion/exclusion criteria will apply.
研究组 & 干预措施
S-4321
Experimental
SC Dose of S-4321
干预措施: S-4321 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Through Week 16
Incidence of serious adverse events (SAEs)
时间窗: Through Week 16
次要结局
- Change from baseline of soluble PD-1 (sPD-1)(Through Week 16)
- Incidence of anti-drug antibodies (ADAs)(Through Week 16)
- Serum concentration of S-4321(Through Week 16)
- Change from baseline in percent Receptor Occupancy (RO)(Through Week 16)
研究者
研究点 (2)
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