A Randomized, Double-blinded, Placebo-controlled, Phase IIb Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 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 multiple-center, randomized, double-blind, placebo-controlled Phase IIb study to evaluate the efficacy and safety of AK101, an anti-IL-12/23 p40 antibody, when administered subcutaneously, in subjects with moderate-to-severe plaque psoriasis. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blinded treatment and long-term follow-up period(up to 52 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have had Plaque Psoriasis diagnosed at least 6 months prior to screening.
- •Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area. Psoriasis area and severity index(PASI) ≥
- •Physicians Global Assessment score ≥
- •Candidate for systemic therapy, defined as having psoriasis inadequately controlled by topical treatment (including topical corticosteroids) and/or phototherapy and/or previous systemic therapy.
- •Women of childbearing potential should not be in pregnancy or lactation, men and women of childbearing potential must agree to use adequate birth control measures during study participation and for 6 months after the last doses of study treatment.
- •Ability to provide written informed consent and to be compliant with the schedule of protocol assessments.
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.
排除标准
- •Had nonplaque forms of psoriasis (e.g., Guttate, erythrodermic, or pustular).
- •Had other active skin diseases or skin infections (e.g., Bacterial, fungal or viral infection) that could affect psoriasis evaluation.
- •Had imaging diagnosis of pulmonary infection or fibrosis during the 3 months prior to screening.
- •History or evidence of active or latent tuberculosis at screening.
- •Serious systemic infections or local infections during the 2 months prior to screening.
- •History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
- •Known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
- •Known history of alcohol or drug abuse.
- •History or known presence of recurrent or chronic infection (e.g., hepatitis or C, human immunodeficiency virus [HIV], syphilis, TB).
- •Had received any DMARDs (e.g., Anti-malaria drug, retinoids, interferon, lithium) during 2 weeks prior to screening.
- •Had received any physical therapy (e.g., PUVA, ultra-violet therapy, tanning beds) during 2 weeks prior to screening.
- •Had received any systemic psoriasis therapy (e.g., Glucocorticoid, retinoids, ciclosporin, methotrexate, or tripterygium) during 4 weeks prior to screening.
- •Had enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials.
- •Had received previous treatment with any anti-IL-12/IL-23, IL-12, IL-23, IL-17 therapy for the treatment of psoriasis or psoriatic arthritis.
- •Had received natalizumab or any other drugs that regulate B cells or T cells (rituximab, abatacept, alemtuzumab) during 12 months prior to screening.
- •Had received other biologic therapy (e.g., TNF inhibitor) during 6 months prior to screening.
研究组 & 干预措施
AK101 90mg - every 8 weeks
AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 8 weeks
干预措施: AK101 (Biological)
AK101 90mg -every 12 weeks
AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 12 weeks
干预措施: AK101 (Biological)
AK101 45mg every 8 weeks
AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 8 weeks
干预措施: AK101 (Biological)
AK101 45mg - every 12 weeks
AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 12 weeks
干预措施: AK101 (Biological)
AK101 135mg -every 8 weeks
AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 8 weeks
干预措施: AK101 (Biological)
AK101 135mg -every 12 weeks
AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 12 weeks
干预措施: AK101 (Biological)
Placebo to AK101
Placebo on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously at Week 12, 16 and then every 12 weeks
干预措施: AK101 (Biological)
Placebo to AK101
Placebo on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously at Week 12, 16 and then every 12 weeks
干预措施: Placebo (Biological)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAEs)
时间窗: From the time of signing the informed consent form till last follow-up visit (Up to Week 52)
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) at Week 12
时间窗: Week 12
次要结局
- Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90) at Week 12(At baseline and Week 12)
- Number of participants who achieved 100% reduction in Psoriasis Area and Severity Index (PASI100) at Week 12(Up to Week 52)
- Minimum observed concentration (Cmin) of AK101 at steady state(Up to Week 52)
- Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75)(Up to Week 52 (except for Week 12))
- Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline(Up to Week 52)
- Proportion of subjects who achieve Physician Global Assessment (PGA) of clear or almost clear (0 or 1) after treatment(Up to Week 52)
- Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90)(Up to Week 52( except for Week 12))
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(Up to Week 52)