NCT05509361已完成3 期
An Open-label, Single-arm, Multi-center Study to Evaluate the Long-term Safety and Efficacy of AK101 Injection in Subjects With Moderate-to-severe Plaque Psoriasis
Akeso1 个研究点 分布在 1 个国家目标入组 950 人开始时间: 2022年4月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 950
- 试验地点
- 1
- 主要终点
- Occurrence of Treatment-Emergent Adverse Event
研究概览
简要总结
This is an open-label Phase III clinical study to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis.
详细描述
This is an open-label, single-arm, multi-center phase III study. The purpose of this study is to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis. Subjects who have completed the previous Akeso registration trial with AK101 injection (AK101-302) and subjects who are to be newly enrolled will both receive AK101 135mg injection subcutaneously.
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
- •Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:
- •Subjects can continue to participate in this study based on assessment of investigator.
- •Subjects voluntarily participate in this study.
- •Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the treatment period and for at least 6 months after the last study drug administration.
- •Applicable for subjects newly enrolled:
- •Male or female subjects aged ≥ 18 years old.
- •Subjects diagnosed with moderate-to-severe plaque psoriasis and are applicable to systematic treatment.
- •At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥
- •Subjects who are applicable for biological agents, based on the assessment of investigator.
- •Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 6 months after the last study drug administration.
排除标准
- •Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:
- •Subjects who have severe AE or SAE occurred in an Akeso trial with AK101 injection.
- •Subjects who used prohibited drugs in an Akeso trial with AK101 injection.
- •Subjects performed poor compliance in an Akeso trial with AK101 injection, based on the assessment of investigator.
- •Subjects with any other disease, abnormal physical examination or abnormal laboratory examination leading to inapplicable for participating this study, based on the assessment of investigator.
- •Applicable for subjects newly enrolled:
- •Forms of psoriasis other than chronic plaque-type psoriasis.
- •History or evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
- •Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
- •History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
- •History of prohibited psoriasis treatments within 2/4 weeks before randomization.
- •History of IL-12/23 or IL-23 inhibitors therapy.
- •Inadequate washout period of prior biological therapy.
- •History of malignant tumour within 5 years before screening.
- •Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator would place the subject at risk, interfere with participation or interpretation of the study.
研究组 & 干预措施
AK101 135mg
Experimental
Subjects who have completed AK101-302 receive AK101 135mg injection subcutaneously every 12 weeks.
Subjects newly enrolled receive AK101 135mg injection subcutaneously at Week 0, 4 and then every 12 weeks.
干预措施: AK101 injection SC (Biological)
结局指标
主要结局
Occurrence of Treatment-Emergent Adverse Event
时间窗: up to 52 weeks
To evaluate long-term safety as assessed by occurrence of TEAE.
次要结局
- Pharmacokinetics Assessment of AK101 Serum Concentration(up to 52 weeks)
- Immunogenicity Assessment with Number and Percentage of Subjects with Detectable Anti-AK101 Antibody (ADA)(up to 52 weeks)
- Occurrence of Serious Adverse Event and Adverse Events of Special Interest(up to 52 weeks)
- Percentage of Subjects Who Achieved at least 50% (PASI 50), 75% (PASI 75) and 90% (PASI 90) Reduction in Psoriasis Area and Severity Index (PASI) Score(up to 52 weeks)
- Percentage of Subjects Who Achieved Static Physician Global Assessment (sPGA) Clear(0) or Almost Clear(1)(up to 52 weeks)
研究者
研究点 (1)
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