NCT05120297已完成3 期
A Study to Evaluate the Efficacy and Safety of AK101 in Subjects With Moderate-to-severe Plaque Psoriasis
Akeso52 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2021年11月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 452
- 试验地点
- 52
- 主要终点
- Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to-severe plaque psoriasis.
详细描述
This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study. The purpose of this study is to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to- severe plaque psoriasis. Subjects will be randomized to receive AK101 or placebo injection subcutaneously, and follow up to week 16.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥ 18 years.
- •Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening.
- •At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥
- •Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
- •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
- •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 IL12/23 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
Experimental
干预措施: AK101 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline.
时间窗: At week 16
Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1).
时间窗: At week 16
次要结局
- PK: AK101 serum concentration at different time points after administration.(Baseline to week 16)
- Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA).(Baseline to week 16)
- Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE).(Baseline to week 16)
- Percentage of subjects who achieved at least 50% (PASI 50), 75% (PASI75, except week 16) and 90% (PASI 90) reduction in PASI score at each visit.(Baseline to week 16)
- Percentage change of PASI from baseline.(Baseline to week 16)
- Percentage of subjects who achieved sPGA 0/1 at each visit.(Baseline to week 16)
研究者
研究点 (52)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT06700499Akeso450
招募中
3 期
AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast CancerTriple-Negative Breast Cancer (TNBC)NCT06767527Akeso416
已完成
2 期
To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque PsoriasisPsoriasisSkin DiseasesNCT06061471Akeso454
已完成
1 期
A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, for Advanced Solid Tumors or With mXELOX/XELOX as First-line Therapy for Advanced Gastric or GEJ AdenocarcinomaGastric AdenocarcinomaAdvanced Solid TumorsGastroesophageal Junction AdenocarcinomaNCT03852251Akeso338
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK001AtopyNCT02563938Allakos Inc.34