A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of GR2002 Injection in Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Phase Ib clinical trial evaluating the safety tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR2002 Injection in patients with moderate to severe atopic dermatitis. The dosing period was 12 weeks and followed up to 20 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Patients need to meet Williams diagnostic criteria, have had AD for at least 1 year, and:EASI ≥16, IGA score ≥3, and AD involvement of ≥10% of BSA;
- •Inadequate response or intolerance to prior topical glucocorticoid (TCS) therapy for the treatment of AD;
- •Voluntary informed consent.
排除标准
- •Current malignancy or history of malignancy;
- •History of vital organ transplantation or hematopoietic stem cell/bone marrow transplantation;
- •Subjects may have active Mycobacterium tuberculosis infection;
- •Systemic anti-infective therapy required for chronic or acute active infection within 4 weeks prior to the baseline visit;
- •History of known or suspected immunosuppression;
- •Presence of skin comorbidities that may interfere with evaluation;
- •Suspected or confirmed allergy to the test drug (including excipients, similar drugs);
- •History of alcohol or drug abuse within 3 months prior to screening；
- •Pregnant or lactating women who need to breastfeed；
- •Major surgery planned during the trial；
- •The elution cycle of the drug of interest is not met at the baseline；
- •Subjects of childbearing potential and partners refusing to use highly effective contraception.
研究组 & 干预措施
GR2002 injection 2
GR2002 injection dose 2/Placebo，multiple-dose，Subcutaneous，high frequency
干预措施: GR2002 injection (Biological)
GR2002 injection 3
GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，high frequency
干预措施: GR2002 injection (Biological)
GR2002 injection 1
GR2002 injection dose 1/Placebo，multiple-dose，Subcutaneous，high frequency
干预措施: GR2002 injection (Biological)
GR2002 injection 4
GR2002 injection dose 3/Placebo，multiple-dose，Subcutaneous，low frequency
干预措施: GR2002 injection (Biological)
结局指标
主要结局
Adverse events (AEs)
时间窗: Within 20 weeks
Incidence of AEs.
次要结局
- IGA Response(Within 20 weeks)
- EASI 50/75/90 Response(Within 20 weeks)
- immunogenicity(Within 20 weeks)
- Proportion of Subjects With Weekly Mean Reduction in Daily Peak Pruritus NRS of ≥4/≥3(Within 20 weeks)
- Pharmacokinetics parameters(Within 20 weeks)
- Percentage change in BSA score(Within 20 weeks)