A Randomized, Double-Blind, Placebo-Controlled Phase 2a Proof-of-Concept Study Evaluating the Safety and Efficacy of ADX-914 in Subjects With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Q32 Bio Inc.
- 入组人数
- 102
- 试验地点
- 24
- 主要终点
- Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest
研究概览
简要总结
This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center proof-of-concept (POC) study in subjects with moderate to severe Atopic Dermatitis.
详细描述
This is a two-part phase IIa, randomized, double-blind, placebo-controlled, multi-center proof-of-concept (POC) study in adult subjects with persistent moderate to severe Atopic Dermatitis (AD). ADX-914 or matching placebo for administered subcutaneously in the clinic setting every 2 weeks for 12 weeks, and follow-up for 12 weeks. ADX-914 or matching placebo will be in the clinic setting post-randomization. In Part A, up to 3 cohorts of subjects will be randomized 2:1 drug vs placebo. In Part B subjects will be randomized 1:1 to drug vs placebo at a doses selected in Part A.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age ≥18 years, inclusive, at time of informed consent, with chronic AD (duration of disease ≥3 years) diagnosed by the Eichenfield revised criteria of Hanifin and Rajka.
- •Moderate to severe disease activity at baseline and screening defined as:
- •BSA affected ≥10%
- •EASI Score ≥12
- •Investigators Global Score (IGA) ≥3
- •Who, in the opinion of the Investigator, have a history of inadequate response to at least one of the following:
- •at least 4-week course of medium-potency topical steroids or other approved topical immunomodulators (calcineurin, PDE-4 and JAK inhibitors)
- •systemic steroids or phototherapy
- •oral chemical synthetic immunomodulators (MTX, mycophenolate mofetil, azathioprine, cyclosporine, systemic approved biologics [dupliumab, ustekinumab or tralokinumab]), or approved systemic targeted synthetic JAK inhibitors (upadacitinib, abrocitinib)
排除标准
- •Body weight ≤ 50.0 kg for men and ≤ 45.0 kg for women and > 120 kg at Screening
- •Rescue therapy, topical or systemic, need anticipated within 4 weeks of randomization
- •Recent (within 2 months of informed consent) or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection
- •A positive QuantiFERON®TB Gold test at Screening or history of tuberculosis (TB)
- •Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to receive a live vaccine during the study
- •Systemic, topical or device-based therapy of AD
- •Serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring
- •Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on atopic dermatitis
- •Other active autoimmune diseases other than those above that would make it difficult to appropriately assess AD disease activity or pose a risk to the subject's participation in the trial
- •Pregnant or lactating women, or women planning to become pregnant or initiate breastfeeding.
- •History of sensitivity to any of the study treatments, or components thereof, or a history of drug or other allergy that, in the opinion of the Investigator, contraindicates their participation.
- •Has been in another investigational trial within 30 days or 5 half-lives of the investigational agent (whichever is greater) prior to the informed consent.
研究组 & 干预措施
ADX-914
干预措施: ADX-914 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest
时间窗: 14 Weeks
Part A and B: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 vs placebo
时间窗: 14 Weeks
Severity score is based on evaluation of severity of atopic dermatitis in 4 body regions (head and neck, trunk, upper limbs, and lower limbs). The minimum score is 0 (less severe) and maximum score is 72 (most severe).
次要结局
- Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score(24 Weeks)
- Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with at least 2 grades of reduction from Baseline(24 Weeks)
- Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score(24 Weeks)
- Proportion of subjects achieving Eczema Area and Severity Index (EASI) reduction of 50%, 75% and 90%(24 Weeks)
- Incidence of adverse events(24 Weeks)