2025-523342-27-00招募中2 期
A Phase 2, randomized, placebo-controlled, double-blind clinical study to evaluate efficacy and safety of LAD603 in adult subjects with severe to very severe alopecia areata
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 26
- 主要终点
- Percent change from baseline in the SALT score, at Week 28.
研究概览
简要总结
To evaluate the clinical efficacy of LAD603 compared with placebo in adult patients with severe to very severe alopecia areata
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subject is a male or female between 18 and 65 years old at the time of signing the informed consent.
- •Subject is able to understand and willing to comply with study requirements as per Investigator’s opinion.
- •Subject provides written informed consent in accordance with institutional and regulatory guidelines, prior to any study-related procedures being performed.
- •AA criteria: a)Patchy scalp hair loss (including ophiasis or sisaipho variants), alopecia totalis (AT), or alopecia universalis (AU): AT is defined as complete (100%) scalp hair loss. AU is defined as complete (100%) scalp, facial, and body hair loss. b)≥50% hair loss of the scalp as measured by SALT without evidence of terminal hair regrowth within 6 months at both the Screening and Baseline (Day 1) visits. c) Current episode of hair loss lasting at least 6 months and not exceeding 7 years.
- •Participants who are WOCBP or male must agree to the requirements for the avoidance of pregnancy and exposure of the participant’s partner to LAD603 during the study
排除标准
- •Subjects have other types of alopecia (including but not limited to traction, scarring alopecia).
- •Subjects with "diffuse" type AA
- •History of male or female-pattern hair loss (>Hamilton stage III or >Ludwig stage II).
- •Subjects with history or presence of hair transplants.
- •Use of adhesive wigs, other than banded perimeter wigs, during the study.
- •Currently has an active form of other inflammatory skin disease(s) or evidence of skin condition (eg, psoriasis, seborrheic dermatitis, lupus) at the time of the Screening or Baseline (Day 1) visits that is expected to interfere with the assessment of alopecia areata severity. (For the avoidance of doubt, when no interference is expected, subjects could participate if they are otherwise eligible, including adhering to the allowed/permitted medication requirements.)
研究组 & 干预措施
LAD603
Test
干预措施: LAD603 (Drug)
Placebo for LAD603
Placebo
干预措施: Placebo for LAD603 (Drug)
结局指标
主要结局
Percent change from baseline in the SALT score, at Week 28.
Percent change from baseline in the SALT score, at Week 28.
次要结局
未报告次要终点
研究者
Almirall, S.A
Scientific
Almirall S.A.
研究点 (26)
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