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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score
研究概览
简要总结
The main aim of the study is to evaluate the effect of LAD603 in adult participants with severe to very severe alopecia areata (AA). The study will also evaluate the safety, pharmacokinetics (PK), immunogenicity and pharmacodynamic (PD) biomarkers of LAD603.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is a male or female between 18 and 65 years old at the time of signing the informed consent.
- •Severe to very severe AA criteria:
- •Greater than or equal to (>=) 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.
- •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
- •AA, Skin Specific, and Other Inflammatory Diseases
- •Participants have other types of alopecia (including but not limited to traction, scarring alopecia).
- •Participants with "diffuse" type AA.
- •Currently has an active form of other inflammatory skin disease(s) or evidence of skin condition (e.g., 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.
- •Other Medical Conditions
- •Participant has previous severe adverse reaction to subcutaneously administered medication.
- •Participant has any of the following liver safety laboratory results at Screening
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to (>=) 2.5 × upper limit of normal (ULN)
- •Total bilirubin (TBL) >=1.5 × ULN (TBL >=3 × ULN in participants with Gilbert's syndrome)
- •Alkaline phosphatase (ALP) >=1.5 × ULN
- •Prior/Concomitant Therapy
- •Intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication.
研究组 & 干预措施
LAD603 Dose A
Participants will receive LAD603 Dose A , Subcutaneous (SC) injection from Day 1 up to 28 weeks.
干预措施: LAD603 (Drug)
LAD603 Dose B
Participants will receive LAD603 Dose B, SC injection from Day 1 up to 28 weeks.
干预措施: LAD603 (Drug)
Placebo for LAD603
Participants will receive Placebo for LAD603 SC injection from Day 1 up to 28 weeks.
干预措施: Placebo (Other)
LAD603 Dose C
Participants will receive LAD603 Dose C, SC injection from Day 1 up to 28 weeks.
干预措施: LAD603 (Drug)
结局指标
主要结局
Percent Change from Baseline in the Severity of Alopecia Tool (SALT) Score
时间窗: Baseline, Week 28
The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).
次要结局
- Percentage of Participants Achieving a ClinRO for Eyebrow Hair Loss of 0/1(At Week 28)
- Percentage of Participants Achieving an Absolute SALT Score Less than or Equal to (<=) 10/20(At Week 28)
- Percentage of Participants Achieving a Clinician-Reported Outcome (ClinRO) for Eyelash Hair Loss of 0/1(At Week 28)