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Studies

Interventional Recruiting Phase 2

NCT07533006 on ClinicalTrials.gov

A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)

Official title: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Severe Alopecia Areata

  • Sponsor: Eli Lilly (Group)
  • Enrollment: 65 (Estimated)
  • Study start: 2026-04-14 (Actual)
  • Primary completion: 2027-06-01 (Estimated)
  • Study completion: 2027-10-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Double (Participant, Investigator)
  • PrimaryPurpose: Treatment

Brief Summary

The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, and how well it's tolerated and what side effects may occur. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

The study drug will be administered intravenously (IV) (into a vein in the arm).

The study will last approximately 48 weeks, including screening.

Conditions

  • Alopecia Areata

Intervention / Treatment

  • Drug: LY4005130
  • Drug: Placebo

Primary Outcome Measures

  • Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Less than or Equal to (≤) 20 (Week 24)

Countries

Canada, China, Netherlands, Poland, South Korea, United Kingdom, United States

Locations and Investigators

  • Center For Dermatology Clinical Research, Inc., Fremont, United States (Recruiting)
    • Sunil Dhawan (Principal Investigator)
  • Northridge Clinical Trials, Northridge, United States (Recruiting)
    • Navid Ezra (Principal Investigator)
  • Cura Clinical Research - Santa Clarita - Kelly Johnson Parkway, Santa Clarita, United States (Recruiting)
    • Bernard Raskin (Principal Investigator)
  • Health Clinical Research, LLC, Cutler Bay, United States (Recruiting)
    • Soroush Aghigh (Principal Investigator)
  • Brigham and Women's Hospital, Boston, United States (Recruiting)
    • Arash Mostaghimi (Principal Investigator)
  • Revival Research Institute, LLC, Troy, United States (Recruiting)
    • Ali Moiin (Principal Investigator)
  • Stracskin, Portsmouth, United States (Recruiting)
    • Abel Jarell (Principal Investigator)
  • Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue, San Antonio, United States (Recruiting)
    • John Browning (Principal Investigator)
  • Jordan Valley Dermatology & Research Center, South Jordan, United States (Recruiting)
    • Douglass Forsha (Principal Investigator)
  • Kelowna Health and Memory Centre, Kelowna, Canada (Recruiting)
    • Nicola Gray (Principal Investigator)
  • Ryan Clinical Research Inc., Newmarket, Canada (Recruiting)
    • Sanjay Siddha (Principal Investigator)
  • Dar Clinical Research - Ottawa - Hunt Club Road, Ottawa, Canada (Recruiting)
    • Reetesh Bose (Principal Investigator)
  • SIMa Recherche, Verdun, Canada (Recruiting)
    • Simon Nigen (Principal Investigator)
  • Beijing Friendship Hospital Affiliate of Capital University, Beijing, China (Recruiting)
    • Fenglin Zhuo (Principal Investigator)
  • Huashan Hospital, Fudan University, Shanghai, China (Recruiting)
    • Wenyu Wu (Principal Investigator)
  • Shanghai Skin Disease Hospital, Shanghai, China (Recruiting)
    • Yuling Shi (Principal Investigator)
  • Tianjin Medical University General Hospital, Tianjin, China (Recruiting)
    • Huiping Wang (Principal Investigator)
  • Erasmus Medisch Centrum, Rotterdam, Netherlands (Recruiting)
    • Rick Waalboer-Spuij (Principal Investigator)
  • Centrum Badan Klinicznych PI-House sp. z o.o., Gdansk, Poland (Recruiting)
    • Aleksandra Okuniewska (Principal Investigator)
  • Diamond Clinic, Krakow, Poland (Recruiting)
    • Barbara Rewerska (Principal Investigator)
  • Dermedic Jacek Zdybski, Ostrowiec ÅšwiÄ™tokrzyski, Poland (Recruiting)
    • Jacek Zdybski (Principal Investigator)
  • Centrum Medyczne Ginemedica, Wroclaw, Poland (Recruiting)
    • Justyna Kwapisz (Principal Investigator)
  • Chung-Ang University Hospital, Dongjak-gu, South Korea (Recruiting)
    • Beomjoon Kim (Principal Investigator)
  • Inha University Hospital, Incheon, South Korea (Recruiting)
    • Gwang Seong Choi (Principal Investigator)
  • Jeonbuk National University Hospital, Jeonju, South Korea (Recruiting)
    • Jin Park (Principal Investigator)
  • Seoul National University Hospital, Seoul, South Korea (Recruiting)
    • OHSANG KWON (Principal Investigator)
  • Kyung Hee University Hospital at Gangdong, Seoul, South Korea (Recruiting)
    • Bark Lynn Lew (Principal Investigator)
  • Royal London Hospital, London, United Kingdom (Recruiting)
    • Maria Angeliki Gkini (Principal Investigator)
  • Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom (Not yet recruiting)
    • Leila Asfour (Principal Investigator)
  • Salford Royal Hospital, Salford, United Kingdom (Recruiting)
    • Matthew Harries (Principal Investigator)

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) (Study Director) — Eli Lilly and Company