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NCT05723198 · ClinicalTrials.gov registry record · Phase 3

A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

A Phase 3 study of Skin Diseases and Alopecia, sponsored by Eli Lilly and Company.

Recruiting
Registry status
Phase 3
Development phase
595
Enrollment target
20
Study locations

NCT05723198: Recruiting Phase 3 study of Skin Diseases and Alopecia, sponsored by Eli Lilly and Company.

NCT05723198 is a Phase 3 study of Skin Diseases and Alopecia that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 595 participants, above the 167-participant average among 14 other Skin Diseases trials with a reported enrollment target (256% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05723198, a Phase 3 study of Skin Diseases and Alopecia, is actively recruiting participants, sponsored by Eli Lilly and Company.

RECRUITING
Registry status
Phase 3
Development phase
595 participants
Enrollment target
20
Study locations

Study Summary

The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age. The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind Treatment Period, an approximately 2-year Long-term Extension Period, and a 4-week Post-treatment Follow-up period.

Interventions

  • DRUG Placebo
  • DRUG Baricitinib

Study Locations (20)

Florida

  • Skin Care Research, Inc - Boca Raton
  • Florida Academic Centers Research and Education, LLC - Coral Gables
  • D&H Doral Research Center LLC - Doral
  • Skin Care Research, Inc - Hollywood
  • Solutions Through Advanced Research, Inc. - Jacksonville
  • University of Miami Miller School of Medicine - Miami
  • Pediatric Skin Research, LLC - Miami

California

  • California Dermatology & Clinical Research Institute - Encinitas
  • Dermatology Research Associates - Los Angeles
  • University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology - San Diego
  • The Permanente Medical Group, Inc. - San Francisco
  • Southern California Dermatology, Inc. - Santa Ana

Alabama

  • Total Skin and Beauty Dermatology Center, PC - Birmingham
  • University of Alabama at Birmingham - Birmingham

Illinois

  • Northwestern University - Chicago
  • Northshore University Healthsystem - Skokie

Arizona

  • Investigate MD - Scottsdale

Connecticut

  • Dermatology Physicians of Connecticut - Fairfield

Georgia

  • Skin Care Physicians of Georgia - Macon

Indiana

  • Dawes Fretzin Clinical Research Group, LLC - Indianapolis

Trial Details

FieldValue
Enrollment Target 595 participants
Start Date 2023-02-27
Est. Completion 2029-08
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What NCT05723198 shows while recruiting

NCT05723198 is an interventional study that assigns participants to a tested intervention. The registered 595 participants enrollment target is mid-sized for trials with a published cap, above the 167-participant average among 14 other Skin Diseases trials with a reported enrollment target (256% higher).

The record links to 6 conditions, with Skin Diseases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05723198 names 20 study sites across 8 states, led by Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT05723198 about?

NCT05723198 is a clinical study titled "A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata". The main purpose of this study is to determine the efficacy and safety of baricitinib for the treatment of severe or very severe alopecia areata (hair loss) in children from 6 years to less than 18 years of age. The study is divided into 4 periods, a 5-week Screening period, a 36-week Double-Blind ...

What is the current status of trial NCT05723198?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 595 participants. The study started on 2023-02-27. Estimated completion is 2029-08.

What conditions does trial NCT05723198 study?

This clinical trial studies the following conditions: Skin Diseases, Alopecia, Pathological Conditions, Anatomical, Hypotrichosis, Hair Diseases.

What interventions are being tested in trial NCT05723198?

The interventions under investigation include: Placebo (DRUG), Baricitinib (DRUG).

Who is sponsoring clinical trial NCT05723198?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05723198 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Skin Diseases

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05723198's enrollment target sits among peer trials

595 2nd of 14 the highest of 14 other Skin Diseases trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Skin Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05723198, the US trial registry maintained by the National Library of Medicine. NCT05723198 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.