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RECRUITING Phase 3

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

NCT05723198 · View on ClinicalTrials.gov ↗

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

Sponsor

Eli Lilly and Company

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05723198

The ClinicalTrials.gov registry entry for NCT05723198 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 595 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05723198 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05723198?

The interventions under investigation include: Placebo (DRUG), Baricitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05723198?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial