RECRUITING

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

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Conditions

Areata AlopeciaAlopeciaHypotrichosisHair DiseasesSkin DiseasesPathological Conditions, Anatomical

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

Quick Facts

Study Start:2023-02-27
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05723198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).
  2. * Have severe areata alopecia (AA) for at least 1 year
  3. * Diagnosis for at least 1 year
  4. * Current AA episode of at least 6 months' duration
  5. * SALT score ≥50% at screening and baseline
  6. * History of trial and failure with at least 1 available treatment (topical or other) for AA
  7. * History of psychological counseling related to AA
  8. * Current episode of severe AA of less than 8 years.
  9. * Note: Participants who have severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.
  1. * Primarily "diffuse" type of AA (characterized by diffuse hair shedding).
  2. * Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.
  3. * Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
  4. * Have uncontrolled arterial hypertension
  5. * Have had major surgery within 8 weeks prior to screening or will require major surgery during the study
  6. * Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data.
  7. * Have a positive test for hepatitis B virus (HBV) infection
  8. * Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid \[RNA\]).
  9. * Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
-317-615-4559
ClinicalTrials.gov@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35203
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Investigate MD
Scottsdale, Arizona, 85255
United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
United States
Dermatology Research Associates
Los Angeles, California, 90045
United States
University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
San Diego, California, 92123
United States
The Permanente Medical Group, Inc.
San Francisco, California, 94118
United States
Southern California Dermatology, Inc.
Santa Ana, California, 92701
United States
Dermatology Physicians of Connecticut
Fairfield, Connecticut, 06824
United States
Skin Care Research, Inc
Boca Raton, Florida, 33486
United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134
United States
Pediatric Skin Research, LLC
Coral Gables, Florida, 33146
United States
D&H Doral Research Center LLC
Doral, Florida, 33122
United States
Skin Care Research, Inc
Hollywood, Florida, 33021
United States
Solutions Through Advanced Research
Jacksonville, Florida, 32256
United States
University of Miami Miller School of Medicine
Miami, Florida, 33125
United States
ForCare Clinical Research
Tampa, Florida, 33613
United States
Skin Care Physicians of Georgia
Macon, Georgia, 31217
United States
Northwestern University
Chicago, Illinois, 60611
United States
NorthShore University HealthSystem
Skokie, Illinois, 60077
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
United States
The South Bend Clinic Center for Research
South Bend, Indiana, 46617
United States
DermAssociates PC.
Rockville, Maryland, 20850
United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
United States
Michigan Center for Research Company
Clarkston, Michigan, 48346
United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
United States
Advanced Skin Research Center
Omaha, Nebraska, 68144
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28277
United States
OnSite Clinical Solutions
Charlotte, North Carolina, 28277
United States
Bexley Dermatology Research
Bexley, Ohio, 43209
United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136
United States
Northwest Dermatology Institute
Portland, Oregon, 97210
United States
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, 19341
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
International Clinical Research - Tennessee (IC Research)
Murfreesboro, Tennessee, 37130
United States
Dermatology Treatment and Research Center
Dallas, Texas, 75230
United States
Pediatric Dermatology of North Texas
Grapevine, Texas, 76051
United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
United States
Complete Dermatology
Sugar Land, Texas, 77479
United States
University of Utah MidValley Dematology
Murray, Utah, 84107
United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
United States
University of Wisconsin-Madison
Madison, Wisconsin, 53715
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-27
Study Completion Date2029-08

Study Record Updates

Study Start Date2023-02-27
Study Completion Date2029-08

Terms related to this study

Additional Relevant MeSH Terms

  • Areata Alopecia
  • Alopecia
  • Hypotrichosis
  • Hair Diseases
  • Skin Diseases
  • Pathological Conditions, Anatomical