Alopecia Areata
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Alopecia Areata
16875 Enrolling

Alopecia Areata – Patchy Baldness Clinical Trial (33 Months)


Treatment: Oral Age: 6 Years



Participating Locations

COUNTRY
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United States
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Canada

Participating Experts

Dr. Melinda Gooderham

Dermatologist

Dr. Sameh Hanna

Dermatologist

Dr. Chih-ho Hong

Dermatologist

Dr. Charles Lynde

Dermatologist

Dr. G. Daniel Schachter

Dermatologist

Dr. Matthew Zirwas

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: February 25, 2024

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

ClinicalTrials.gov ID

NCT05723198

Sponsor

Eli Lilly and Company

Study Description

  • Brief 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.

  • Condition or Disease:

    Areata Alopecia

  • Intervention/Treatment:

    Drug: Baricitinib
    Drug: Baricitinib
    Drug: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    6 Years and 17 Years (Child)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

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).
Have severe areata alopecia (AA) for at least 1 year
Diagnosis for at least 1 year
Current AA episode of at least 6 months’ duration
SALT score ≥50% at screening and baseline
History of trial and failure with at least 1 available treatment (topical or other) for AA
History of psychological counseling related to AA

Current episode of severe AA of less than 8 years.

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.

Exclusion Criteria:

Primarily “diffuse” type of AA (characterized by diffuse hair shedding).
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.
Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
Have uncontrolled arterial hypertension
Have had major surgery within 8 weeks prior to screening or will require major surgery during the study
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.
Have a positive test for hepatitis B virus (HBV) infection
Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid [RNA]).
Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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