Clinical Trials List
2023-07-01 - 2029-08-10
Phase III
Recruiting6
ICD-10L63.2
Ophiasis
ICD-10L63.8
Other alopecia areata
ICD-10L63.9
Alopecia areata, unspecified
ICD-9704.01
Alopecia areata
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
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Trial Applicant
ICON Clinical Research Pte Ltd
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chih-Chieh Chan 無
- 陳柏樺 無
- 戴仰霞 無
- 黃常銘 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- DINGDAR LEE 無
- 吳貞宜 無
- Cheng-Yuan Li 無
- Yun-Ting Chang 無
- 何翊芯 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chung-Yao Hsu 無
- 吳明頴 無
- Chun-Wei Lu 無
- Chun-Bing Chen 無
- Chin-Yi Yang 無
- 紀敏慧 無
- I-Hsin Shih 無
- 黄毓惠 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Baricitinib
Baricitinib
Dosage Form
Dosage
2mg
4mg
Endpoints
Inclution 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.
The Estimated Number of Participants
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Taiwan
27 participants
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Global
595 participants
