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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 (I4V-MC-JAIO)

A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata (I4V-MC-JAIO)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

May. 31, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Have severe areata alopecia (AA) for at least 1 year
Current AA episode of at least 6 months' duration with hair loss encompassing >=50% of the scalp
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.

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.

Both

Areata Alopecia

Drug: Baricitinib
Administered orally
Other Name: LY3009104
Drug: Placebo
Administered orally

[Study Arms]
Experimental: Baricitinib High Dose
Participants will receive baricitinib high dose orally.
Intervention: Drug: Baricitinib
Experimental: Baricitinib Low Dose
Participants will receive baricitinib low dose orally.
Intervention: Drug: Baricitinib
Placebo Comparator: Placebo
Participants will receive placebo
Intervention: Drug: Placebo

Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) <=20 [ Time Frame: Week 36 ]

+81-3-3342-6111

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

United States