|
| Overall Recruitment Status: Active, currently enrolling |
| |
| Official Title |
| A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years to Less than 18 Years of Age with Alopecia Areata |
| |
| Region |
Sponsors |
| California - Northern |
|
| |
| Acronym |
NCT No. |
| BRAVE-PEDS |
NCT05723198 |
| |
| Study Type |
Phase |
| Clinical Trial |
|
| |
| Purpose |
| The purpose of the BRAVE-PEDS 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.
|
| |
| Detailed Description |
| Study I4V-MC-JAIO (JAIO) is a Phase 3, placebo-controlled, randomized, double-blind study evaluating the efficacy, safety, and PK of baricitinib in children from 6 years to less than 18 years of age with alopecia areata (AA).
The primary objective of this study is to demonstrate the superiority of baricitinib low dose or high dose compared to placebo in the intent-to-treat population of children and adolescents with AA. 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). The benefit/risk for adolescents will be established prior to enrollment of children. Data from the adolescent cohort through at least 52weeks will be submitted to FDA for review and comment prior to the enrollment of children ages 6 years to ?12 years in the USA.
|
| |
| |
| |
- 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.
|
-
History of trial and failure with at least 1 available treatment (topical or other) for AA.
|
-
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.
|
|
| |
|
|
| |
|