CTRI/2025/11/097238
Not yet recruiting
Phase 3
A 16-Week, Multicenter, Interventional, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Investigate Efficacy and Safety of Abrocitinib in Children 6 To Less Than 12 Years of Age with Moderate-To-Severe Atopic Dermatitis
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Pfizer Inc.
- Enrollment
- 150
- Locations
- 4
- Primary Endpoint
- 1. Response based on achieving Validated Investigators Global Assessment score of clear or almost clear and a reduction from baseline of greater than equal to 2 points at Week 12
Overview
Brief Summary
This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to less than 12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 6.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria Children aged 6 to less than 12 years at the time of informed consent or assent.
- •No contraception methods are required for male participants. Disease Characteristics- Participants who meet all of the following AD criteria-
- •A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria and
- •A diagnosis of moderate-to-severe AD at the baseline visit.
- •must fulfill all of the following criteria- BSA greater than equal to 10 percent, vIGA greater than equal to 3, EASI greater than equal to 16, and WI-NRS greater than equal to 4 and
- •Documented history within 6 months of the screening visit of inadequate response to treatment with topical medical therapy for AD eg, TCS and TCI, for at least 4 weeks and are candidates for systemic therapy.
Exclusion Criteria
- •Participants are excluded from the study if any of the following criteria apply- Medical Conditions-
- •Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigators judgment, make the participant inappropriate for the study.
- •If the participant has SDQ total score greater than equal to 17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study.
- •A copy or summary of the evaluation should be placed in the site source documents.
- •Have any of the following medical conditions- i) Infections- Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline) or have superficial skin infections within 1 week of Day
- •History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day
- •Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
- •Infection with HIV, hepatitis B, and/or hepatitis C Evidence of active TB or inadequately treated latent TB.
- •ii) Skin Conditions- Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.
- •iii) Other Conditions- Documented history of skeletal dysplasia.
Outcomes
Primary Outcomes
1. Response based on achieving Validated Investigators Global Assessment score of clear or almost clear and a reduction from baseline of greater than equal to 2 points at Week 12
Time Frame: 1. At Week 12 | 2. At week 12
2. Response based on achieving greater than 75 percent improvement from baseline in the Eczema Area and Severity Index at Week 12
Time Frame: 1. At Week 12 | 2. At week 12
Secondary Outcomes
- Change from Baseline in the Worst Itch Numerical Rating Scale at Week 2(At week 2)
- Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12(At week 12)
- Response based on achieving WI-NRS less than 2 at Week 12(At week 12)
Investigators
Study Sites (4)
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