A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Atopic Dermatitis
- Sponsor
- AbbVie
- Enrollment
- 99
- Locations
- 25
- Primary Endpoint
- Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
Pediatric atopic dermatitis (AD), also known as childhood eczema, is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to assess the change in disease activity (Efficacy) and to assess the safety of upadacitinib in combination with topical corticosteroids (TCS) in pediatric participants 2 to 11 years of age in Japan with moderate to severe AD who are candidates for systemic therapy.
Upadacitinib is approved for the treatment of moderate to severe AD in adults and adolescents 12 years of age and older in many countries, including Japan. This study comprises a 35-day screening period; a 12-week, randomized, double-blind treatment period where there will be a 1 in 2 chance that a participant is assigned placebo. This will be followed by an open-label upadacitinib treatment period up to Week 52.
Around 98 participants will be enrolled in the study at approximately 35 sites in Japan.
Participants will receive upadacitinib oral tablets, or matching placebo, once daily (or an adult equivalent oral solution dose twice a day) for up to 52 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by clinical assessments, blood tests, checking for side effects and completing questionnaires.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A minimum weight of 10 kg and weight and height ≥ -2.0 SD for their age according to Japanese standard growth charts at the Baseline visit.
- •Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to Baseline.
- •Eczema Area and Severity Index (EASI) score ≥ 16; validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score ≥ 3; ≥ 10% body surface area (BSA) of AD involvement at the Baseline visit; and Baseline weekly average of daily WIS or WSI-NRS ≥
- •Participant has applied a topical, additive-free, bland emollient or moisturizer twice daily for at least 7 days before the Baseline visit.
- •Documented history (within 6 months of the Baseline visit) of inadequate response or intolerance to topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) or a systemic immunomodulating therapy, or medical inadvisability of available systemic therapy (e.g., because of important side effects or safety risks).
Exclusion Criteria
- •Participants that have current and/or history of other active skin diseases (e.g., psoriasis or Netherton syndrome or lupus erythematosus) or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit or that would interfere with the appropriate assessment of AD lesions.
- •Participants that have used topical treatments for AD (except for topical emollient or moisturizer treatments) including but not limited to TCS, TCI, or topical PDE-4 inhibitors, within 7 days of the Baseline visit or any the following prohibited AD treatments within the specified timeframes below prior to the Baseline visit:
- •Systemic therapy for AD, including but not limited to corticosteroids and cyclosporine, within 4 weeks;
- •Targeted biologic treatments within 5 half-lives (if known) or within 12 weeks, whichever is longer;
- •Phototherapy treatment, laser therapy, tanning booth use, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
Arms & Interventions
Placebo / Upadacitinib + Topical Corticosteroids (TCS)
Participants will receive placebo orally once a day (QD) in combination with TCS for 12 weeks in the double-blind treatment period. At Week 12 participants will then be switched to receive open-label upadacitinib daily adult equivalent dose in combination with TCS.
Intervention: Placebo
Placebo / Upadacitinib + Topical Corticosteroids (TCS)
Participants will receive placebo orally once a day (QD) in combination with TCS for 12 weeks in the double-blind treatment period. At Week 12 participants will then be switched to receive open-label upadacitinib daily adult equivalent dose in combination with TCS.
Intervention: Upadacitinib
Upadacitinib + Topical Corticosteroids (TCS)
Participants will be randomized to receive the upadacitinib daily adult equivalent dose in combination with TCS once a day (QD) during the double-blind and open label treatment periods for a total of 52 weeks
Intervention: Upadacitinib
Outcomes
Primary Outcomes
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
Time Frame: At Week 12
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], An EASI 75 response is defined as a 75% reduction (improvement) from Baseline in EASI score.
Number of Participants With Adverse Events
Time Frame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 56 weeks)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Secondary Outcomes
- Percentage of participants achieving validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) 0/1 with a reduction from Baseline of ≥ 2 points(At Week 12)
- Percentage of participants achieving an improved (reduced) weekly average Worst Scratch/Itch numerical rating scale (WIS-NRS) score of ≥ 4 from Baseline for participants less than 6 years old with a weekly average WIS of ≥ 4 at Baseline(At Week 12)
- Percentage of participants achieving an improved (reduced) weekly average Worst Itch Scale (WIS) score of ≥ 4 from Baseline for participants equal or greater than 6 years old with a weekly average WIS of ≥ 4 at Baseline(At Week 12)