Efficacy of Delgocitinib ointment and topical corticosteroids combination therapy in pediatric patients with atopic dermatitis in remission induction

JRCT ID: jRCTs031240119

Registered date:27/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 27/05/2024
• Target sample size: 150
• Study type: Interventional

Intervention(s)

- Application of the study drug
To compare the two application methods, the study subjects will be equally assigned to one of the application methods according to the predetermined allocation procedure.
1) Hydrocortisone butyrate ointment + white petrolatum multilayer application group
2) Hydrocortisone butyrate ointment + delgocitinib ointment 0.5% multilayer application group

- Standard visit date
Visits are scheduled once every 2 weeks until 4 weeks after the start of the study drug application.

Outcome(s)

• Primary Outcome: Change rate of EASI score at the final assessment (after 4 weeks of treatment or at the time of discontinuation)

Secondary Outcome

- EASI score for each Visit
- Achievement percentage of EASI-50, EASI-75, EASI-90, EASI-100 for each Visit
- vIGA score for each Visit
- Achievement percentage of vIGA 0 or 1 for each visit, Achievement percentage of vIGA 0 or 1 and [improvement of 2 or more levels]
- Percentage of Body surface area (BSA) of the inflammatory rash for each Visit
- Numeric Rating Scale (NRS) score of atopic dermatitis for each Visit
- Percentage of study subjects with improvement of 3 or more and 4 or more points from baseline in NRS score for atopic dermatitis for each Visit
- Patient-Oriented Eczema Measure (POEM) for each Visit
- Percentage of study subjects with decrease of 4 or more points from baseline in POEM for each Visit

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: < 16age old
• Gender: Both

Include criteria

(1) Japanese Patients diagnosed with atopic dermatitis based on Hanifin and Rajka diagnostic criteria prior to the time of informed consent.
(2) Patients with age between 2 and 15 years old at the time of informed consent who can visit the study site as an outpatient.
(3) Patients whose Eczema Area and Severity Index (EASI) score of Visit 1 (start of screening) and Visit 2 (start of treatment) is between 7.1 (moderate) and 50.0 (severe).
(4) Patients with a skin eruption area with inflammation that can be treated using a topical agent (5g per application) upon Visit 1 and Visit 2.
(5) Patients whose validated Investigator Global Assessment (hereinafter referred to as "vIGA") score as determined by a physician is 2 or greater upon Visit 1 and Visit 2.
(6) Patients who can receive multilayer application of trial drug from Visit 2 to Visit 4 (after 4 weeks of treatment) or to the end of the study.

Exclude criteria

(1) Patients with active infection where study drug is to be applied upon Visit 2.
(2) Patients with the following diseases upon Visit 2.
- Kaposi's varicelliform eruption
- Scabies
- Molluscum contagiosum
- Contagious impetigo
- Psoriasis
- Ichthyosiform erythroderma (Netherton syndrome)
- Collagen diseases (systemic lupus erythematosus and dermatomyositis)
- Contact dermatitis
- Skin diseases at the application Site of Study drug that influence assessment
(3) Patients whose condition is not stable while undergoing allergen immunotherapy upon Visit 2.
(4) Patients who have received biological drugs (cytokine preparations, antibody drugs, etc.) within 24 weeks before Visit 2.
(5) Patients who have used the following drugs upon Visit 2.
- Systemic-acting corticosteroid preparations (oral, injectable, and suppository)
- Topical corticosteroid drugs (Group I or II)
- Systemic immunosuppressive drugs (cyclosporine, methotrexate, oral Janukinase inhibitors, etc.)
(6) Patients who have received phototherapy (Ultraviolet Light-B (hereinafter referred as "UVB"), narrow-band UVB, Psoralen Long Wavelength Ultraviolet Light (PUVA), etc. and including laser therapy) within 28 days before Visit 2.
(7) Patients who have used the following drugs within 7 days before Visit 2.
- Topical corticosteroid drugs (Group III)
- Analgesics, antipruritics, and topical agents with anti-inflammatory properties (NSAID, etc.) used for the application site of the study drug.
- Drugs intended for the treatment of atopic dermatitis other than Topical corticosteroid drugs (Group IV or V), tacrolimus hydrate ointment, delgositinib ointment, and difamilast ointment
Note: Antihistamines and antiallergic drugs can be used only if the dosage is not changed during this study.
Note: Moisturizers and protective agents (white petroleum jelly: Only on areas other than the inflamed skin rash area [the application site of the study drug], heparin analogues, urea, zinc oxide) can be used.
(8) Patients with serious complications of the brain, liver, kidney, heart, lungs, digestive organs, hematology, endocrine system, metabolic system, and psychiatric system, etc.
(9) Patients with a history of serious drug allergies such as anaphylactic shock
(10) Patients with a history of drug dependence
(11) Patients who have participated in another clinical trials or clinical research with interventions involving medical devices within 12 weeks before Visit 2.
(12) Patients with a history of side effects to delgocitinib ointment and hydrocortisone butyrate ointment, and who are expected to develop side effects if reapplied.
(13) Other; study subjects who are judged to be inappropriate as study subjects by the principal investigator or sub investigator.

Related Information

• Primary Sponsor: Yoshihara Shigemi
• Secondary Sponsor: Torii Pharmaceutical CO.,LTD.