A Randomized Controlled Study of the Efficacy and Safety of Proactive Treatment with Delgocitinib Ointment in the Maintenance of Remission in Atopic Dermatitis

JRCT ID: jRCTs031230314

Registered date:29/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 02/11/2023
• Target sample size: 200
• Study type: Interventional

Intervention(s)

(1) Delgocitinib ointment group
Delgocitinib ointment is applied twice a week, twice a day, in the morning and at night. Delgocitinib ointment should be applied for 24 weeks.
Delgocitinib ointment should be applied for 24 weeks. Moisturizers should be applied continuously.
(2) White Vaseline group
White Vaseline should be applied twice a week, twice a day, in the morning and at night. (2) White Vaseline group: Apply white Vaseline twice a day, twice a week, in the morning and at night.
The duration of application of white Vaseline should be 24 weeks. Moisturizers should be applied continuously.

Outcome(s)

• Primary Outcome: Cumulative number of days with vIGA scores of 0 and 1

Secondary Outcome

(1) Number of days to first relapse
(2) Number of relapse
(3) Number of relapses
(4) EASI score
(5) vIGA score
(6) pNRS
(7) ADCT score
(8) POEM score
(9) PtGA score

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Induction phase of remission
1) Japanese patients diagnosed with atopic dermatitis by the time of consent based on the diagnostic criteria for atopic dermatitis (Hanifin & Rajka)
2) Patients who are at least 6 months of age at the time of consent and capable of making outpatient visits
3) Patients with a vIGA score of 2 (mild disease) or higher at Visit 1
4) Patients with a skin rash area that can be treated with 5 g of topical drug per dose (10 g per day) on Visit 1.

Remission Maintenance Phase
Patients with a vIGA score of 0 (no symptoms) or 1 (almost no symptoms) at the completion of induction of remission

Exclude criteria

Induction phase of remission
Patients who violate the following criteria will be excluded from the investigation to be conducted during Visit 1.
1) Patients with active infection at the site where the investigational drug is to be administered during Visit 1
2) Patients with the following complications on Visit 1
Kaposi's varicella-like rash
Scabies
Molluscum contagiosum
Impetigo contagiosa
Psoriasis
Diseases presenting with ichthyosis erythroderma (Netherton's syndrome)
Collagen diseases (SLE and dermatomyositis)
Contact dermatitis
Skin diseases at the site where the investigational drug is to be applied that may affect the evaluation
3) Patients scheduled to start allergen immunotherapy or oral immunotherapy or those currently receiving these therapies scheduled to increase the dose
4) Patients who used the following drugs within 24 weeks prior to Visit 1
Biological agents (cytokine agents, antibody drugs, etc.)
5) Patients who used the following drugs within 28 days prior to Visit 1
Systemic corticosteroids (oral, injectable, suppository and inhalant)
Systemic immunosuppressive drugs (cyclosporine, methotrexate, oral JAK inhibitors, etc.)
6) Patients who received the following therapies within 28 days prior to Visit 1
Phototherapy (UVB, Narrow-band UVB, PUVA, etc.)
7) Patients with serious complications of the brain, liver, kidney, heart, lungs, digestive organs, blood, endocrine system, metabolic system, or mental system
8) Patients with a history of severe drug allergy such as anaphylactic shock
9) Patients with a history of drug or alcohol dependence
10) Patients who have participated in other research or clinical studies involving medical devices or interventions within 12 weeks prior to Visit 1
11) Patients with a history of adverse reactions to delgocitinib ointment
12) Other research subjects who are judged to be inappropriate as research subjects by the principal investigator or subinvestigator.

Remission maintenance phase
1) Research Subjects who discontinued during the induction phase of remission or who developed serious adverse events or illnesses
2) Other Research Subjects who are deemed inappropriate as Research Subjects by the Principal Investigator or the Attending Investigator

Related Information

• Primary Sponsor: Fujisawa Takao
• Secondary Sponsor: Saeki Hidehisa,Torii Pharmaceutical Co.,Ltd