Evaluation of the Effectiveness and Safety of Immunosuppressive and Biological Therapy of Atopic Dermatitis in Childhood

NCT04895423 | Unknown Phase 4

• 1 other identifier: 04532781
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This comparative study analyzes the efficacy and safety of treatment of children from 6 years of age suffering from moderate to severe atopic dermatitis using an inhibitor of IL4, IL13 and classical immunosuppressants.

Conditions

Atopic Dermatitis

Keywords

Glucocorticoids; Biologic Drugs; Methotrexate; Cyclosporine; dupilumab

Outcome Measures

Primary Outcomes (3)

• SCORAD (Scoring of Atopic Dermatitis)

  change of the SCORAD index

  screening (baseline), 3, 4, 6 and 12 months from the start of therapy

• NRS (Numeric rating scale for itch)

  change of the NRS

  screening (baseline), 3, 4, 6 and 12 months from the start of therapy

• Adverse events

  Adverse events monitoring

  screening (baseline), 3, 4, 6 and 12 months from the start of therapy

Secondary Outcomes (6)

• CDLQI (The Children's Dermatology Life Quality Index)

  screening (baseline), 3, 4, 6 and 12 months from the start of therapy

• POEM (Patient-Oriented Eczema Measure)

  screening (baseline), 3, 4, 6 and 12 months from the start of therapy

• CSMS (Combined Symptom and Medication Score)

  screening (baseline), 3, 4, 6 and 12 months from the start of therapy

• VAS (Visual Analog Scale)

  screening (baseline), 3, 4, 6 and 12 months from the start of therapy

• ACT (Asthma Control Test)

  screening (baseline), 3, 4, 6 and 12 months from the start of therapy

Study Arms (4)

Group №1: Methotrexate therapy

EXPERIMENTAL

Drug: Methotrexate therapy

Group №2: Mycophenolate mofetil therapy

EXPERIMENTAL

Drug: Mycophenolate mofetil therapy

Group №3: Cyclosporine therapy

EXPERIMENTAL

Drug: Cyclosporine therapy

Group №4: Dupilumab therapy

EXPERIMENTAL

Drug: Dupilumab therapy

Interventions

Methotrexate therapy DRUG

Methotrexate subcutaneously 10-15 mg/m2 once every 7 days within 12 months

Group №1: Methotrexate therapy

Mycophenolate mofetil therapy DRUG

Mycophenolate mofetil per os 500-700 mg/m2 2 times a day within 12 months

Group №2: Mycophenolate mofetil therapy

Cyclosporine therapy DRUG

Cyclosporine per os 3 mg/m2 2 times a day within 12 months

Group №3: Cyclosporine therapy

Dupilumab therapy DRUG

Patients weighing \<30 kg received an initial dose of 600 mg (2 injections of 300 mg subcutaneously), then 300 mg every 4 weeks. Patients weighing 30 to \<60 kg received an initial dose of 400 mg (2 injections of 200 mg subcutaneously), then 200 mg every 2 weeks; Patients weighing 60 kg or more, the initial dose is 600 mg (2 injections of 300 mg subcutaneously), then 300 mg every 2 weeks.

Group №4: Dupilumab therapy

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age over 6 years inclusive;
• Atopic dermatitis diagnosed at least 12 months before the start of the study;
• Atopic dermatitis of moderate or severe course;
• Consent to discontinue the use of the following prohibited drugs or any of the following therapies at least 4 weeks before the start of the study and not to use them throughout the study, unless otherwise specified below:
• Oral systemic corticosteroids;
• Other systemic immunosuppressive drugs;
• Phototherapy, including therapeutic phototherapy (psoralen plus ultraviolet A, ultraviolet B), excimer laser, and self-medication using a tanning bed;
• A signed and dated informed consent received from the patient's parents (guardians), as well as from a patient over 14 years of age, to participate in the study.
• Ability to attend control visits within the specified time frame

You may not qualify if:

• Use of other genetically engineered biological preparations in therapy;
• Participation in other clinical trials;
• The presence of other concomitant skin diseases in the present or in the past, which could affect the assessment of the effect of the study drugs on the course of atopic dermatitis;
• The presence of herpetic eczema within 12 months before the start of the study;
• A history of two or more cases of herpetic eczema;
• The presence in the present of a skin infection for which is required or is being treated with antibiotics for topical use or systemic antibiotics;
• Therapy with the following drugs:
• Other genetically engineered biological preparations less than 5 half-lives before the start of the study.
• Any corticosteroid for oral and parenteral administration and administration, which were in therapy for 2 weeks before enrollment in the study, or the possible need for parenteral injection of corticosteroids during the course of the study.
• Intra-articular corticosteroid injection within 2 weeks prior to study enrollment; Note: The use of intranasal or inhaled steroids is permitted throughout the study.
• Extensive or complete disability, significantly limiting personal care or determining the inability to carry it out.
• Immunodeficiency disease;
• The presence in the past or present of any serious and / or unstable disease, which, in the opinion of the investigator, may pose an unacceptable risk to the patient in the case of the use of the investigational drug or interfere with the interpretation of the data;
• History of lymphoproliferative disease; or manifestations or symptoms suggesting the possible presence of lymphoproliferative disease, including lymphadenopathy or splenomegaly; either primary or recurrent malignant disease in active form; or remission after a clinically significant malignant disease lasting less than 5 years;
• The course of a viral, bacterial, fungal or parasitic infection;

Sponsors & Collaborators

• National Medical Research Center for Children's Health, Russian Federation: lead

Study Sites (1)

National Medical Research Center for Children's Health

Moscow, 119296, Russia

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: November 25, 2021
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: May 20, 2021

Record last verified: 2021-05

Locations

RU (1)