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

NCT ID: NCT04895423

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-25
• Study Completion Date: 2023-07-25

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.

Detailed Description

This is a prospective study aimed at direct comparative analysis of the efficacy and safety of treatment of children from 6 years of age suffering from moderate and severe atopic dermatitis using a genetically engineered biological drug and classical immunosuppressants.

Based on clinical and anamnestic data, compliance with the inclusion / exclusion criteria, the study included 160 patients from 6 years old, with moderate / severe atopic dermatitis.

The initial indices were assessed: SCORAD- Scoring of Atopic Dermatitis (index for assessing the severity of atopic dermatitis); NRS- numeric rating scale for itch; CDLQI - The Children's Dermatology Life Quality Index; POEM- Patient-Oriented Eczema Measure (personalized assessment of eczema) and laboratory parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, serum albumin, blood urea specific IgE to food and household allergens, indicators of a clinical blood test, indicators of a general analysis of urine, indicators of a biochemical analysis of urine (creatinine, urea).

In the presence of concomitant allergic pathology (bronchial asthma, allergic rhinitis), the CSMS [Combined Symptom and Medication Score] were additionally assessed (Scale for assessing nasal symptoms of rhinitis, taking into account the need for medication); VAS - Visual Analog Scale (visual analog scale); ACT- Asthma Control Test. Subsequently, systemic therapy was prescribed: metorexat (40 people), mycophenolate mofetil (40 people), cyclosporine (40 people) dupilumab (40 people).

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group №1: Methotrexate therapy

Group Type: EXPERIMENTAL

Methotrexate therapy

Intervention Type: DRUG

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

Group №2: Mycophenolate mofetil therapy

Group Type: EXPERIMENTAL

Mycophenolate mofetil therapy

Intervention Type: DRUG

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

Group №3: Cyclosporine therapy

Group Type: EXPERIMENTAL

Cyclosporine therapy

Intervention Type: DRUG

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

Group №4: Dupilumab therapy

Group Type: EXPERIMENTAL

Dupilumab therapy

Intervention Type: 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.

Interventions

Methotrexate therapy

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

Intervention Type: DRUG

Mycophenolate mofetil therapy

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

Intervention Type: DRUG

Cyclosporine therapy

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

Intervention Type: DRUG

Dupilumab therapy

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age over 6 years inclusive;

2. Atopic dermatitis diagnosed at least 12 months before the start of the study;

3. Atopic dermatitis of moderate or severe course;

4. 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:

1. Oral systemic corticosteroids;

2. Other systemic immunosuppressive drugs;

3. Phototherapy, including therapeutic phototherapy (psoralen plus ultraviolet A, ultraviolet B), excimer laser, and self-medication using a tanning bed;

5. 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.

6. Ability to attend control visits within the specified time frame

Exclusion Criteria

1. Use of other genetically engineered biological preparations in therapy;

2. Participation in other clinical trials;

3. 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;

4. The presence of herpetic eczema within 12 months before the start of the study;

5. A history of two or more cases of herpetic eczema;

6. 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;

7. Therapy with the following drugs:

1. Other genetically engineered biological preparations less than 5 half-lives before the start of the study.

2. 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.

3. Intra-articular corticosteroid injection within 2 weeks prior to study enrollment; Note: The use of intranasal or inhaled steroids is permitted throughout the study.

8. Extensive or complete disability, significantly limiting personal care or determining the inability to carry it out.

9. Immunodeficiency disease;

10. 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;

11. 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;

12. The course of a viral, bacterial, fungal or parasitic infection;

13. Failure or unwillingness of the patient or patient's parent / caregiver / patient legal guardian to comply with the requirements of research participants throughout the study and / or unwillingness to follow research restrictions / procedures, including the use of data loggers.

14. Contraindications to the use of adrenaline.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Medical Research Center for Children's Health

Moscow, , Russia

Countries

Russia

Facility Contacts

Nikolay Murashkin, DMS

Role: primary

m_nn2001@mail.ru

+79184951122

Other Identifiers

04532781

Identifier Type: -

Identifier Source: org_study_id