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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04895423
• Other study ID #: 04532781
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 25, 2021
• Est. completion date: July 25, 2023

Study information

• Verified date: May 2021
• Source: National Medical Research Center for Children's Health, Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Methotrexate therapy
Methotrexate subcutaneously 10-15 mg/m2 once every 7 days within 12 months
• Mycophenolate mofetil therapy
Mycophenolate mofetil per os 500-700 mg/m2 2 times a day within 12 months
• Cyclosporine therapy
Cyclosporine per os 3 mg/m2 2 times a day within 12 months
• 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.

Locations

Country	Name	City	State
Russian Federation	National Medical Research Center for Children's Health	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORAD (Scoring of Atopic Dermatitis)	change of the SCORAD index	screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Primary	NRS (Numeric rating scale for itch)	change of the NRS	screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Primary	Adverse events	Adverse events monitoring	screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Secondary	CDLQI (The Children's Dermatology Life Quality Index)	change of the CDLQI	screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Secondary	POEM (Patient-Oriented Eczema Measure)	change of the POEM	screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Secondary	CSMS (Combined Symptom and Medication Score)	change of the CSMS	screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Secondary	VAS (Visual Analog Scale)	change of the VAS	screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Secondary	ACT (Asthma Control Test)	change of the ACT	screening (baseline), 3, 4, 6 and 12 months from the start of therapy
Secondary	Concentration in the biochemical blood test of total IgE and specific IgE for food and household allergens	change in the Concentration in the biochemical blood test of total IgE, specific IgE-method ImmunoCap to food and household allergens	screening (baseline), 3, 4, 6 and 12 months from the start of therapy