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Atopic DermatitisPhase 4NCT04895423

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

A Phase 4 study testing Methotrexate therapy, Mycophenolate mofetil therapy and Cyclosporine therapy in people with Atopic Dermatitis, run by National Medical Research Center for Children's Health, Russian Federation at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Methotrexate therapy, Mycophenolate mofetil therapy and Cyclosporine therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteRussia
Study dates
25 Nov 2021to 25 Jul 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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;
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  • 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;
  • 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.
  • Contraindications to the use of adrenaline.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • National Medical Research Center for Children's Health

    Moscow, 119296

    Nikolay Murashkin, DMS, +79184951122, m_nn2001@mail.ru

    Mariam Edwardovna

Other trials in Russia

About this study

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.

Read the 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).

Being tested
Methotrexate therapy, Mycophenolate mofetil therapy, Cyclosporine therapy, Dupilumab therapy
Keywords
Glucocorticoids, Biologic Drugs, Methotrexate, Cyclosporine, dupilumab
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methotrexate therapyDrug

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

  • Mycophenolate mofetil therapyDrug

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

  • Cyclosporine therapyDrug

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

  • Dupilumab therapyDrug

    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.

Study groups in NCT04895423
Study groupRoleWhat they receive
Group №1: Methotrexate therapyExperimentalNot described
Receives: Drug: Methotrexate therapy
Group №2: Mycophenolate mofetil therapyExperimentalNot described
Receives: Drug: Mycophenolate mofetil therapy
Group №3: Cyclosporine therapyExperimentalNot described
Receives: Drug: Cyclosporine therapy
Group №4: Dupilumab therapyExperimentalNot described
Receives: Drug: Dupilumab therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SCORAD (Scoring of Atopic Dermatitis)

    change of the SCORAD index

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

  2. NRS (Numeric rating scale for itch)

    change of the NRS

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

  3. Adverse events

    Adverse events monitoring

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

Secondary outcomes (6)

  1. CDLQI (The Children's Dermatology Life Quality Index)

    change of the CDLQI

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

  2. POEM (Patient-Oriented Eczema Measure)

    change of the POEM

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

  3. CSMS (Combined Symptom and Medication Score)

    change of the CSMS

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

  4. VAS (Visual Analog Scale)

    change of the VAS

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

  5. ACT (Asthma Control Test)

    change of the ACT

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

  6. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start25 Nov 2021 (estimated)
  3. Primary completion25 Jul 2023 (estimated)
  4. Study completion25 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895423
Sponsor's protocol ID
04532781
Status last verified
May 2021
First submitted
17 May 2021
Last updated
20 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methotrexate therapy, Mycophenolate mofetil therapy and Cyclosporine therapy in people with Atopic Dermatitis, run by National Medical Research Center for Children's Health, Russian Federation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SCORAD (Scoring of Atopic Dermatitis) (time frame: screening (baseline), 3, 4, 6 and 12 months from the start of therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04895423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.

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