A Phase 4 interventional study of Secukinumab Injection and Ustekinumab Injection in Congenital Ichthyosis, sponsored by National Medical Research Center for Children's Health, Russian Federation. Status unknown at 1 site in Russian Federation. Open to participants aged 6 Months to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-09.
Sponsored by National Medical Research Center for Children's Health, Russian Federation · Phase 4, Interventional, and Treatment
This is an experimental non-randomized clinical study aimed at expanding the indications for the use of biological drugs with the aim of using them for the pathogenetic therapy of children with congenital ichthyosis.
This is an experimental non-randomized clinical study aimed at expanding the indications for the use of biological drugs with the aim of using them for the pathogenetic therapy of children with congenital ichthyosis.
The study will include 50 children aged 6 months to 18 years with a clinically and genetically confirmed diagnosis of congenital ichthyosis. Patients will be divided into 4 groups who will receive symptomatic therapy (using active external agents, emollients and / or systemic retinoids) or biologics targeting the cytokines IL-12 / IL-23, IL-4 / IL-13 and IL -17A. Immunophenotyping of all patients will be performed, the cytokine profile and spectrum of sensitization and the degree of NF-kB activation in lymphocytes will be determined. In experimental group №3, 10 patients with Netherton syndrome will receive dupilumab, in experimental group №2, 10 patients will receive ustekinumab, and in experimental group №1 10 patients will receive secukinumab. Efficiency will be assessed using the Ichthyosis Area Severity Index (IASI), determination of the level of TEWL, and the change in quality of life will also be assessed using the Children's Dermatological Life Quality Index (CDLQI) in comparison from baseline, than at 16 and 52 weeks. Throughout the study, the safety profile (registration of the development of infectious diseases) will be assessed.
22 studies on the registry are indexed under Netherton Syndrome; 5 are open to participants now.
This study's planned enrollment of 50 is above the median of 16 across 19 interventional studies indexed under Netherton Syndrome.
Browse Netherton Syndrome studies →National Medical Research Center for Children's Health, Russian Federation is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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The subject has signed an ; parental or legal representative consent for patients under 18 years of age, as well as additional consent for patients aged ≥ 15 and \<18.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Secukinumab - subcutaneous injections into the shoulder according to the schedule of 0,1,2,3 weeks, then injections 1 time in 3 months up to 52 weeks of therapy.
Drug: Secukinumab Injection
Ustekinumab - subcutaneous injections in the shoulder on schedule 0; 1 month, then every 2 months up to 52 weeks of therapy.
Drug: Ustekinumab Injection
Dupilumab - subcutaneous injections in the shoulder: for patients weighing from 15 to \<30 kg: initial dose - 600 mg (2 injections of 300 mg), then 300 mg every 4 weeks; for patients weighing from 30 to \<60 kg: initial dose - 400 mg (2 injections of 200 mg), then 200 mg every 2 weeks; for patients weighing 60 kg or more: the initial dose is 600 mg (2 injections of 300 mg), then 300 mg every 2 weeks.
Drug: Dupilumab Injection
symptomatic therapy with emollients + systemic retinoids
Other: Symptomatic therapy
Pathogenetic therapy with biologic drugs
Pathogenetic therapy with biologic drugs
Pathogenetic therapy with biologic drugs
Active external agents, Emollients, systemic retinoids if needed
Change in Ichthyosis Area Severity Index (IASI)
Clinical measures included the Ichthyosis Area Severity Index (IASI), which integrates erythema (IASI-E) and scaling (IASI-S)
Time frame: From Baseline up to 16 weeks
Change in Ichthyosis Area Severity Index (IASI)
Clinical measures included the Ichthyosis Area Severity Index (IASI), which integrates erythema (IASI-E) and scaling (IASI-S)
Time frame: 52 weeks
Transepidermal water loss (TEWL) level change
Change in transepidermal water loss (TEWL) while rebuilding the epidermal barrier of the skin (an indicator of the effectiveness of the therapy). Measured in g/hm2.
Time frame: From Baseline up to 16 weeks
Transepidermal water loss (TEWL) level change
Change in transepidermal water loss (TEWL) while rebuilding the epidermal barrier of the skin (an indicator of the effectiveness of the therapy). Measured in g/hm2.
Time frame: 52 weeks
Change in the Children's Dermatology Life Quality Index (CDLQI)
increasing The Children's Dermatology Life Quality Index, as an indicator of the effectiveness of therapy. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The CDLQI can also be expressed as a percentage of the maximum possible score of 30.
Time frame: From Baseline up to 16 weeks
Change in the Children's Dermatology Life Quality Index (CDLQI)
Change in the Children's Dermatology Life Quality Index (CDLQI), as an indicator of the effectiveness of therapy. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The CDLQI can also be expressed as a percentage of the maximum possible score of 30.
Time frame: 52 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Mar 2023, 24 months after the start.
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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Secukinumab · Ustekinumab · Dupilumab
National Medical Research Center for Children's Health, Russian Federation