Neterton SyndromeNCT07151508
Successful Treatment of Netherton Syndrome With Combination of Secukinumab and Dupilumab
An observational study of Neterton Syndrome, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
Trial summary
In this study, we describe our experience with secukinumab (IL-17A inhibitor) and dupilumab (IL-4/IL-13 inhibitor) treatment of a group of pediatric patients with severe Neterton syndrome. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neterton Syndrome
- What is being tested?
- Secukinumab was administered in a weight-adapted dosing regimen ? Dupilumab was administered at a dose dependent on the patient's weight and age
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteRussia
- Study dates
- 19 Dec 2023to 10 Jan 2025
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients with Neterton syndrome
Who may be able to join
- Pediatric patients with Neterton syndrome
- Treatment with secukinumab and/or dupilumab for at least 3 months
Who cannot join
- Irregular administration of therapy
- Development of a serious adverse event
Trial locations and contacts
1 site in 1 country.
Russia1 site
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Moscow
About this study
Official title: Successful Treatment of Netherton Syndrome With Combination of Secukinumab and Dupilumab.
In this study, we describe our experience with secukinumab (IL-17A inhibitor) and dupilumab (IL-4/IL-13 inhibitor) treatment of a group of pediatric patients with severe Neterton syndrome.
Read the detailed description
Pediatric patients qualified for participation in the study if they had a documented diagnosis of Neterton syndrome and they received treatment with sekukinumab or dupilumab for at least 3 months.
All patients received treatment in the Department of Immunology at the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology from January 2021 to June 2024.
A total of 15 patients from 13 families with NS were enrolled in the study. The median age of the patients was 8 years (1;15), and the male/female ratio 9/6.
In this study, 14 patients initially received secukinumab therapy, for 12/14 patients dupilumab was added, and 2 patients continued secukinumab monotherapy. The median time to switch from secukinumab monotherapy to combination therapy was 4 months (3;27). One patient initially received dupilumab monotherapy and was switched to combination therapy (Fig. 1). Treatment duration for each type of treatment was at least 3 months at the time of this report.
Secukinumab was administered in a weight-adapted dosing regimen equivalent to that used in clinical trials for psoriasis: 75 mg for less than 25 kg,150 mg for 25 to 50 kg, and 300 mg for greater than 50 kg at baseline and weeks1,2,3, and 4 and monthly there after.
Dupilumab was administered at a dose dependent on the patient's weight and age in accordance with the instructions.
The patients were evaluated before and 3-6 months after treatment initiation of secukinumab/dupilumab and combination therapy, including laboratory monitoring of complete blood cell count, liver enzyme levels, kidney function tests and IL17A levels in CD4 lymphocytes. Treatment response was assessed by the following criteria: ISS total score, IgE level and and IL17A levels in CD4 lymphocytes.
Additionally, standardized photographs were taken by a medical photographer. The ISS total score was assessed on these photographs.
All adverse events (AEs) during therapy were recorded. The investigator provided guidance to the patient or caregiver on how to identify and document AEs.
- Conditions
- Neterton Syndrome
- Being tested
- Secukinumab was administered in a weight-adapted dosing regimen ? Dupilumab was administered at a dose dependent on the patient's weight and age
- Keywords
- Neterton syndrome, targeted treatment, secukinumab, dupilumab, ichtiosis, atopy, IL-17, IL-4/13
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab was administered in a weight-adapted dosing regimen ? Dupilumab was administered at a dose dependent on the patient's weight and ageDevice
Secukinumab was administered in a weight-adapted dosing regimen equivalent to that used in clinical trials for psoriasis: 75 mg for less than 25 kg,150 mg for 25 to 50 kg, and 300 mg for greater than 50 kg at baseline and weeks1,2,3, and 4 and monthly there after.
Dupilumab was administered at a dose dependent on the patient's weight and age in accordance with the instructions.
What is being measured
The primary outcome is the main question the study is designed to answer.
overal survival Kaplan-Mayer method
Evaluation of the efficacy and safety of dupilumab and secukinumab therapy in patients with Netherton syndrome
Measured: 3 and 6 months from the start of each type of therapy
Secondary outcomes (1)
event free survival
Evaluation of the efficacy and safety of dupilumab and secukinumab therapy in patients with Netherton syndrome
Measured: 3 and 6 months from the start of each type of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start19 Dec 2023
- Primary completion25 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neterton SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151508
- Sponsor's protocol ID
- NCHPOI-2025--07
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successful Treatment of Netherton Syndrome With Combination of Secukinumab and Dupilumab.
- ClinicalTrials.gov ID
- NCT07151508
- Acronym / sponsor ID
- NCHPOI-2025--07
- Conditions
- Neterton Syndrome
- Keywords
- Neterton syndrome, targeted treatment, secukinumab, dupilumab, ichtiosis, atopy, IL-17, IL-4/13
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we describe our experience with secukinumab (IL-17A inhibitor) and dupilumab (IL-4/IL-13 inhibitor) treatment of a group of pediatric patients with severe Neterton syndrome.
Detailed description
Pediatric patients qualified for participation in the study if they had a documented diagnosis of Neterton syndrome and they received treatment with sekukinumab or dupilumab for at least 3 months.
All patients received treatment in the Department of Immunology at the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology from January 2021 to June 2024.
A total of 15 patients from 13 families with NS were enrolled in the study. The median age of the patients was 8 years (1;15), and the male/female ratio 9/6.
In this study, 14 patients initially received secukinumab therapy, for 12/14 patients dupilumab was added, and 2 patients continued secukinumab monotherapy. The median time to switch from secukinumab monotherapy to combination therapy was 4 months (3;27). One patient initially received dupilumab monotherapy and was switched to combination therapy (Fig. 1). Treatment duration for each type of treatment was at least 3 months at the time of this report.
Secukinumab was administered in a weight-adapted dosing regimen equivalent to that used in clinical trials for psoriasis: 75 mg for less than 25 kg,150 mg for 25 to 50 kg, and 300 mg for greater than 50 kg at baseline and weeks1,2,3, and 4 and monthly there after.
Dupilumab was administered at a dose dependent on the patient's weight and age in accordance with the instructions.
The patients were evaluated before and 3-6 months after treatment initiation of secukinumab/dupilumab and combination therapy, including laboratory monitoring of complete blood cell count, liver enzyme levels, kidney function tests and IL17A levels in CD4 lymphocytes. Treatment response was assessed by the following criteria: ISS total score, IgE level and and IL17A levels in CD4 lymphocytes.
Additionally, standardized photographs were taken by a medical photographer. The ISS total score was assessed on these photographs.
All adverse events (AEs) during therapy were recorded. The investigator provided guidance to the patient or caregiver on how to identify and document AEs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with Neterton syndrome
Key inclusion criteria (2 listed)
- Pediatric patients with Neterton syndrome
- Treatment with secukinumab and/or dupilumab for at least 3 months
Key exclusion criteria (2 listed)
- Irregular administration of therapy
- Development of a serious adverse event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secukinumab was administered in a weight-adapted dosing regimen ? Dupilumab was administered at a dose dependent on the patient's weight and ageSecukinumab was administered in a weight-adapted dosing regimen equivalent to that used in clinical trials for psoriasis: 75 mg for less than 25 kg,150 mg for 25 to 50 kg, and 300 mg for greater than 50 kg at baseline and weeks1,2,3, and 4 and monthly there after. Dupilumab was administered at a dose dependent on the patient's weight and age in accordance with the instructions. | Device | – |
Primary outcome
overal survival Kaplan-Mayer method
Time frame: 3 and 6 months from the start of each type of therapy
Evaluation of the efficacy and safety of dupilumab and secukinumab therapy in patients with Netherton syndrome
1 secondary outcome
event free survival
Time frame: 3 and 6 months from the start of each type of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neterton Syndrome, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 5 Sep 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overal survival Kaplan-Mayer method (time frame: 3 and 6 months from the start of each type of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.