NCT07151508

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 19, 2025

Last Update Submit

September 4, 2025

Conditions

Neterton Syndrome

Keywords

Neterton syndrometargeted treatmentsecukinumabdupilumabichtiosisatopyIL-17IL-4/13

Outcome Measures

Primary Outcomes (1)

  • overal survival Kaplan-Mayer method

    Evaluation of the efficacy and safety of dupilumab and secukinumab therapy in patients with Netherton syndrome

    3 and 6 months from the start of each type of therapy

Secondary Outcomes (1)

  • event free survival

    3 and 6 months from the start of each type of therapy

Interventions

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.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients with Neterton syndrome

You may qualify if:

  • Pediatric patients with Neterton syndrome
  • Treatment with secukinumab and/or dupilumab for at least 3 months

You may not qualify if:

  • Irregular administration of therapy
  • Development of a serious adverse event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology

Moscow, Russia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2025

First Posted

September 3, 2025

Study Start

December 19, 2023

Primary Completion

December 25, 2024

Study Completion

January 10, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Locations

RU(1)