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A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome

NCT05856526 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-03-12

Study results available
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Summary

This study is open to people with a skin disease called Netherton syndrome (NS). People can join the study if they are 12 years or older. The purpose of this study is to find out whether a medicine called spesolimab helps people with NS.

Participants are divided into a spesolimab and a placebo group. Placebo injections look like spesolimab injections but do not contain any medicine. Every participant has a 2 in 3 chance of being in the spesolimab group. In the beginning, participants get the study medicine as an injection into a vein. Afterwards, they get it as an injection under the skin every month.

After 4 months, participants in the placebo group switch to spesolimab treatment.

Participants are in the study for up to 3 years. During this time, they visit the study site up to 42 times. The doctors regularly check participants' NS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.

Conditions

Interventions

DRUG

Spesolimab - solution for infusion

Solution for infusion

DRUG

Placebo matching to spesolimab - solution for infusion

Solution for infusion

DRUG

Spesolimab - solution for injection

Solution for injection

DRUG

Placebo matching to spesolimab - solution for injection

Solution for injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2025-01-13
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • China
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Portugal
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05856526 on ClinicalTrials.gov