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NCT05856526 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT05856526: Clinical Trial Phase 2 study, sponsored by Boehringer Ingelheim.
NCT05856526 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05856526, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study 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.
Primary Outcome
Proportion of participants with an Ichthyosis Area Severity Index (IASI) response at Week 16 is reported. IASI response was defined as a decrease of at least 50% absolute change in IASI score from baseline at Week 16. Proportions were rounded to 3 decimal places. IASI is a composite score based on the global Congenital Ichthyosis Severity Instrument (CISI) score that captures differences in severity in different body regions as a function of their body surface area, and also standardizes the nu
Interventions
- DRUG Spesolimab - solution for infusion
- DRUG Placebo matching to spesolimab - solution for infusion
- DRUG Spesolimab - solution for injection
- DRUG Placebo matching to spesolimab - solution for injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2023-06-12 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 2 |
Why NCT05856526 stopped before completion
NCT05856526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 4 interventions - of which Spesolimab - solution for infusion is the first listed.
NCT05856526 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05856526 about?
NCT05856526 is a clinical study titled "A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome". 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 grou...
What is the current status of trial NCT05856526?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2023-06-12. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT05856526?
The interventions under investigation include: Spesolimab - solution for infusion (DRUG), Placebo matching to spesolimab - solution for infusion (DRUG), Spesolimab - solution for injection (DRUG), Placebo matching to spesolimab - solution for injection (DRUG).
Who is sponsoring clinical trial NCT05856526?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05856526's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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