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Monoclonal Antibodies

Spesolimab for Netherton Syndrome

Phase 2 & 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least moderate severity of erythema at baseline (visit 2) (Ichthyosis Area Severity Index (IASI) score ≥ 16 and IASI-Erythema (E) score ≥8) and ≥ 3 on Investigator Global Assessment (IGA) score
Confirmed diagnosis of Netherton syndrome (NS) (causative SPINK5 mutations) at baseline (Visit 2)
Must not have
Patients who have any prior exposure to BI 655130 or another interleukin 36 receptor (IL-36R) inhibitor biologics
Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 16.

Summary

This trial is to see if a medicine called spesolimab helps people with Netherton Syndrome. Participants receive an injection every month for one year & doctors regularly check symptoms & health.

Who is the study for?
This trial is for individuals aged 12 and older with Netherton syndrome, a skin condition. Participants must have moderate to severe symptoms, be willing to use effective birth control if applicable, and weigh at least 35kg. They cannot have used certain medications or treatments recently or received live vaccines within the last month.
What is being tested?
The study tests spesolimab's effectiveness in treating Netherton syndrome compared to a placebo. Initially given as an infusion, then monthly injections under the skin, participants are randomly assigned to either treatment with a higher chance of receiving spesolimab.
What are the potential side effects?
While specific side effects aren't listed here, participants' general health will be monitored regularly for any unwanted effects of spesolimab throughout the year-long study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My skin condition is moderately severe with a high redness and overall severity score.
Select...
I have been diagnosed with Netherton syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have never used BI 655130 or any IL-36R inhibitor treatments.
Select...
My liver tests are not severely abnormal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 16.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 16. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Absolute change from baseline in DLQI/CDLQI score
Absolute change from baseline in NRS itch
Absolute change from baseline in NRS pain
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SpesolimabExperimental Treatment3 Interventions
Group II: PlaceboPlacebo Group4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spesolimab - solution for infusion
2021
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,548 Previous Clinical Trials
14,401,265 Total Patients Enrolled
1 Trials studying Netherton Syndrome
100 Patients Enrolled for Netherton Syndrome

Media Library

Spesolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05856526 — Phase 2 & 3
Netherton Syndrome Clinical Trial 2023: Spesolimab Highlights & Side Effects. Trial Name: NCT05856526 — Phase 2 & 3
Spesolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05856526 — Phase 2 & 3
Netherton Syndrome Research Study Groups: Placebo, Spesolimab
~2 spots leftby Dec 2024
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