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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 16.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 16.
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 moreTrial 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
2,550 Previous Clinical Trials
15,769,250 Total Patients Enrolled
1 Trials studying Netherton Syndrome
100 Patients Enrolled for Netherton Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs or biologics in the last month.I have never used BI 655130 or any IL-36R inhibitor treatments.My skin condition is moderately severe with a high redness and overall severity score.I am 12 years or older and weigh at least 35kg.I have not received any live vaccines in the last 4 weeks.My liver tests are not severely abnormal.I haven't used certain skin treatments like steroids or retinoids in the last week.I haven't used systemic retinoids, immunosuppressants, corticosteroids, or phototherapy in the last 4 weeks.I have not taken antibiotics in the last 2 weeks.I have not applied any skin moisturizer on the biopsy area in the last 24 hours.I have been diagnosed with Netherton syndrome.I have signed and understand the consent form for this trial.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Spesolimab
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