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Monoclonal Antibodies

Spesolimab for Netherton Syndrome

Phase 2 & 3

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 172 weeks.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My skin condition is moderately severe with a high redness and overall severity score.

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I have been diagnosed with Netherton syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 172 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 172 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 172 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Absolute change from baseline in DLQI/CDLQI score

Absolute change from baseline in NRS itch

Absolute change from baseline in NRS pain

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SpesolimabExperimental Treatment3 Interventions

Group II: PlaceboPlacebo Group4 Interventions

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,868 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a current opportunity for individuals to join this clinical trial?

"Reportedly, this clinical trial is currently enrolling participants. The study was first posted on May 15th 2023 and has been edited since then on the 19th of that same month."

Answered by AI

To what extent is this research protocol being populated by participants?

"Affirmative. Clinicaltrials.gov registers that this medical investigation is currently accepting participants, with the original posting being on May 15th 2023 and the most recent edit occurring four days later. 39 people have to be recruited from one site for successful completion of the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05856526.