A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome
NCT ID: NCT05856526
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
43 participants
INTERVENTIONAL
2023-06-12
2025-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Spesolimab - solution for infusion
Solution for infusion
Placebo matching to spesolimab - solution for infusion
Solution for infusion
Spesolimab - solution for injection
Solution for injection
Placebo matching to spesolimab - solution for injection
Solution for injection
Spesolimab
Spesolimab - solution for infusion
Solution for infusion
Placebo matching to spesolimab - solution for infusion
Solution for infusion
Spesolimab - solution for injection
Solution for injection
Interventions
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Spesolimab - solution for infusion
Solution for infusion
Placebo matching to spesolimab - solution for infusion
Solution for infusion
Spesolimab - solution for injection
Solution for injection
Placebo matching to spesolimab - solution for injection
Solution for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of Netherton syndrome (NS) (causative SPINK5 mutations) at baseline (Visit 2).
* 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.
* Signed and dated written informed consent and assent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission in the trial
* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the clinical trial protocol (CTP) as well as in the patient, parent(s) (or patient's legal guardian) information.
Exclusion Criteria
* Patients who have used emollient on the area to be biopsied in the previous 24 hours
* Patients who have used systemic retinoids, other systemic immunosuppressants, systemic corticosteroids or phototherapy within 4 weeks prior to randomisation
* Patients who have used systemic antibiotics within 2 weeks prior to randomisation
* Patients who have received live vaccines within 4 weeks prior to randomisation
* Patients who have received investigational products, biologics or immunoglobulins within 4 weeks or 5 half-lives (whichever is longer) prior to randomisation
* 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
* Patients who have any prior exposure to BI 655130 or another interleukin 36 receptor (IL-36R) inhibitor biologics
12 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Mission Dermatology Center
Rancho Santa Margarita, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Westmead Hospital
Westmead, New South Wales, Australia
ASMC-IPSMC-skin and Veneral Diseases
Sofia, , Bulgaria
Beijing Children's Hospital, Capital Medical University
Beijing, , China
Southern Medical University Dermatology Hospital
Guangzhou, , China
The Children's Hospital Zhejiang University School Of Medicine
Hangzhou, , China
The First Affiliated Hospital, Zhejiang University
Hangzhou, , China
Dermatology Hospital, Chinese Academy of Medical Sciences
Nanjing, , China
Shanghai Skin Disease Hospital
Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiaotong University
Shanghai, , China
HOP Saint-Louis
Paris, , France
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Klinikum der Universität München AÖR
München, , Germany
Sourasky Medical Center
Tel Aviv, , Israel
Istituto Dermopatico Dell'Immacolata - IDI - IRCCS
Roma, , Italy
AO Città della Salute e Scienza
Torino, , Italy
Nagoya University Hospital
Aichi, Nagoya, , Japan
Juntendo University Urayasu Hospital
Chiba, Urayasu, , Japan
Okayama University Hospital
Okayama, Okayama, , Japan
Hospital Tunku Azizah
Kuala Lumpur, , Malaysia
Erasmus MC - Sophia Kinderziekenhuis
Rotterdam, , Netherlands
ULS de São José, E.P.E. - Hospital Sto. António Capuchos
Lisbon, , Portugal
University Children Hospital Zürich
Zurich, , Switzerland
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Countries
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Related Links
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Other Identifiers
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2022-501104-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1289-6825
Identifier Type: REGISTRY
Identifier Source: secondary_id
1368-0104
Identifier Type: -
Identifier Source: org_study_id
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