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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05856526
Other study ID # 1368-0104
Secondary ID 2022-501104-10-0
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 15, 2023
Est. completion date January 3, 2028

Study information

Verified date June 2024
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 and 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 about 1 year. During this time, they visit the study site 16 times. Where possible, 4 of 16 visits can be done at the participant's home instead of the study site. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 39
Est. completion date January 3, 2028
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Male or female patients, aged 12 years and older (weight minimum is 35kg). - 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 topical corticosteroids (medium to high, US class I-V), topical retinoids, topical calcineurin inhibitors or keratolytics within 1 week prior to randomisation - 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 - Further exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Australia Westmead Hospital Westmead New South Wales
Belgium UZ Leuven Leuven
Bulgaria ASMC-IPSMC-skin and Veneral Diseases Sofia
China 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
Finland Suomen Terveystalo oy Tampere Tampere
France HOP Saint-Louis Paris
Germany Universitätsklinikum Erlangen Erlangen
Germany Universitätsklinikum Heidelberg Heidelberg
Germany Universitätsklinikum Schleswig-Holstein, Campus Kiel Kiel
Germany Klinikum der Universität München AÖR München
Israel Sourasky Medical Center Tel Aviv
Italy Istituto Dermopatico Dell'Immacolata - IDI - IRCCS Roma
Italy AO Città della Salute e Scienza Torino
Japan Nagoya University Hospital Aichi, Nagoya
Japan Juntendo University Urayasu Hospital Chiba, Urayasu
Japan Okayama University Hospital Okayama, Okayama
Malaysia Hospital Tunku Azizah Kuala Lumpur
Malaysia Sunway Medical Centre Selangor Darul Ehsan
Netherlands Erasmus MC - Sophia Kinderziekenhuis Rotterdam
Portugal ULS de São José, E.P.E. - Hospital Sto. António Capuchos Lisboa
Switzerland University Children Hospital Zürich Zürich
United Kingdom Queen Elizabeth University Hospital Glasgow
United States Yale University School of Medicine New Haven Connecticut
United States Virginia Clinical Research, Inc. Norfolk Virginia
United States Mission Dermatology Center Rancho Santa Margarita California

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  China,  Finland,  France,  Germany,  Israel,  Italy,  Japan,  Malaysia,  Netherlands,  Portugal,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary IASI response Ichthyosis Area Severity Index (IASI) response is defined as a decrease of at least 50 % absolute change in IASI score from baseline at Week 16. At baseline and at Week 16.
Secondary Key secondary endpoint: IGA response Investigator Global Assessment (IGA) at Week 16.
Secondary IGA response Investigator Global Assessment (IGA) up to Week 12.
Secondary IASI response Ichthyosis Area Severity Index (IASI) At baseline and up to Week 12.
Secondary IASI-E subscore response Ichthyosis Area Severity Index - Erythema (IASI-E) At baseline and up to Week 16.
Secondary IASI-S subscore response Ichthyosis Area Severity Index - Scaling (IASI-S) At baseline and up to Week 16
Secondary Percent change from baseline in IASI score Ichthyosis Area Severity Index (IASI) At baseline and up to Week 16.
Secondary Absolute change from baseline in NRS pain The Numeric Pain Rating Scale (NRS) At baseline and up to Week 16.
Secondary Absolute change from baseline in NRS itch The Numeric Rating Scale (NRS) At baseline and up to Week 16.
Secondary Absolute change from baseline in DLQI/CDLQI score Dermatology Life Quality Index (DLQI)/Children Dermatology Life Quality Index (CDLQI) At baseline and up to Week 16.
Secondary The occurrence of treatment emergent adverse events including serious and/or opportunistic infections up to 172 weeks.
See also
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Completed NCT05583669 - A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects Phase 1
Completed NCT01428297 - A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome Phase 1
Recruiting NCT05789056 - Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome Phase 2/Phase 3
Recruiting NCT05521438 - Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome Phase 2/Phase 3
Completed NCT05388903 - A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects Phase 1
Recruiting NCT06137157 - Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome Phase 1
Not yet recruiting NCT05902663 - Natural History of Netherton Syndrome
Recruiting NCT04244006 - A Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton Syndrome Phase 2/Phase 3
Recruiting NCT03417856 - Defining the Skin and Blood Biomarkers of Ichthyosis
Completed NCT02113904 - Clinical Trial Using Humira in Netherton Syndrome Phase 2
Recruiting NCT05211830 - A Study to Evaluate Topically Applied SXR1096 Cream in Patients With Netherton Syndrome Phase 1/Phase 2
Completed NCT03041038 - The Efficacy and Safety of Secukinumab in Patients With Ichthyoses Phase 2
Recruiting NCT02081313 - Natural History and Biological Study of Netherton Syndrome N/A
Recruiting NCT01545323 - Gene Therapy for Netherton Syndrome Phase 1

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