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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04876391




Registration number
NCT04876391
Ethics application status
Date submitted
4/05/2021
Date registered
6/05/2021

Titles & IDs
Public title
A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
Scientific title
An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)
Secondary ID [1] 0 0
2020-005587-55
Secondary ID [2] 0 0
1368-0067
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Spesolimab

Experimental: Participants from parent trial (1368-0052) who were on placebo or active medication -


Treatment: Drugs: Spesolimab
Spesolimab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including residual effect period (REP)
Timepoint [1] 0 0
up to week 120
Secondary outcome [1] 0 0
Percentage change in total abscess and inflammatory nodule (AN) count from baseline up to week 12
Timepoint [1] 0 0
up to week 12
Secondary outcome [2] 0 0
Percentage change in total draining fistula (DF) count from baseline up to week 12
Timepoint [2] 0 0
up to week 12
Secondary outcome [3] 0 0
Hidradenitis Suppurativa Clinical Response (HiSCR)
Timepoint [3] 0 0
up to week 12
Secondary outcome [4] 0 0
Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value up to week 12
Timepoint [4] 0 0
up to week 12
Secondary outcome [5] 0 0
Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1
Timepoint [5] 0 0
up to week 12
Secondary outcome [6] 0 0
Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score up to week 12
Timepoint [6] 0 0
up to week 12
Secondary outcome [7] 0 0
Occurrence of at least one flare (defined as at least 25 % increase in AN count with a minimum increase of 2 relative to baseline) up to week 12
Timepoint [7] 0 0
up to week 12
Secondary outcome [8] 0 0
Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain up to week 12
Timepoint [8] 0 0
up to week 12

Eligibility
Key inclusion criteria
* Patients who have completed treatment in the parent Hidradenitis suppurativa (HS) spesolimab trial (1368-0052) without premature discontinuation
* Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Woman 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 patient information and consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial
* Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
* Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
* Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial
* History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
* Major surgery (major according to the investigator's assessment) planned during this extension trial (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator
* Any condition which in the opinion of the investigator affects the safety of the patient, the patient's ability to participate in this trial or could compromise the quality of data Further exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2024
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Oklahoma
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Czechia
State/province [6] 0 0
Ostrava
Country [7] 0 0
France
State/province [7] 0 0
Bezannes
Country [8] 0 0
France
State/province [8] 0 0
Lyon
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
Germany
State/province [10] 0 0
Bochum
Country [11] 0 0
Germany
State/province [11] 0 0
Dessau
Country [12] 0 0
Germany
State/province [12] 0 0
Frankfurt am Main
Country [13] 0 0
Italy
State/province [13] 0 0
Ancona
Country [14] 0 0
Italy
State/province [14] 0 0
Pisa
Country [15] 0 0
Netherlands
State/province [15] 0 0
Rotterdam
Country [16] 0 0
Norway
State/province [16] 0 0
Bodø
Country [17] 0 0
Poland
State/province [17] 0 0
Ossy
Country [18] 0 0
Poland
State/province [18] 0 0
Wroclaw
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04876391