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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
Date last updated
14/05/2024

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
27/07/2021
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
This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study.

The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.
Trial website
https://clinicaltrials.gov/study/NCT04876391
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04876391