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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04762277




Registration number
NCT04762277
Ethics application status
Date submitted
18/02/2021
Date registered
21/02/2021

Titles & IDs
Public title
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
Scientific title
Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa
Secondary ID [1] 0 0
2020-003672-40
Secondary ID [2] 0 0
1368-0052
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 - solution for infusion
Treatment: Drugs - Placebo matching spesolimab - solution for infusion
Treatment: Drugs - Spesolimab- solution for injection
Treatment: Drugs - Placebo matching to spesolimab- solution for injection

Experimental: Spesolimab -

Placebo comparator: Placebo -


Treatment: Drugs: Spesolimab - solution for infusion
Solution for infusion

Treatment: Drugs: Placebo matching spesolimab - solution for infusion
Solution for infusion

Treatment: Drugs: Spesolimab- solution for injection
Solution for injection

Treatment: Drugs: Placebo matching to spesolimab- solution for injection
Solution for injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Total Abscess and Inflammatory Nodule Count at Week 12
Timepoint [1] 0 0
MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change from baseline to Week 12 is reported.
Secondary outcome [1] 0 0
Percent Change From Baseline in Draining Fistula Count at Week 12
Timepoint [1] 0 0
MMRM included measurements from baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of percent change in draining fistula from baseline to Week 12 is reported.
Secondary outcome [2] 0 0
Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Timepoint [2] 0 0
At baseline (Week 0) and at Week 12.
Secondary outcome [3] 0 0
Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 12
Timepoint [3] 0 0
MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change in IHS4 from baseline to Week 12 is reported.
Secondary outcome [4] 0 0
Absolute Change From Baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) Score at Week 12
Timepoint [4] 0 0
MMRM included measurements at baseline (Week 0) and at Weeks 1, 2, 4, 6, 8, 10, and 12 after first drug administration. MMRM estimates of absolute change from baseline in HASI score at Week 12 is reported in the table below.
Secondary outcome [5] 0 0
Achievement of Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) Score of 0 or 1 at Week 12
Timepoint [5] 0 0
At Week 12.
Secondary outcome [6] 0 0
Achievement of at Least 30% Reduction From Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain at Week 12
Timepoint [6] 0 0
At baseline (Week 0) and at Week 12.
Secondary outcome [7] 0 0
Occurrence of Complete Elimination of Draining Fistulas at Week 12
Timepoint [7] 0 0
Baseline (Week 0) and at Week 12.
Secondary outcome [8] 0 0
Occurrence of at Least One Flare at Week 12
Timepoint [8] 0 0
At Week 12.
Secondary outcome [9] 0 0
Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
Timepoint [9] 0 0
MMRM included measurements at baseline (Week 0) and at Weeks 1, 4, 8, and 12 after first drug administration. MMRM estimates of absolute change in DLQI from baseline to Week 12 is reported.
Secondary outcome [10] 0 0
Absolute Change From Baseline in Hidradenitis Suppurativa Quality of Life (HiS-QoL) Total Score at Week 12
Timepoint [10] 0 0
MMRM included measurements at baseline (Week 0) and at Weeks 1, 4, 8, and 12 after first drug administration. MMRM estimates of absolute change in HiS-QoL from baseline to Week 12 is reported.
Secondary outcome [11] 0 0
The Occurrence of Treatment Emergent Adverse Events (TEAEs)
Timepoint [11] 0 0
Up to 12 weeks for patients who did roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)) and up to 28 weeks who did not roll-over to the OLE trial. For details please see description.

Eligibility
Key inclusion criteria
* Male or female adult patients, 18 years of age or older
* Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures
* Moderate to severe Hidradenitis suppurativa (HS), based on International Hidradenitis Suppurativa Severity Score System (IHS4) criteria, for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history. (If IHS4 scoring is not available, equivalent scoring based on scoring systems as HS-PGA or Hurley are acceptable based on documented investigator assessment)
* HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, perineal)
* Biologic naive or TNF inhibitor (TNFi)-failure for HS
* Inadequate response to an adequate course of appropriate oral antibiotics for treatment of HS in the last 1 year, as per investigator discretion. This is not applicable for TNFi-failure patients
* Total abscess and inflammatory nodule (AN) count of greater than or equal to 5
* Total draining fistula count of less than or equal to 20 Further inclusion criteria apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Presence of active skin lesions other than HS that interfere with the assessment of HS
* Use of restricted medications as below:

* Topical corticosteroids over HS lesions within 1 week of Visit 2
* Systemic antibiotics within 4 weeks of visit 2
* Systemic non-biologic immunomodulatory and/or immunosuppressive agents use for HS within 4 weeks (or 5 half lives, whichever is longer) of visit 2
* Biologic agents use within 12 weeks or 5 half-lives, whichever is longer, prior to visit 2
* Opioid analgesics within 2 weeks of visit 2
* Live virus vaccine within 6 weeks of visit 2
* Prior exposure to any immunosuppressive biologic other than TNFi for HS
* Prior exposure to Interleukin 36 Receptor (IL-36R) inhibitors including spesolimab
* Treatment with any investigational device or investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to visit 2
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating
* History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
* Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening) or who have ever received stem cell therapy (e.g., Remestemcel-L) Further exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
6/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/04/2022
Sample size
Target
Accrual to date
Final
52
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
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Czechia
State/province [8] 0 0
Ostrava
Country [9] 0 0
France
State/province [9] 0 0
Bezannes
Country [10] 0 0
France
State/province [10] 0 0
Lyon
Country [11] 0 0
France
State/province [11] 0 0
Toulouse
Country [12] 0 0
Germany
State/province [12] 0 0
Bochum
Country [13] 0 0
Germany
State/province [13] 0 0
Dessau
Country [14] 0 0
Germany
State/province [14] 0 0
Frankfurt am Main
Country [15] 0 0
Italy
State/province [15] 0 0
Ancona
Country [16] 0 0
Italy
State/province [16] 0 0
Pisa
Country [17] 0 0
Netherlands
State/province [17] 0 0
Rotterdam
Country [18] 0 0
Norway
State/province [18] 0 0
Bergen
Country [19] 0 0
Norway
State/province [19] 0 0
Bodø
Country [20] 0 0
Norway
State/province [20] 0 0
Oslo
Country [21] 0 0
Poland
State/province [21] 0 0
Ossy
Country [22] 0 0
Poland
State/province [22] 0 0
Wroclaw
Country [23] 0 0
Spain
State/province [23] 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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04762277