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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04762277




Registration number
NCT04762277
Ethics application status
Date submitted
18/02/2021
Date registered
21/02/2021
Date last updated
13/09/2023

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
Treatment: Drugs - Placebo

Experimental: Spesolimab -

Placebo Comparator: Placebo -


Treatment: Drugs: Spesolimab
Spesolimab

Treatment: Drugs: Placebo
Placebo
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 (AN) at week 12
Timepoint [1] 0 0
baseline, week 12
Secondary outcome [1] 0 0
Percent change from baseline in draining fistula count at week 12
Timepoint [1] 0 0
baseline, week 12
Secondary outcome [2] 0 0
Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12
Timepoint [2] 0 0
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
baseline, week 12
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
baseline, week 12
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
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 Hidradenitis suppurativa (HS) Pain at week 12
Timepoint [6] 0 0
baseline, week 12
Secondary outcome [7] 0 0
Occurrence of complete elimination of draining fistulas at Week 12
Timepoint [7] 0 0
week 12
Secondary outcome [8] 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 [8] 0 0
up to 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
baseline, week 12
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
baseline, week 12
Secondary outcome [11] 0 0
The occurrence of Treatment Emergent Adverse Events (TEAEs)
Timepoint [11] 0 0
up to week 16

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
This study is open to adults with a chronic inflammatory skin disease called hidradenitis
suppurativa. The purpose of this study is to find out whether a medicine called spesolimab
helps people with moderate to severe hidradenitis suppurativa.

Participants are put into 2 groups by chance. One group takes spesolimab. The other group
takes placebo. Every participant has twice the chance of being in the spesolimab group than
in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every
week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under
the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and
injections but do not contain any medicine.

Participants are treated in the study for about 3 months. During this time, they visit the
study site about 9 times. After completing this part of the study, participants are offered
to join another clinical study in which all participants get spesolimab. Participants who
cannot join the other study, stay in this study for about 4 more months. During this time,
participants do not take spesolimab nor placebo but they visit the study site 2 times to have
their health checked.

At study visits, doctors thoroughly check the skin of participants to count lumps (nodules)
and boils (abscesses). The results between the spesolimab group and the placebo group are
compared after 3 months of treatment. The doctors also regularly check the general health of
the participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04762277
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