Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa
Query!
Secondary ID [1]
0
0
2020-003672-40
Query!
Secondary ID [2]
0
0
1368-0052
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Spesolimab
Treatment: Drugs - Placebo
Experimental: Spesolimab -
Placebo Comparator: Placebo -
Treatment: Drugs: Spesolimab
Spesolimab
Treatment: Drugs: Placebo
Placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percent change from baseline in total abscess and inflammatory nodule count (AN) at week 12
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
baseline, week 12
Query!
Secondary outcome [1]
0
0
Percent change from baseline in draining fistula count at week 12
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
baseline, week 12
Query!
Secondary outcome [2]
0
0
Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12
Query!
Assessment method [2]
0
0
HiSCR is defined as at least a 50% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to baseline.
Query!
Timepoint [2]
0
0
week 12
Query!
Secondary outcome [3]
0
0
Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value at week 12
Query!
Assessment method [3]
0
0
The IHS4 assesses the HS severity and the resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease.
Query!
Timepoint [3]
0
0
baseline, week 12
Query!
Secondary outcome [4]
0
0
Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score at week 12
Query!
Assessment method [4]
0
0
HASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (severe disease).
Query!
Timepoint [4]
0
0
baseline, week 12
Query!
Secondary outcome [5]
0
0
Achievement of Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 at week 12
Query!
Assessment method [5]
0
0
The HS-PGA score ranges from 0 to 5, where 0 (clear: no abscesses, draining tunnels, inflammatory nodules or noninflammatory nodules), 1 (minimal: no abscesses, draining tunnels or inflammatory nodules and the presence of noninflammatory nodules), 2 (mild: no abscesses or draining tunnels and 1-4 inflammatory nodules, or 1 abscess or draining tunnel and no inflammatory nodules), 3 (moderate: no abscesses or draining tunnels and =5 inflammatory nodules, or 1 abscess or draining tunnel and =1 inflammatory nodule, or 2-5 abscesses or draining tunnels and <10 inflammatory nodules), 4 (severe: 2-5 abscesses or draining tunnels and =10 inflammatory nodules), 5 (very severe: >5 abscesses or draining tunnels).
Query!
Timepoint [5]
0
0
week 12
Query!
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
Query!
Assessment method [6]
0
0
The Pain NRS assesses the HS-related pain severity. The Pain NRS will be completed on a daily diary by subjects from Screening through Week 12. Response is given by an 11-point scale ranging from 0 (no HS pain) to 10 (HS pain as bad as one can imagine).
Query!
Timepoint [6]
0
0
baseline, week 12
Query!
Secondary outcome [7]
0
0
Occurrence of complete elimination of draining fistulas at Week 12
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
week 12
Query!
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
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
up to week 12
Query!
Secondary outcome [9]
0
0
Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at week 12
Query!
Assessment method [9]
0
0
DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. It's total score is calculated by summing the scores of each question resulting in a range of 0 to 30. The higher the score, the more the quality of life is impaired.
Query!
Timepoint [9]
0
0
baseline, week 12
Query!
Secondary outcome [10]
0
0
Absolute change from baseline in Hidradenitis Suppurativa Quality of Life (HiS-QoL) Total score at week 12
Query!
Assessment method [10]
0
0
HiS-QoL is a patient-administered, 17-item instrument to measure HS-specific quality of life in clinical trials. The 17-item HiS-QoL included four symptom items, eight activity-adaptation items and five psychosocial items. The item scores are summed to create a total ranging from 0 to 68, with higher scores indicating more severe impact on quality of life.
Query!
Timepoint [10]
0
0
baseline, week 12
Query!
Secondary outcome [11]
0
0
The occurrence of Treatment Emergent Adverse Events (TEAEs)
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
up to week 16
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
6/04/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
21/04/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
52
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Holdsworth House Medical Practice - Sydney
Query!
Recruitment hospital [2]
0
0
Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2010 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Indiana
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Minnesota
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Oklahoma
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Pennsylvania
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Bruxelles
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Ontario
Query!
Country [8]
0
0
Czechia
Query!
State/province [8]
0
0
Ostrava
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
Bezannes
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Lyon
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Toulouse
Query!
Country [12]
0
0
Germany
Query!
State/province [12]
0
0
Bochum
Query!
Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Dessau
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Frankfurt am Main
Query!
Country [15]
0
0
Italy
Query!
State/province [15]
0
0
Ancona
Query!
Country [16]
0
0
Italy
Query!
State/province [16]
0
0
Pisa
Query!
Country [17]
0
0
Netherlands
Query!
State/province [17]
0
0
Rotterdam
Query!
Country [18]
0
0
Norway
Query!
State/province [18]
0
0
Bergen
Query!
Country [19]
0
0
Norway
Query!
State/province [19]
0
0
Bodø
Query!
Country [20]
0
0
Norway
Query!
State/province [20]
0
0
Oslo
Query!
Country [21]
0
0
Poland
Query!
State/province [21]
0
0
Ossy
Query!
Country [22]
0
0
Poland
Query!
State/province [22]
0
0
Wroclaw
Query!
Country [23]
0
0
Spain
Query!
State/province [23]
0
0
Barcelona
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04762277
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04762277
Download to PDF