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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
Date last updated
9/10/2024

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
Assessment method [1] 0 0
Percent change from baseline in total abscess and inflammatory nodule count at Week 12= \[(Total Abscess at Week 12 + Total Inflammatory Nodule at Week 12) - (Total Abscess at baseline + Total Inflammatory Nodule at baseline)\] \*100/ (Total Abscess at baseline + Total Inflammatory Nodule at baseline). Percent change from baseline in total abscess and inflammatory nodule count at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12). The Least Squares Mean (Standard Error) at Week 12 is reported.
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
Assessment method [1] 0 0
Percent change from baseline in draining fistula at Week 12 was calculated as: \[(total draining fistula at Week 12) - (total draining fistula at baseline)\] \* 100 %/ (total draining fistula at baseline). Percent change from baseline in draining fistula count at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12). The Least Squares Mean (Standard Error) at Week 12 is reported.
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
Assessment method [2] 0 0
HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. Proportion of patients with achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 is reported. Proportion of patients with achievement of HiSCR at Week 12 was calculated as: number of patients with achievement of HiSCR at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places.
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
Assessment method [3] 0 0
The IHS4 assesses the hidradenitis suppurativa (HS) severity and the resulting IHS4 score is arrived at by= number of nodules \* 1 + number of abscesses \* 2 + number of draining fistula \* 4. A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Absolute change from baseline in IHS4 value at Week 12 was modelled using mixed effects model for repeated measures (MMRM) accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 2, 4, 6, 8, 10, and 12). The Least Squares Mean (Standard Error) at Week 12 is reported.
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
Assessment method [4] 0 0
HASI includes four domains to assess the severity of HS disease activity, which are erythema, induration, open ulcer and draining fistula and scored on a Likert scale 0 (none) to 3 (severe/extensive) for each predetermined body region. For body surface area (BSA) assessment, the number of palms (one palm indicates 1% of the patient's BSA) involved for each body region (head, right axilla, left axilla, anterior chest, back, anterior bathing trunk, posterior bathing trunk, other) is assessed and converted to a percentage of that region. An area score was assigned to each region using the approach (0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, 6 = 90- 100%). Scores for the four domains of HS are summed and adjusted for the area affected, and the score of each area are summed to calculate the total HASI score, which ranges from 0 (no disease) to 72 (severe disease). The Least Squares Mean (Standard Error (SE)) derive from MMRM.
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
Assessment method [5] 0 0
HS-PGA documents the physician's assessment of the patient's HS at a given timepoint. The HS-PGA score ranges from 0 to 5, where: 0=clear - no abscesses, draining fistula, inflammatory nodules or noninflammatory nodules); 1=minimal - no abscesses, draining fistula or inflammatory nodules and the presence of noninflammatory nodules); 2=mild - no abscesses or draining fistula and 1-4 inflammatory nodules, or 1 abscess or draining tunnel and no inflammatory nodules); 3=moderate - no abscesses or draining fistula and =5 inflammatory nodules, or 1 abscess or draining fistula and =1 inflammatory nodule, or 2-5 abscesses or draining fistula and \<10 inflammatory nodules); 4=severe - 2-5 abscesses or draining fistula and =10 inflammatory nodules); 5=very severe - \>5 abscesses or draining fistula). Proportion of patients with achievement of HS-PGA score of 0 or 1 at Week 12 was calculated as: number of patients with achievement of HS-PGA score of 0 or 1 at Week 12/number of patients analyzed.
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
Assessment method [6] 0 0
The HS Pain Numerical Rating Scale (NRS) is an endpoint for the assessment of HS-related pain severity. Recall period is 24 hours and response is given by an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). For the analysis of pain, weekly average of daily assessment was calculated for each visit based on values prior to the visit. Missing daily values within a week were ignored if there are at least 4 reported values. Proportion of patients with achievement of at least 30% reduction from baseline in NRS30 in Patient's Global Assessment of HS Pain at Week 12. Proportion of patients with achievement of at least 30% reduction from baseline in NRS30 in Patient's Global Assessment of HS Pain at Week 12 was calculated as: number of patients with achievement of at least 30% reduction from baseline in NRS30 in Patient's Global Assessment of HS Pain at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places.
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
Assessment method [7] 0 0
Proportion of patients with occurrence of complete elimination of draining fistulas at Week 12 is reported. Proportion of patients with occurrence of complete elimination of draining fistulas at Week 12 was calculated as: number of patients with occurrence of complete elimination of draining fistulas at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places.
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
Assessment method [8] 0 0
Proportion of patients with occurrence of at least one flare at Week 12. Flare was defined as at least 25 % increase in abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline. Proportion of patients with occurrence of at least one flare at Week 12 was calculated as: number of patients with occurrence of at least one flare at Week 12/number of patients analyzed. Proportions were rounded up to three decimal places.
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
Assessment method [9] 0 0
The DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Response categories include "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3). DLQI total score is calculated by summing the scores of each question resulting in a range of 0 to 30 with higher scores indicating greater health-related quality of life impairment. Absolute change from baseline in DLQI score at Week 12 was modelled using MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 4, 8, and 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
Assessment method [10] 0 0
HiS-QoL is a patient-administered, 17-item instrument to measure HS-specific quality of life in clinical trials with a 7-day recall period. 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 health-related quality of life. Absolute change from baseline in HiS-QoL total score at Week 12 was modelled using MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to tumor necrosis factor inhibitor (TNFi)-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit (Weeks 1, 4, 8, and 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)
Assessment method [11] 0 0
Percentage of patients with occurrence of Treatment Emergent Adverse Events (TEAEs) is reported. Percentage of patients with occurrence of Treatment Emergent Adverse Events (TEAEs) was calculated as: number of patients with occurrence of TEAEs / number of patients analyzed. Percentages were rounded to one decimal place. Time Frame: From first drug administration until 16 weeks after last drug administration, up to 28 weeks for patients who did not to roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)). From first drug administration until Week 12 for patients who did roll-over to the open-label extension (OLE) trial (trial number 1368-0067 (NCT04876391)).
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

Data sharing statement


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