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A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Spesolimab
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Dermatology Research Associates
  • Dawes Fretzin Clinical Research Group, LLC
  • Mayo Clinic, Rochester
  • Unity Clinical Research
  • University of Pittsburgh Medical Center
  • Holdsworth House Medical Practice
  • Royal Melbourne Hospital
  • ULB Hopital Erasme
  • Dr. S. K. Siddha Medicine Professional Corporation
  • University Hospital Ostrava
  • CLI Reims Bezannes
  • HOP Edouard Herriot
  • HOP Larrey
  • Katholisches Klinikum Bochum gGmbH
  • Städtisches Klinikum Dessau
  • Universitätsklinikum Frankfurt
  • Ospedali Riuniti di Ancona
  • Azienda Ospedaliera Universitaria Pisana
  • Erasmus Medisch Centrum
  • Haukeland Universitetssykehus
  • Nordlandssykehuset HF, Bodø
  • Oslo Universitetssykehus HF, Rikshospitalet
  • Non-Public Health Care Facility LABDERM
  • Cityclinic Medical and Psychological Clinic Matusiak Partnership
  • Hospital Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Spesolimab

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent change from baseline in total abscess and inflammatory nodule count (AN) at week 12

Secondary Outcome Measures

Percent change from baseline in draining fistula count at week 12
Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12
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.
Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value at week 12
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.
Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score at week 12
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).
Achievement of Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 at week 12
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).
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
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).
Occurrence of complete elimination of draining fistulas at Week 12
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
Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at week 12
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.
Absolute change from baseline in Hidradenitis Suppurativa Quality of Life (HiS-QoL) Total score at week 12
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.
The occurrence of Treatment Emergent Adverse Events (TEAEs)

Full Information

First Posted
February 18, 2021
Last Updated
September 11, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04762277
Brief Title
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
Official Title
Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
January 19, 2022 (Actual)
Study Completion Date
April 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spesolimab
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Intervention Description
Spesolimab
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percent change from baseline in total abscess and inflammatory nodule count (AN) at week 12
Time Frame
baseline, week 12
Secondary Outcome Measure Information:
Title
Percent change from baseline in draining fistula count at week 12
Time Frame
baseline, week 12
Title
Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12
Description
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.
Time Frame
week 12
Title
Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value at week 12
Description
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.
Time Frame
baseline, week 12
Title
Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score at week 12
Description
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).
Time Frame
baseline, week 12
Title
Achievement of Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1 at week 12
Description
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).
Time Frame
week 12
Title
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
Description
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).
Time Frame
baseline, week 12
Title
Occurrence of complete elimination of draining fistulas at Week 12
Time Frame
week 12
Title
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
Time Frame
up to week 12
Title
Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at week 12
Description
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.
Time Frame
baseline, week 12
Title
Absolute change from baseline in Hidradenitis Suppurativa Quality of Life (HiS-QoL) Total score at week 12
Description
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.
Time Frame
baseline, week 12
Title
The occurrence of Treatment Emergent Adverse Events (TEAEs)
Time Frame
up to week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Facility Information:
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Mayo Clinic, Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Unity Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Holdsworth House Medical Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
ULB Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Dr. S. K. Siddha Medicine Professional Corporation
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
University Hospital Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
CLI Reims Bezannes
City
Bezannes
ZIP/Postal Code
51430
Country
France
Facility Name
HOP Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
HOP Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Katholisches Klinikum Bochum gGmbH
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Städtisches Klinikum Dessau
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
Facility Name
Nordlandssykehuset HF, Bodø
City
Bodø
ZIP/Postal Code
8005
Country
Norway
Facility Name
Oslo Universitetssykehus HF, Rikshospitalet
City
Oslo
ZIP/Postal Code
N-0372
Country
Norway
Facility Name
Non-Public Health Care Facility LABDERM
City
Ossy
ZIP/Postal Code
42624
Country
Poland
Facility Name
Cityclinic Medical and Psychological Clinic Matusiak Partnership
City
Wroclaw
ZIP/Postal Code
50-566
Country
Poland
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com/
Description
Related Info

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A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

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