Back to resultsA Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
Primary Purpose
Hidradenitis Suppurativa
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Spesolimab
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria:
- Patients who have completed treatment in the parent Hidradenitis suppurativa (HS) spesolimab trial (1368-0052) without premature discontinuation
- Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and consent form.
Exclusion Criteria:
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial
- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
- Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial
- History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
- Major surgery (major according to the investigator's assessment) planned during this extension trial (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator
- Any condition which in the opinion of the investigator affects the safety of the patient, the patient's ability to participate in this trial or could compromise the quality of data Further exclusion criteria apply
Sites / Locations
- Dermatology Research Associates
- Dawes Fretzin Clinical Research Group, LLC
- Mayo Clinic, Rochester
- Unity Clinical Research
- Holdsworth House Medical Practice
- Royal Melbourne Hospital
- 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
- Nordlandssykehuset HF, Bodø
- 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 Type
Experimental
Arm Label
Participants from parent trial (1368-0052) who were on placebo or active medication
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including residual effect period (REP)
Secondary Outcome Measures
Percentage change in total abscess and inflammatory nodule (AN) count from baseline up to week 12
Percentage change in total draining fistula (DF) count from baseline up to week 12
Hidradenitis Suppurativa Clinical Response (HiSCR)
HiSCR is defined as at least a 50% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase in the abscess or draining fistula count.
Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value up to 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.
Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1
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).
Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score up to 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).
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
Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain up to week 12
The Pain NRS assesses the HS-related pain severity. The Pain NRS is completed by the patients during clinic visits. Response is given by an 11-point scale ranging from 0 (no HS pain) to 10 (HS pain as bad as one can imagine).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04876391
Brief Title
A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
Official Title
An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
April 29, 2024 (Anticipated)
Study Completion Date
April 29, 2024 (Anticipated)
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 hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study.
The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems 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
Single Group Assignment
Masking
None (Open Label)
Masking Description
All medication kit assignments will occur in an open label fashion except for medications provided for visit 1. Only administration of study medication at visit 1 is blinded.
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants from parent trial (1368-0052) who were on placebo or active medication
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Spesolimab
Intervention Description
Spesolimab
Primary Outcome Measure Information:
Title
Occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including residual effect period (REP)
Time Frame
up to week 120
Secondary Outcome Measure Information:
Title
Percentage change in total abscess and inflammatory nodule (AN) count from baseline up to week 12
Time Frame
up to week 12
Title
Percentage change in total draining fistula (DF) count from baseline up to week 12
Time Frame
up to week 12
Title
Hidradenitis Suppurativa Clinical Response (HiSCR)
Description
HiSCR is defined as at least a 50% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase in the abscess or draining fistula count.
Time Frame
up to week 12
Title
Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) value up to 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
up to week 12
Title
Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score of 0 or 1
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
up to week 12
Title
Absolute change from baseline in Hidradenitis Suppurativa Area and Severity Index (HASI) score up to 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
up to 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
Achievement of at least 30% reduction from baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of HS Pain up to week 12
Description
The Pain NRS assesses the HS-related pain severity. The Pain NRS is completed by the patients during clinic visits. 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
up to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have completed treatment in the parent Hidradenitis suppurativa (HS) spesolimab trial (1368-0052) without premature discontinuation
Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and consent form.
Exclusion Criteria:
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial
Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
Use of any restricted medication or any drug considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the 1368-0052 parent trial
History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
Major surgery (major according to the investigator's assessment) planned during this extension trial (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator
Any condition which in the opinion of the investigator affects the safety of the patient, the patient's ability to participate in this trial or could compromise the quality of data 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
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
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
69437
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
Nordlandssykehuset HF, Bodø
City
Bodø
ZIP/Postal Code
N-8092
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
http://www.mystudywindow.com
Description
Related Info
Learn more about this trial
A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
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