Back to resultsA Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD EXT)
Primary Purpose
Hidradenitis Suppurativa
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Bimekizumab, UCB4940, HS, Hidradenitis Suppurativa, Acne inversa
Eligibility Criteria
Inclusion Criteria:
- Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study
- Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance during the open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP)
Exclusion Criteria:
- Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP)
- Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator.
- Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
- Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment
- Study participant plans to participate in another study of a medicinal product or device under investigation during this study
Sites / Locations
- Hs0005 50140
- Hs0005 50175
- Hs0005 50162
- Hs0005 50161
- Hs0005 50220
- Hs0005 50196
- Hs0005 50199
- Hs0005 50205
- Hs0005 50152
- Hs0005 50184
- Hs0005 50141
- Hs0005 50193
- Hs0005 50280
- Hs0005 50234
- Hs0005 50425
- Hs0005 50198
- Hs0005 50146
- Hs0005 50178
- Hs0005 50105
- Hs0005 50194
- Hs0005 50208
- Hs0005 50159
- Hs0005 50137
- Hs0005 50200
- Hs0005 50237
- Hs0005 50235
- Hs0005 50151
- Hs0005 50211
- Hs0005 50179
- Hs0005 50177
- Hs0005 50145
- Hs0005 50138
- Hs0005 50202
- Hs0005 50204
- Hs0005 50147
- Hs0005 50008
- Hs0005 50180
- Hs0005 50084
- Hs0005 50236
- Hs0005 50142
- Hs0005 50201
- Hs0005 50148
- Hs0005 50270
- Hs0005 30015
- Hs0005 30016
- Hs0005 30011
- Hs0005 30017
- Hs0005 30018
- Hs0005 30014
- Hs0005 30009
- Hs0005 30012
- Hs0005 40002
- Hs0005 40121
- Hs0005 40313
- Hs0005 40284
- Hs0005 40311
- Hs0005 40314
- Hs0005 40315
- Hs0005 40353
- Hs0005 50233
- Hs0005 50172
- Hs0005 50135
- Hs0005 50174
- Hs0005 50190
- Hs0005 50192
- Hs0005 50133
- Hs0005 50134
- Hs0005 50136
- Hs0005 40194
- Hs0005 40063
- Hs0005 40197
- Hs0005 40245
- Hs0005 40321
- Hs0005 40320
- Hs0005 40355
- Hs0005 40247
- Hs0005 40130
- Hs0005 40132
- Hs0005 40404
- Hs0005 40318
- Hs0005 40246
- Hs0005 40403
- Hs0005 40285
- Hs0005 40286
- Hs0005 40325
- Hs0005 40326
- Hs0005 40248
- Hs0005 40327
- Hs0005 40288
- Hs0005 40324
- Hs0005 40356
- Hs0005 40287
- Hs0005 40142
- Hs0005 40328
- Hs0005 40249
- Hs0005 40250
- Hs0005 40174
- Hs0005 40323
- Hs0005 40177
- Hs0005 40251
- Hs0005 40252
- Hs0005 40254
- Hs0005 40344
- Hs0005 40261
- Hs0005 40263
- Hs0005 40258
- Hs0005 40330
- Hs0005 20196
- Hs0005 20144
- Hs0005 20043
- Hs0005 20195
- Hs0005 20170
- Hs0005 20190
- Hs0005 20033
- Hs0005 20152
- Hs0005 20178
- Hs0005 20153
- Hs0005 20037
- Hs0005 20154
- Hs0005 20171
- Hs0005 40351
- Hs0005 40292
- Hs0005 40264
- Hs0005 40347
- Hs0005 40293
- Hs0005 40335
- Hs0005 40095
- Hs0005 40333
- Hs0005 40334
- Hs0005 40266
- Hs0005 40159
- Hs0005 40267
- Hs0005 40298
- Hs0005 40294
- Hs0005 40268
- Hs0005 40297
- Hs0005 40295
- Hs0005 40049
- Hs0005 40230
- Hs0005 40406
- Hs0005 40270
- Hs0005 40273
- Hs0005 40272
- Hs0005 40271
- Hs0005 40339
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bimekizumab dosing regimen 1
Bimekizumab dosing regimen 2
Arm Description
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.
Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.
Outcomes
Primary Outcome Measures
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Secondary Outcome Measures
Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
Results in death
Is life-threatening
Requires inpatient hospitalization or prolongation of existing hospitalization
Results in persistent disability/incapacity
Is a congenital anomaly/birth defect
Important medical events
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported.
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
HiSCR50 is defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count.
Results will be presented individually per week listed under time points.
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
HiSCR75 is defined as at least a 75 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count.
Results will be presented individually per week listed under time points.
Percentage of participants with Flare
Flare is defined as a ≥25 % increase in abscess and inflammatory nodule (AN) count with an absolute increase in AN count of ≥2 relative to Baseline.
Results will be presented individually per week listed under time points.
Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
The 4 items on the HSSQ assess the study participant's perception of the core symptoms of HS experienced in the past 7 days - pain, smell or odor, drainage or oozing from HS lesions, and itch on an 11-point numeric rating scale with higher scores indicating higher symptom level.
Results will be presented individually per week listed under time points.
Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
The DLQI is a skin disease specific questionnaire aimed at the evaluation of how the disease affects participants health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QOL.
Results will be presented individually per week listed under time points.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04901195
Brief Title
A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Acronym
BE HEARD EXT
Official Title
A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
July 28, 2026 (Anticipated)
Study Completion Date
July 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Bimekizumab, UCB4940, HS, Hidradenitis Suppurativa, Acne inversa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
658 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekizumab dosing regimen 1
Arm Type
Experimental
Arm Description
Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.
Arm Title
Bimekizumab dosing regimen 2
Arm Type
Experimental
Arm Description
Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
UCB4940
Intervention Description
Subjects will receive bimekizumab at pre-specified time-points.
Primary Outcome Measure Information:
Title
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Time Frame
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Secondary Outcome Measure Information:
Title
Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study
Description
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
Results in death
Is life-threatening
Requires inpatient hospitalization or prolongation of existing hospitalization
Results in persistent disability/incapacity
Is a congenital anomaly/birth defect
Important medical events
Time Frame
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Title
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported.
Time Frame
From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
Title
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Description
HiSCR50 is defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count.
Results will be presented individually per week listed under time points.
Time Frame
Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Title
Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Description
HiSCR75 is defined as at least a 75 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count.
Results will be presented individually per week listed under time points.
Time Frame
Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Title
Percentage of participants with Flare
Description
Flare is defined as a ≥25 % increase in abscess and inflammatory nodule (AN) count with an absolute increase in AN count of ≥2 relative to Baseline.
Results will be presented individually per week listed under time points.
Time Frame
Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Title
Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
Description
The 4 items on the HSSQ assess the study participant's perception of the core symptoms of HS experienced in the past 7 days - pain, smell or odor, drainage or oozing from HS lesions, and itch on an 11-point numeric rating scale with higher scores indicating higher symptom level.
Results will be presented individually per week listed under time points.
Time Frame
Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
Title
Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
Description
The DLQI is a skin disease specific questionnaire aimed at the evaluation of how the disease affects participants health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QOL.
Results will be presented individually per week listed under time points.
Time Frame
Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study
Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to follow the contraceptive guidance during the open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP)
Exclusion Criteria:
Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP)
Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator.
Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment
Study participant plans to participate in another study of a medicinal product or device under investigation during this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Study Director
Facility Information:
Facility Name
Hs0005 50140
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Hs0005 50175
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Hs0005 50162
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Hs0005 50161
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Hs0005 50220
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Hs0005 50196
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Facility Name
Hs0005 50199
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Hs0005 50205
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162-4708
Country
United States
Facility Name
Hs0005 50152
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Hs0005 50184
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Hs0005 50141
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Hs0005 50193
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Hs0005 50280
City
Watkinsville
State/Province
Georgia
ZIP/Postal Code
30677
Country
United States
Facility Name
Hs0005 50234
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Hs0005 50425
City
Murray
State/Province
Kentucky
ZIP/Postal Code
42071
Country
United States
Facility Name
Hs0005 50198
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Hs0005 50146
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Hs0005 50178
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Hs0005 50105
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hs0005 50194
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Hs0005 50208
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Hs0005 50159
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Hs0005 50137
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Hs0005 50200
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Hs0005 50237
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Hs0005 50235
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Hs0005 50151
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
Hs0005 50211
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Hs0005 50179
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Hs0005 50177
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Hs0005 50145
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hs0005 50138
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Hs0005 50202
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Hs0005 50204
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Facility Name
Hs0005 50147
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hs0005 50008
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Hs0005 50180
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Hs0005 50084
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Hs0005 50236
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Hs0005 50142
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Hs0005 50201
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Hs0005 50148
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Hs0005 50270
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Hs0005 30015
City
Campbelltown
Country
Australia
Facility Name
Hs0005 30016
City
Carlton
Country
Australia
Facility Name
Hs0005 30011
City
East Melbourne
Country
Australia
Facility Name
Hs0005 30017
City
Kogarah
Country
Australia
Facility Name
Hs0005 30018
City
Parkville
Country
Australia
Facility Name
Hs0005 30014
City
St Leonards
Country
Australia
Facility Name
Hs0005 30009
City
Westmead
Country
Australia
Facility Name
Hs0005 30012
City
Woolloongabba
Country
Australia
Facility Name
Hs0005 40002
City
Leuven
Country
Belgium
Facility Name
Hs0005 40121
City
Woluwe-saint-lambert
Country
Belgium
Facility Name
Hs0005 40313
City
Pleven
Country
Bulgaria
Facility Name
Hs0005 40284
City
Sofia
Country
Bulgaria
Facility Name
Hs0005 40311
City
Sofia
Country
Bulgaria
Facility Name
Hs0005 40314
City
Sofia
Country
Bulgaria
Facility Name
Hs0005 40315
City
Sofia
Country
Bulgaria
Facility Name
Hs0005 40353
City
Stara Zagora
Country
Bulgaria
Facility Name
Hs0005 50233
City
Barrie
Country
Canada
Facility Name
Hs0005 50172
City
Cobourg
Country
Canada
Facility Name
Hs0005 50135
City
Edmonton
Country
Canada
Facility Name
Hs0005 50174
City
London
Country
Canada
Facility Name
Hs0005 50190
City
Richmond Hill
Country
Canada
Facility Name
Hs0005 50192
City
Saskatoon
Country
Canada
Facility Name
Hs0005 50133
City
Surrey
Country
Canada
Facility Name
Hs0005 50134
City
Waterloo
Country
Canada
Facility Name
Hs0005 50136
City
Winnipeg
Country
Canada
Facility Name
Hs0005 40194
City
Praha 10
Country
Czechia
Facility Name
Hs0005 40063
City
Praha 5
Country
Czechia
Facility Name
Hs0005 40197
City
Amiens Cedex
Country
France
Facility Name
Hs0005 40245
City
Antony
Country
France
Facility Name
Hs0005 40321
City
Auxerre
Country
France
Facility Name
Hs0005 40320
City
La Rochelle
Country
France
Facility Name
Hs0005 40355
City
Le Mans
Country
France
Facility Name
Hs0005 40247
City
Lyon
Country
France
Facility Name
Hs0005 40130
City
Marseille
Country
France
Facility Name
Hs0005 40132
City
Nice
Country
France
Facility Name
Hs0005 40404
City
Reims
Country
France
Facility Name
Hs0005 40318
City
Rouen Cedex
Country
France
Facility Name
Hs0005 40246
City
Saint Mandé
Country
France
Facility Name
Hs0005 40403
City
Saint-etienne
Country
France
Facility Name
Hs0005 40285
City
Toulon
Country
France
Facility Name
Hs0005 40286
City
Toulouse
Country
France
Facility Name
Hs0005 40325
City
Berlin
Country
Germany
Facility Name
Hs0005 40326
City
Berlin
Country
Germany
Facility Name
Hs0005 40248
City
Bochum
Country
Germany
Facility Name
Hs0005 40327
City
Bonn
Country
Germany
Facility Name
Hs0005 40288
City
Darmstadt
Country
Germany
Facility Name
Hs0005 40324
City
Dresden
Country
Germany
Facility Name
Hs0005 40356
City
Dresden
Country
Germany
Facility Name
Hs0005 40287
City
Frankfurt/main
Country
Germany
Facility Name
Hs0005 40142
City
Hamburg
Country
Germany
Facility Name
Hs0005 40328
City
Hannover
Country
Germany
Facility Name
Hs0005 40249
City
Kiel
Country
Germany
Facility Name
Hs0005 40250
City
Lübeck
Country
Germany
Facility Name
Hs0005 40174
City
Mainz
Country
Germany
Facility Name
Hs0005 40323
City
München
Country
Germany
Facility Name
Hs0005 40177
City
Münster
Country
Germany
Facility Name
Hs0005 40251
City
Athens
Country
Greece
Facility Name
Hs0005 40252
City
Thessaloniki
Country
Greece
Facility Name
Hs0005 40254
City
Debrecen
Country
Hungary
Facility Name
Hs0005 40344
City
Dublin
Country
Ireland
Facility Name
Hs0005 40261
City
Catania
Country
Italy
Facility Name
Hs0005 40263
City
Roma
Country
Italy
Facility Name
Hs0005 40258
City
Rozzano
Country
Italy
Facility Name
Hs0005 40330
City
Torino
Country
Italy
Facility Name
Hs0005 20196
City
Bunkyo-ku
Country
Japan
Facility Name
Hs0005 20144
City
Fukuoka
Country
Japan
Facility Name
Hs0005 20043
City
Itabashi-ku
Country
Japan
Facility Name
Hs0005 20195
City
Kagoshima
Country
Japan
Facility Name
Hs0005 20170
City
Kurume
Country
Japan
Facility Name
Hs0005 20190
City
Kyoto
Country
Japan
Facility Name
Hs0005 20033
City
Nagoya
Country
Japan
Facility Name
Hs0005 20152
City
Nakagami-gun
Country
Japan
Facility Name
Hs0005 20178
City
Nishinomiya
Country
Japan
Facility Name
Hs0005 20153
City
Obihiro
Country
Japan
Facility Name
Hs0005 20037
City
Osaka
Country
Japan
Facility Name
Hs0005 20154
City
Sapporo
Country
Japan
Facility Name
Hs0005 20171
City
Sendai
Country
Japan
Facility Name
Hs0005 40351
City
Breda
Country
Netherlands
Facility Name
Hs0005 40292
City
Groningen
Country
Netherlands
Facility Name
Hs0005 40264
City
Rotterdam
Country
Netherlands
Facility Name
Hs0005 40347
City
Lodz
Country
Poland
Facility Name
Hs0005 40293
City
Rzeszow
Country
Poland
Facility Name
Hs0005 40335
City
Warszawa
Country
Poland
Facility Name
Hs0005 40095
City
Wroclaw
Country
Poland
Facility Name
Hs0005 40333
City
Wroclaw
Country
Poland
Facility Name
Hs0005 40334
City
Wroclaw
Country
Poland
Facility Name
Hs0005 40266
City
Badalona
Country
Spain
Facility Name
Hs0005 40159
City
Barcelona
Country
Spain
Facility Name
Hs0005 40267
City
Barcelona
Country
Spain
Facility Name
Hs0005 40298
City
Granada
Country
Spain
Facility Name
Hs0005 40294
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Hs0005 40268
City
Madrid
Country
Spain
Facility Name
Hs0005 40297
City
Manises
Country
Spain
Facility Name
Hs0005 40295
City
Pontevedra
Country
Spain
Facility Name
Hs0005 40049
City
Sevilla
Country
Spain
Facility Name
Hs0005 40230
City
Valencia
Country
Spain
Facility Name
Hs0005 40406
City
Genève
Country
Switzerland
Facility Name
Hs0005 40270
City
Antalya
Country
Turkey
Facility Name
Hs0005 40273
City
Gaziantep
Country
Turkey
Facility Name
Hs0005 40272
City
Istanbul
Country
Turkey
Facility Name
Hs0005 40271
City
İ̇zmir
Country
Turkey
Facility Name
Hs0005 40339
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
https://www.Vivli.org
Learn more about this trial
A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
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