Back to resultsA Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (DETERMINED 1)
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Risankizumab
Placebo for risankizumab
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, Risankizumab, Placebo
Eligibility Criteria
Inclusion Criteria:
- Participant with moderate to severe HS for at least 1 year prior to baseline visit.
- HS lesions present in at least two distinct anatomical areas.
- Draining fistula count of ≤ 20 at Baseline visit.
- Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.
- Participants are required to use a daily antiseptic wash on their HS lesions.
- Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.
Exclusion Criteria:
- Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
- Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.
- Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.
- Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit.
- Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.
- Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.
Sites / Locations
- Burke Pharmaceutical Research /ID# 211671
- Bakersfield Derma & Skin Cance /ID# 211684
- Wallace Medical Group /ID# 215958
- Integrative Skin Science and Research /ID# 212550
- UC Davis Health /ID# 211436
- California Dermatology Institute /ID# 211786
- CCD Research, PLLC /ID# 214479
- Advanced Medical Research /ID# 215203
- Arlington Dermatology /ID# 219096
- Tufts Medical Center /ID# 212680
- Beth Israel Deaconess Medical Center /ID# 211794
- Hamzavi Dermatology /ID# 212318
- University of Minnesota /ID# 212319
- Minnesota Clinical Study Center /ID# 211979
- Skin Specialists, PC /ID# 211675
- Montefiore Medical Center - Moses Campus /ID# 211800
- Oregon Medical Res Center PC /ID# 211796
- Penn State Hershey Medical Ctr /ID# 211659
- Rhode Island Hospital /ID# 211807
- Modern Research Associates, PL /ID# 215202
- Virginia Clinical Research, Inc. /ID# 215959
- Premier Clinical Research /ID# 211799
- Woden Dermatology /ID# 212437
- Westmead Hospital /ID# 212438
- Veracity Clinical Research /ID# 212432
- Skin Health Institute Inc /ID# 212433
- Sinclair Dermatology /ID# 215548
- The Royal Melbourne Hospital /ID# 212436
- Fremantle Dermatology /ID# 212434
- Wiseman Dermatology Research /ID# 212243
- Dr. Irina Turchin PC Inc. /ID# 212248
- Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043
- K. Papp Clinical Research /ID# 212166
- Dre Angelique Gagne-Henley M.D. inc. /ID# 212249
- Chu de Nice-Hopital L'Archet Ii /Id# 212563
- Hopital Prive d'Antony /ID# 212566
- CHU de SAINT ETIENNE - Hopital Nord /ID# 212564
- HCL - Hopital Edouard Herriot /ID# 218408
- Polyclinique Courlancy /ID# 212567
- CHU Toulouse - Hopital Larrey /ID# 213581
- Universitaetsklinikum Frankfurt /ID# 211913
- Klinikum Ruhr Univ Bochum /ID# 211910
- Staedtisches Klinikum Dessau /ID# 211914
- Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912
- Nagoya City University Hospital /ID# 211155
- Fukuoka University Hospital /ID# 211303
- Tohoku University Hospital /ID# 212214
- University of the Ryukyus Hospital /ID# 211373
- Toranomon Hospital /ID# 211742
- Bravis Ziekenhuis /ID# 212536
- Erasmus Medisch Centrum /ID# 212535
- Amphia Ziekenhuis /ID# 212538
- Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015
- Hospital de Manises /ID# 211541
- Hospital General Universitario Alicante /ID# 212010
- Hospital Santa Creu i Sant Pau /ID# 212009
- Hospital Universitario Virgen de las Nieves /ID# 212014
- Hospital General Universitario Gregorio Maranon /ID# 212011
- Hospital Universitario Virgen de la Victoria /ID# 212013
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Arm Label
Risankizumab 180 mg
Risankizumab 360 mg
Placebo
Risankizumab 180 mg / Risankizumab 360 mg
Risankizumab 360 mg / Risankizumab 360 mg
Placebo / Risankizumab 360 mg
Arm Description
In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.
Secondary Outcome Measures
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3
NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3
NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.
Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.
Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16
HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16
HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16
HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03926169
Brief Title
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Acronym
DETERMINED 1
Official Title
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
August 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
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
Yes
5. Study Description
Brief Summary
The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis Suppurativa, Risankizumab, Placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
243 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risankizumab 180 mg
Arm Type
Experimental
Arm Description
In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Arm Title
Risankizumab 360 mg
Arm Type
Experimental
Arm Description
In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Arm Title
Risankizumab 180 mg / Risankizumab 360 mg
Arm Type
Experimental
Arm Description
In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
Arm Title
Risankizumab 360 mg / Risankizumab 360 mg
Arm Type
Experimental
Arm Description
In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
Arm Title
Placebo / Risankizumab 360 mg
Arm Type
Placebo Comparator
Arm Description
In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
ABBV-066, SKYRIZI
Intervention Description
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
Intervention Type
Drug
Intervention Name(s)
Placebo for risankizumab
Intervention Description
Placebo for risankizumab is administered as a SC injection in PFS
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
Description
HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.
Time Frame
Baseline (Week 0), Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3
Description
NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.
Time Frame
Baseline (Week 0) to Week 8
Title
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3
Description
NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.
Time Frame
Baseline (Week 0) to Week 16
Title
Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline
Time Frame
Baseline (Week 0) to Week 16
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Description
The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.
Time Frame
Baseline (Week 0) to Week 16
Title
Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16
Description
HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Time Frame
Baseline (Week 0) to Week 16
Title
Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16
Description
HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Time Frame
Baseline (Week 0) to Week 16
Title
Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16
Description
HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Time Frame
Baseline (Week 0) to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant with moderate to severe HS for at least 1 year prior to baseline visit.
HS lesions present in at least two distinct anatomical areas.
Draining fistula count of ≤ 20 at Baseline visit.
Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.
Participants are required to use a daily antiseptic wash on their HS lesions.
Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.
Exclusion Criteria:
Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.
Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.
Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit.
Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.
Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Burke Pharmaceutical Research /ID# 211671
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913-6404
Country
United States
Facility Name
Bakersfield Derma & Skin Cance /ID# 211684
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Wallace Medical Group /ID# 215958
City
Los Angeles
State/Province
California
ZIP/Postal Code
90056
Country
United States
Facility Name
Integrative Skin Science and Research /ID# 212550
City
Sacramento
State/Province
California
ZIP/Postal Code
95815-4500
Country
United States
Facility Name
UC Davis Health /ID# 211436
City
Sacramento
State/Province
California
ZIP/Postal Code
95816-3300
Country
United States
Facility Name
California Dermatology Institute /ID# 211786
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320-2130
Country
United States
Facility Name
CCD Research, PLLC /ID# 214479
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416-1745
Country
United States
Facility Name
Advanced Medical Research /ID# 215203
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328-6141
Country
United States
Facility Name
Arlington Dermatology /ID# 219096
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Tufts Medical Center /ID# 212680
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 211794
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Hamzavi Dermatology /ID# 212318
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
University of Minnesota /ID# 212319
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0356
Country
United States
Facility Name
Minnesota Clinical Study Center /ID# 211979
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Skin Specialists, PC /ID# 211675
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Montefiore Medical Center - Moses Campus /ID# 211800
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Oregon Medical Res Center PC /ID# 211796
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Penn State Hershey Medical Ctr /ID# 211659
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Facility Name
Rhode Island Hospital /ID# 211807
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Modern Research Associates, PL /ID# 215202
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Virginia Clinical Research, Inc. /ID# 215959
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Premier Clinical Research /ID# 211799
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Woden Dermatology /ID# 212437
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Westmead Hospital /ID# 212438
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Veracity Clinical Research /ID# 212432
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Skin Health Institute Inc /ID# 212433
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Sinclair Dermatology /ID# 215548
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
The Royal Melbourne Hospital /ID# 212436
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Fremantle Dermatology /ID# 212434
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Wiseman Dermatology Research /ID# 212243
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Dr. Irina Turchin PC Inc. /ID# 212248
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
K. Papp Clinical Research /ID# 212166
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Dre Angelique Gagne-Henley M.D. inc. /ID# 212249
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
Chu de Nice-Hopital L'Archet Ii /Id# 212563
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
Hopital Prive d'Antony /ID# 212566
City
Antony
State/Province
Ile-de-France
ZIP/Postal Code
92160
Country
France
Facility Name
CHU de SAINT ETIENNE - Hopital Nord /ID# 212564
City
St. Priest En Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Facility Name
HCL - Hopital Edouard Herriot /ID# 218408
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Polyclinique Courlancy /ID# 212567
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU Toulouse - Hopital Larrey /ID# 213581
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Universitaetsklinikum Frankfurt /ID# 211913
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinikum Ruhr Univ Bochum /ID# 211910
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Staedtisches Klinikum Dessau /ID# 211914
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Nagoya City University Hospital /ID# 211155
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Fukuoka University Hospital /ID# 211303
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Tohoku University Hospital /ID# 212214
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
University of the Ryukyus Hospital /ID# 211373
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Toranomon Hospital /ID# 211742
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Bravis Ziekenhuis /ID# 212536
City
Bergen op Zoom
State/Province
Noord-Brabant
ZIP/Postal Code
4624 VT
Country
Netherlands
Facility Name
Erasmus Medisch Centrum /ID# 212535
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Amphia Ziekenhuis /ID# 212538
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital de Manises /ID# 211541
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Hospital General Universitario Alicante /ID# 212010
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 212009
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves /ID# 212014
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 212011
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria /ID# 212013
City
Malaga
ZIP/Postal Code
29010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Links:
URL
https://www.rxabbvie.com
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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