Back to resultsRisankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
risankizumab
secukinumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit
- Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis
- Subject must be a candidate for systemic therapy as assessed by the investigator;
- Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.
Exclusion Criteria:
- History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; or active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
- Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein derivative (PPD) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
- Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold)
- History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix
- Previous exposure to risankizumab
- Previous exposure to secukinumab
Sites / Locations
- Advanced Research Associates - Glendale /ID# 204335
- Alliance Dermatology and MOHs /ID# 204336
- Bakersfield Derma & Skin Cance /ID# 202115
- Center for Dermatology Clin Res /ID# 202116
- Dermatology Res. Assoc., CA /ID# 202170
- UC Davis Health /ID# 202263
- Medderm Associates /ID# 202162
- UConn Health Main /ID# 201745
- Tory P Sullivan, MD PA /ID# 202177
- Renstar Medical Research /ID# 202113
- Progressive Medical Research /ID# 202183
- Integrated Clinical Research LLC /ID# 202152
- Dermatology Specialists Resear /ID# 202145
- Dermatology and Skin Cancer Specialists, LLC /ID# 203938
- ORA, Inc. /ID# 204342
- Beth Israel Deaconess Medical Center /ID# 204340
- Minnesota Clinical Study Center /ID# 202369
- Central Dermatology, PC /ID# 202156
- Psoriasis Treatment Ctr of Central NJ /ID# 202107
- Synexus Research Cincinnati /ID# 202161
- Oregon Derm & Res. Ctr /ID# 201652
- Oregon Medical Res Center PC /ID# 201651
- Clinical Partners, LLC /ID# 201736
- Center for Clinical Studies - Houston (Binz) /ID# 202178
- Progressive Clinical Research /ID# 202155
- Center for Clinical Studies - Webster TX /ID# 202154
- University of Utah /ID# 204035
- Froedtert Mem Lutheran Hosp /ID# 204896
- Beacon Dermatology Inc /ID# 203054
- Enverus Medical Research /ID# 203043
- Dr. Irina Turchin PC Inc. /ID# 203052
- Eastern Canada Cutaneous Resea /ID# 203045
- Dermatrials Research /ID# 203051
- Dre Angelique Gagne-Henley M.D. inc. /ID# 203053
- Dermatologique du Quebec /ID# 203050
- Charles Nicolle CHU Rouen /ID# 203590
- Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591
- Hopital Saint-Louis /ID# 203586
- Polyclinique Courlancy /ID# 203588
- Hopital Larrey - CHU de Toulouse /ID# 203587
- TU Uniklinik Munchen /ID# 203919
- Policlinico A. Gemelli /ID# 203009
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982
- Radboud Universitair Medisch Centrum /ID# 202560
- Bravis Ziekenhuis /ID# 205232
- Academisch Medical center Amsterdam /ID# 202556
- Dermed Centrum Medyczne Sp. z o.o /ID# 203171
- Klinika Dermatologii Pod Fortem /ID# 204180
- Przychodnia Specjalistyczna High-Med /ID# 203183
- Klinika Ambroziak Sp. z o.o. /ID# 203928
- KSW nr1 w Rzeszowie /ID# 203776
- Osteo-Medic S.C. /ID# 203742
- Hospital de Manises /ID# 203757
- Hospital General Universitario Alicante /ID# 203764
- Hospital Universitario Clinico San Cecilio /ID# 203760
- Hospital Universitario de la Princesa /ID# 203754
- Hospital Universitario 12 de Octubre /ID# 203756
- Hospital Universitario Arnau Vilanova /ID# 203763
- Whipps Cross Univ Hospital /ID# 204723
- Guy's and St Thomas' NHS Found /ID# 204721
- The University of Manchester /ID# 204720
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Risankizumab
Secukinumab
Arm Description
Participants randomized to risankizumab receive 2 injections of active risankizumab (150 mg total dosage) subcutaneously (SC) at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
Participants randomized to secukinumab receive 2 injections of active secukinumab (300 mg total dosage) SC at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
Outcomes
Primary Outcome Measures
Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
Percentage of Participants With a PASI 90 at Week 52
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Secondary Outcome Measures
Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all 3; Almost clear (1) = mean > 0, < 1.5; Mild (2) = mean ≥ 1.5, < 2.5; Moderate (3) = mean ≥ 2.5, < 3.5; and Severe (4) = mean ≥ 3.5.
Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03478787
Brief Title
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
Official Title
A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
July 8, 2020 (Actual)
Study Completion Date
July 8, 2020 (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
No
5. Study Description
Brief Summary
The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
327 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risankizumab
Arm Type
Experimental
Arm Description
Participants randomized to risankizumab receive 2 injections of active risankizumab (150 mg total dosage) subcutaneously (SC) at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
Arm Title
Secukinumab
Arm Type
Active Comparator
Arm Description
Participants randomized to secukinumab receive 2 injections of active secukinumab (300 mg total dosage) SC at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
Intervention Type
Drug
Intervention Name(s)
risankizumab
Other Intervention Name(s)
ABBV-066, BI 655066, SKYRIZI
Intervention Description
Subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
secukinumab
Other Intervention Name(s)
Cosentyx
Intervention Description
Subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
Description
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
Time Frame
Week 16
Title
Percentage of Participants With a PASI 90 at Week 52
Description
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52
Description
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Time Frame
Week 52
Title
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52
Description
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all 3; Almost clear (1) = mean > 0, < 1.5; Mild (2) = mean ≥ 1.5, < 2.5; Moderate (3) = mean ≥ 2.5, < 3.5; and Severe (4) = mean ≥ 3.5.
Time Frame
Week 52
Title
Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52
Description
The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Time Frame
Week 52
10. Eligibility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit
Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis
Subject must be a candidate for systemic therapy as assessed by the investigator;
Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound.
Exclusion Criteria:
History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; or active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein derivative (PPD) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold)
History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix
Previous exposure to risankizumab
Previous exposure to secukinumab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Research Associates - Glendale /ID# 204335
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Alliance Dermatology and MOHs /ID# 204336
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Bakersfield Derma & Skin Cance /ID# 202115
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Center for Dermatology Clin Res /ID# 202116
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Dermatology Res. Assoc., CA /ID# 202170
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
UC Davis Health /ID# 202263
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Medderm Associates /ID# 202162
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UConn Health Main /ID# 201745
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Tory P Sullivan, MD PA /ID# 202177
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162-4708
Country
United States
Facility Name
Renstar Medical Research /ID# 202113
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Progressive Medical Research /ID# 202183
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Integrated Clinical Research LLC /ID# 202152
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406-6063
Country
United States
Facility Name
Dermatology Specialists Resear /ID# 202145
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Dermatology and Skin Cancer Specialists, LLC /ID# 203938
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
ORA, Inc. /ID# 204342
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 204340
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Minnesota Clinical Study Center /ID# 202369
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Central Dermatology, PC /ID# 202156
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Psoriasis Treatment Ctr of Central NJ /ID# 202107
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Synexus Research Cincinnati /ID# 202161
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Oregon Derm & Res. Ctr /ID# 201652
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Res Center PC /ID# 201651
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Clinical Partners, LLC /ID# 201736
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Center for Clinical Studies - Houston (Binz) /ID# 202178
City
Houston
State/Province
Texas
ZIP/Postal Code
77004-8097
Country
United States
Facility Name
Progressive Clinical Research /ID# 202155
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Center for Clinical Studies - Webster TX /ID# 202154
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
University of Utah /ID# 204035
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
Froedtert Mem Lutheran Hosp /ID# 204896
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Beacon Dermatology Inc /ID# 203054
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Facility Name
Enverus Medical Research /ID# 203043
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Dr. Irina Turchin PC Inc. /ID# 203052
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Eastern Canada Cutaneous Resea /ID# 203045
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Z2
Country
Canada
Facility Name
Dermatrials Research /ID# 203051
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Dre Angelique Gagne-Henley M.D. inc. /ID# 203053
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
Dermatologique du Quebec /ID# 203050
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Charles Nicolle CHU Rouen /ID# 203590
City
Rouen CEDEX
State/Province
Seine-Maritime
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Saint-Louis /ID# 203586
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Polyclinique Courlancy /ID# 203588
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Hopital Larrey - CHU de Toulouse /ID# 203587
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
TU Uniklinik Munchen /ID# 203919
City
Munich
ZIP/Postal Code
80802
Country
Germany
Facility Name
Policlinico A. Gemelli /ID# 203009
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Radboud Universitair Medisch Centrum /ID# 202560
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Bravis Ziekenhuis /ID# 205232
City
Bergen op Zoom
State/Province
Noord-Brabant
ZIP/Postal Code
4624 VT
Country
Netherlands
Facility Name
Academisch Medical center Amsterdam /ID# 202556
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Dermed Centrum Medyczne Sp. z o.o /ID# 203171
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Klinika Dermatologii Pod Fortem /ID# 204180
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-302
Country
Poland
Facility Name
Przychodnia Specjalistyczna High-Med /ID# 203183
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Klinika Ambroziak Sp. z o.o. /ID# 203928
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-758
Country
Poland
Facility Name
KSW nr1 w Rzeszowie /ID# 203776
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Osteo-Medic S.C. /ID# 203742
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Hospital de Manises /ID# 203757
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Hospital General Universitario Alicante /ID# 203764
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitario Clinico San Cecilio /ID# 203760
City
Granada
ZIP/Postal Code
18016
Country
Spain
Facility Name
Hospital Universitario de la Princesa /ID# 203754
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 203756
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Arnau Vilanova /ID# 203763
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Whipps Cross Univ Hospital /ID# 204723
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Found /ID# 204721
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
The University of Manchester /ID# 204720
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
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
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). 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
Citations:
PubMed Identifier
35050485
Citation
Crowley JJ, Langley RG, Gordon KB, Pinter A, Ferris LK, Rubant S, Photowala H, Xue Z, Wu T, Zhan T, Beeck S, Shah M, Warren RB. Efficacy of Risankizumab versus Secukinumab in Patients with Moderate-to-Severe Psoriasis: Subgroup Analysis from the IMMerge Study. Dermatol Ther (Heidelb). 2022 Feb;12(2):561-575. doi: 10.1007/s13555-021-00679-6. Epub 2022 Jan 20.
Results Reference
derived
Learn more about this trial
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
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