- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03478787
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
June 21, 2021 updated by: AbbVie
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
327
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada, G1V 4X7
- Dermatologique du Quebec /ID# 203050
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Alberta
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Calgary, Alberta, Canada, T3E 0B2
- Beacon Dermatology Inc /ID# 203054
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British Columbia
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Surrey, British Columbia, Canada, V3V 0C6
- Enverus Medical Research /ID# 203043
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New Brunswick
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Fredericton, New Brunswick, Canada, E3B 1G9
- Dr. Irina Turchin PC Inc. /ID# 203052
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1Z2
- Eastern Canada Cutaneous Resea /ID# 203045
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Ontario
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Hamilton, Ontario, Canada, L8N 1Y2
- Dermatrials Research /ID# 203051
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Quebec
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Saint-Jerome, Quebec, Canada, J7Z 7E2
- Dre Angelique Gagne-Henley M.D. inc. /ID# 203053
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Nice, France, 06202
- Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591
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Paris, France, 75010
- Hopital Saint-Louis /ID# 203586
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Reims, France, 51100
- Polyclinique Courlancy /ID# 203588
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Toulouse, France, 31059
- Hopital Larrey - CHU de Toulouse /ID# 203587
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Seine-Maritime
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Rouen CEDEX, Seine-Maritime, France, 76031
- Charles Nicolle CHU Rouen /ID# 203590
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Munich, Germany, 80802
- TU Uniklinik Munchen /ID# 203919
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Lazio
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Roma, Lazio, Italy, 00168
- Policlinico A. Gemelli /ID# 203009
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Lombardia
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Milan, Lombardia, Italy, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6525 GA
- Radboud Universitair Medisch Centrum /ID# 202560
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Noord-Brabant
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Bergen op Zoom, Noord-Brabant, Netherlands, 4624 VT
- Bravis Ziekenhuis /ID# 205232
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1105 AZ
- Academisch Medical center Amsterdam /ID# 202556
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Lodzkie
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Lodz, Lodzkie, Poland, 90-265
- Dermed Centrum Medyczne Sp. z o.o /ID# 203171
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Malopolskie
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Krakow, Malopolskie, Poland, 31-302
- Klinika Dermatologii Pod Fortem /ID# 204180
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Mazowieckie
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Warsaw, Mazowieckie, Poland, 01-817
- Przychodnia Specjalistyczna High-Med /ID# 203183
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Warsaw, Mazowieckie, Poland, 02-758
- Klinika Ambroziak Sp. z o.o. /ID# 203928
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Podkarpackie
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Rzeszow, Podkarpackie, Poland, 35-055
- KSW nr1 w Rzeszowie /ID# 203776
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Podlaskie
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Białystok, Podlaskie, Poland, 15-351
- Osteo-Medic S.C. /ID# 203742
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Alicante, Spain, 03010
- Hospital General Universitario Alicante /ID# 203764
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Granada, Spain, 18016
- Hospital Universitario Clinico San Cecilio /ID# 203760
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Madrid, Spain, 28006
- Hospital Universitario de la Princesa /ID# 203754
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre /ID# 203756
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Valencia, Spain, 46015
- Hospital Universitario Arnau Vilanova /ID# 203763
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Valencia
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Manises, Valencia, Spain, 46940
- Hospital de Manises /ID# 203757
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Salford, United Kingdom, M6 8HD
- The University of Manchester /ID# 204720
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London, City Of
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London, London, City Of, United Kingdom, E11 1NR
- Whipps Cross Univ Hospital /ID# 204723
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London, London, City Of, United Kingdom, SE1 9RT
- Guy's and St Thomas' NHS Found /ID# 204721
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Arizona
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Glendale, Arizona, United States, 85308
- Advanced Research Associates - Glendale /ID# 204335
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Phoenix, Arizona, United States, 85032
- Alliance Dermatology and MOHs /ID# 204336
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California
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Bakersfield, California, United States, 93309
- Bakersfield Derma & Skin Cance /ID# 202115
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Fremont, California, United States, 94538
- Center for Dermatology Clin Res /ID# 202116
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Los Angeles, California, United States, 90045
- Dermatology Res. Assoc., CA /ID# 202170
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Sacramento, California, United States, 95816
- UC Davis Health /ID# 202263
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San Diego, California, United States, 92103
- Medderm Associates /ID# 202162
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Connecticut
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Farmington, Connecticut, United States, 06032
- UConn Health Main /ID# 201745
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Florida
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North Miami Beach, Florida, United States, 33162-4708
- Tory P Sullivan, MD PA /ID# 202177
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Ocala, Florida, United States, 34470
- Renstar Medical Research /ID# 202113
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Port Orange, Florida, United States, 32127
- Progressive Medical Research /ID# 202183
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West Palm Beach, Florida, United States, 33406-6063
- Integrated Clinical Research LLC /ID# 202152
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Kentucky
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Louisville, Kentucky, United States, 40241
- Dermatology Specialists Resear /ID# 202145
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Maryland
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Rockville, Maryland, United States, 20850
- Dermatology and Skin Cancer Specialists, LLC /ID# 203938
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Massachusetts
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Andover, Massachusetts, United States, 01810
- ORA, Inc. /ID# 204342
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Boston, Massachusetts, United States, 02215-5400
- Beth Israel Deaconess Medical Center /ID# 204340
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Minnesota
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New Brighton, Minnesota, United States, 55112
- Minnesota Clinical Study Center /ID# 202369
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Missouri
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Saint Louis, Missouri, United States, 63117
- Central Dermatology, PC /ID# 202156
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New Jersey
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East Windsor, New Jersey, United States, 08520
- Psoriasis Treatment Ctr of Central NJ /ID# 202107
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Ohio
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Cincinnati, Ohio, United States, 45236
- Synexus Research Cincinnati /ID# 202161
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Oregon
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Portland, Oregon, United States, 97210
- Oregon Derm & Res. Ctr /ID# 201652
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Portland, Oregon, United States, 97223
- Oregon Medical Res Center PC /ID# 201651
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Rhode Island
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Johnston, Rhode Island, United States, 02919
- Clinical Partners, LLC /ID# 201736
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Texas
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Houston, Texas, United States, 77004-8097
- Center for Clinical Studies - Houston (Binz) /ID# 202178
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San Antonio, Texas, United States, 78229
- Progressive Clinical Research /ID# 202155
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Webster, Texas, United States, 77598
- Center for Clinical Studies - Webster TX /ID# 202154
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Utah
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Salt Lake City, Utah, United States, 84112-5500
- University of Utah /ID# 204035
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert Mem Lutheran Hosp /ID# 204896
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Risankizumab
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).
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Subcutaneous (SC) injection
Other Names:
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ACTIVE_COMPARATOR: Secukinumab
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.
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Subcutaneous (SC) injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
Time Frame: Week 16
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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.
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Week 16
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Percentage of Participants With a PASI 90 at Week 52
Time Frame: Week 52
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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.
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Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52
Time Frame: Week 52
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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.
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Week 52
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Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52
Time Frame: Week 52
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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.
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Week 52
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Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52
Time Frame: Week 52
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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.
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Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 8, 2018
Primary Completion (ACTUAL)
July 8, 2020
Study Completion (ACTUAL)
July 8, 2020
Study Registration Dates
First Submitted
March 23, 2018
First Submitted That Met QC Criteria
March 23, 2018
First Posted (ACTUAL)
March 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 13, 2021
Last Update Submitted That Met QC Criteria
June 21, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M16-766
- 2017-004932-12 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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 Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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