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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
327

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
      • Quebec, Canada, G1V 4X7
        • Dermatologique du Quebec /ID# 203050
    • Alberta
      • Calgary, Alberta, Canada, T3E 0B2
        • Beacon Dermatology Inc /ID# 203054
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research /ID# 203043
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Dr. Irina Turchin PC Inc. /ID# 203052
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1Z2
        • Eastern Canada Cutaneous Resea /ID# 203045
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research /ID# 203051
    • Quebec
      • Saint-Jerome, Quebec, Canada, J7Z 7E2
        • Dre Angelique Gagne-Henley M.D. inc. /ID# 203053
  • France
      • Nice, France, 06202
        • Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2 /ID# 203591
      • Paris, France, 75010
        • Hopital Saint-Louis /ID# 203586
      • Reims, France, 51100
        • Polyclinique Courlancy /ID# 203588
      • Toulouse, France, 31059
        • Hopital Larrey - CHU de Toulouse /ID# 203587
    • Seine-Maritime
      • Rouen CEDEX, Seine-Maritime, France, 76031
        • Charles Nicolle CHU Rouen /ID# 203590
  • Germany
      • Munich, Germany, 80802
        • TU Uniklinik Munchen /ID# 203919
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Policlinico A. Gemelli /ID# 203009
    • Lombardia
      • Milan, Lombardia, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 204982
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboud Universitair Medisch Centrum /ID# 202560
    • Noord-Brabant
      • Bergen op Zoom, Noord-Brabant, Netherlands, 4624 VT
        • Bravis Ziekenhuis /ID# 205232
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Academisch Medical center Amsterdam /ID# 202556
  • Poland
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-265
        • Dermed Centrum Medyczne Sp. z o.o /ID# 203171
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-302
        • Klinika Dermatologii Pod Fortem /ID# 204180
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 01-817
        • Przychodnia Specjalistyczna High-Med /ID# 203183
      • Warsaw, Mazowieckie, Poland, 02-758
        • Klinika Ambroziak Sp. z o.o. /ID# 203928
    • Podkarpackie
      • Rzeszow, Podkarpackie, Poland, 35-055
        • KSW nr1 w Rzeszowie /ID# 203776
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-351
        • Osteo-Medic S.C. /ID# 203742
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario Alicante /ID# 203764
      • Granada, Spain, 18016
        • Hospital Universitario Clinico San Cecilio /ID# 203760
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa /ID# 203754
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 203756
      • Valencia, Spain, 46015
        • Hospital Universitario Arnau Vilanova /ID# 203763
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises /ID# 203757
  • United Kingdom
      • Salford, United Kingdom, M6 8HD
        • The University of Manchester /ID# 204720
    • London, City Of
      • London, London, City Of, United Kingdom, E11 1NR
        • Whipps Cross Univ Hospital /ID# 204723
      • London, London, City Of, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Found /ID# 204721
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Advanced Research Associates - Glendale /ID# 204335
      • Phoenix, Arizona, United States, 85032
        • Alliance Dermatology and MOHs /ID# 204336
    • California
      • Bakersfield, California, United States, 93309
        • Bakersfield Derma & Skin Cance /ID# 202115
      • Fremont, California, United States, 94538
        • Center for Dermatology Clin Res /ID# 202116
      • Los Angeles, California, United States, 90045
        • Dermatology Res. Assoc., CA /ID# 202170
      • Sacramento, California, United States, 95816
        • UC Davis Health /ID# 202263
      • San Diego, California, United States, 92103
        • Medderm Associates /ID# 202162
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • UConn Health Main /ID# 201745
    • Florida
      • North Miami Beach, Florida, United States, 33162-4708
        • Tory P Sullivan, MD PA /ID# 202177
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research /ID# 202113
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research /ID# 202183
      • West Palm Beach, Florida, United States, 33406-6063
        • Integrated Clinical Research LLC /ID# 202152
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Dermatology Specialists Resear /ID# 202145
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Dermatology and Skin Cancer Specialists, LLC /ID# 203938
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • ORA, Inc. /ID# 204342
      • Boston, Massachusetts, United States, 02215-5400
        • Beth Israel Deaconess Medical Center /ID# 204340
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Minnesota Clinical Study Center /ID# 202369
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology, PC /ID# 202156
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Psoriasis Treatment Ctr of Central NJ /ID# 202107
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Synexus Research Cincinnati /ID# 202161
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Derm & Res. Ctr /ID# 201652
      • Portland, Oregon, United States, 97223
        • Oregon Medical Res Center PC /ID# 201651
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners, LLC /ID# 201736
    • Texas
      • Houston, Texas, United States, 77004-8097
        • Center for Clinical Studies - Houston (Binz) /ID# 202178
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research /ID# 202155
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies - Webster TX /ID# 202154
    • Utah
      • Salt Lake City, Utah, United States, 84112-5500
        • University of Utah /ID# 204035
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Mem Lutheran Hosp /ID# 204896

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Drug: risankizumab
Subcutaneous (SC) injection
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI
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.
Drug: secukinumab
Subcutaneous (SC) injection
Other Names:
  • Cosentyx

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
Week 16
Percentage of Participants With a PASI 90 at Week 52
Time Frame: 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.
Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
Week 52
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52
Time Frame: 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.
Week 52
Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52
Time Frame: 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.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Psoriasis

Clinical Trials on risankizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings