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Risankizumab Versus Secukinumab for Subjects With Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03478787
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: risankizumab Drug: secukinumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : November 29, 2019
Estimated Study Completion Date : June 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Risankizumab
Risankizumab administered by subcutaneous (SC) injection.
Drug: risankizumab
Subcutaneous (SC) injection.
Other Names:
  • ABBV-066
  • BI 655066

Active Comparator: Secukinumab
Secukinumab administered by subcutaneous (SC) injection.
Drug: secukinumab
Subcutaneous (SC) injection.




Primary Outcome Measures :
  1. Percentage of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 52 [ Time Frame: Week 52 ]
    PASI 90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  2. Percentage of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 [ Time Frame: Week 16 ]
    PASI 90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.


Secondary Outcome Measures :
  1. Percentage of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52 [ Time Frame: Week 52 ]
    PASI 100 denotes greater than or equal to 100% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.

  2. Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 52 [ Time Frame: Week 52 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  3. Percentage of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52 [ Time Frame: Week 52 ]
    PASI 75 denotes greater than or equal to 75% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity of erythema, induration, and scale, weighted by body part.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 /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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478787


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03478787     History of Changes
Other Study ID Numbers: M16-766
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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

Keywords provided by AbbVie:
Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs