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A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03875508
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The objectives of this study are to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of participants with moderate to severe plaque psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Risankizumab Device: Autoinjector Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-Arm, Open Label, Assessor-Blinded Study to Assess the Usability of the Risankizumab Autoinjector Combination Product in Adult Patients With Moderate to Severe Plaque Psoriasis
Estimated Study Start Date : April 2, 2019
Estimated Primary Completion Date : March 2, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Risankizumab Autoinjector
Participants will be self-administering risankizumab using a pre-filled autoinjector
Drug: Risankizumab
Risankizumab to be injected subcutaneously (SC)
Other Names:
  • ABBV-066
  • BI 655066

Device: Autoinjector
Single dose pre-filled autoinjector containing risankizumab for SC injection




Primary Outcome Measures :
  1. Percentage of participants with an Observer rating of successful participant self-administration [ Time Frame: Up to Week 28 ]
    Successful participant self-administration is defined as any participants who successfully completed the sequence of 4 critical steps in the Instructions for Use (IFU) without errors to administer study drug via the AI.

  2. Percentage of participants achieving Psoriasis Area Severity Index (PASI) 90 [ Time Frame: At Week 16 ]
    PASI 90 is defined as at least 90% improvement from baseline in PASI.

  3. Percentage of participants achieving static physician global assessment (sPGA) of clear or almost clear [ Time Frame: At Week 16 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  4. Percentage of participants achieving PASI 100 [ Time Frame: At Week 16 ]
    PASI 100 is defined as 100% improvement from baseline in PASI.

  5. Percentage of participants achieving PASI 75 [ Time Frame: At Week 16 ]
    PASI 75 is defined as at least 75% improvement from baseline in PASI.

  6. Percentage of participants who had no potential hazards [ Time Frame: Up to Week 28 ]
    Potential hazards are measured by an observer on the possible use-related hazards checklist for self-administration with AI.

  7. Participant rating of acceptability by the Self-Injection Assessment Questionnaire (SIAQ) [ Time Frame: Up to Week 28 ]
    SIAQ is an electronic patient-report outcome (ePRO) device used to measure acceptability of the AI.



Information from the National Library of Medicine

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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:

  • Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
  • Participant meets following disease activity criteria:

    • Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
    • Candidate for systemic therapy as assessed by the investigator.

Exclusion Criteria:

  • Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
  • Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
  • Participant has previous exposure to risankizumab.

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): NCT03875508


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

Locations
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United States, Arizona
Advanced Research Associates /ID# 210634 Not yet recruiting
Glendale, Arizona, United States, 85308
United States, California
Tien Q Nguyen MD, Inc /ID# 210775 Not yet recruiting
Fountain Valley, California, United States, 92708-3701
Center for Dermatology Clin Res /ID# 210319 Not yet recruiting
Fremont, California, United States, 94538
UC Davis, Dermatology /ID# 210411 Not yet recruiting
Sacramento, California, United States, 95816
United States, Florida
Florida Academic Centers Research /ID# 210337 Not yet recruiting
Coral Gables, Florida, United States, 33134
Sullivan Dermatology /ID# 210338 Not yet recruiting
North Miami Beach, Florida, United States, 33162-4708
United States, Ohio
Rapid Medical Research, INC /ID# 210207 Not yet recruiting
Cleveland, Ohio, United States, 44122
United States, Oregon
Oregon Medical Res Center PC /ID# 210334 Not yet recruiting
Portland, Oregon, United States, 97223
United States, Rhode Island
Rhode Island Hospital /ID# 210639 Not yet recruiting
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03875508     History of Changes
Other Study ID Numbers: M16-005
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by AbbVie:
Psoriasis
Risankizumab
Plaque Psoriasis

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