COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 1 of 1 for:    m16-005
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03875508
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : September 7, 2020
Information provided by (Responsible Party):

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: N/A
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
Actual Study Start Date : June 4, 2019
Actual Primary Completion Date : April 24, 2020
Actual Study Completion Date : August 25, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03875508

Show Show 26 study locations
Sponsors and Collaborators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie
Layout table for additonal information
Responsible Party: AbbVie Identifier: NCT03875508    
Other Study ID Numbers: M16-005
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
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)
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.

Layout table for additional information
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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Plaque Psoriasis
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases, Papulosquamous
Skin Diseases