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 : Completed
First Posted : March 14, 2019
Last Update Posted : September 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Risankizumab Device: Autoinjector||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Risankizumab autoinjector
Participants will be self-administering risankizumab using a pre-filled autoinjector
Risankizumab to be injected subcutaneously (SC)
Single dose pre-filled autoinjector containing risankizumab for SC injection
- 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.
- 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.
- 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.
- Percentage of participants achieving PASI 100 [ Time Frame: At Week 16 ]PASI 100 is defined as 100% improvement from baseline in PASI.
- Percentage of participants achieving PASI 75 [ Time Frame: At Week 16 ]PASI 75 is defined as at least 75% improvement from baseline in PASI.
- 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.
- 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.
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
|Study Director:||AbbVie Inc.||AbbVie|