A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Part of paid clinical trials in Glendale, Arizona.
- Sponsor
- AbbVie
- Study ID
- NCT03875508
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Risankizumab — DRUGRisankizumab to be injected subcutaneously (SC)
- Autoinjector — DEVICESingle dose pre-filled autoinjector containing risankizumab for SC injection
Study Details
The objectives of this study were 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 adult participants with moderate to severe plaque psoriasis.
Key Dates
- Start date
- Jun 4, 2019
- Status verified
- Apr 2021
- Primary completion
- Apr 24, 2020
- Completion
- Aug 25, 2020
Study Design
- Enrollment
- 108 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: RisankizumabRisankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Primary Outcome Measure
Percentage of Participants With an Observer Rating of Successful Participant Self-administration [ Time Frame: Day 1 and Week 28 ]
Locations (26)
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