A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT03875482|
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : July 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Risankizumab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis|
|Actual Study Start Date :||May 13, 2019|
|Actual Primary Completion Date :||February 20, 2020|
|Actual Study Completion Date :||July 15, 2020|
Participants randomized to receive risankizumab
Risankizumab is administered as subcutaneous (SC) injection
Participants randomized to receive placebo for risankizumab
Placebo for risankizumab is administered as subcutaneous (SC) injection
- 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 static Physician Global Assessment (sPGA) of 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
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): NCT03875482
|Study Director:||AbbVie Inc.||AbbVie|