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

Plaque Psoriasis: Usability of the Risankizumab Autoinjector Combination Product in Adults With Moderate to Severe Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Risankizumab; Device: Autoinjector

Detailed Description

This was a Phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-AI combination product. The study included a 30-day screening period with study visits at Weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (Week 48). Study drug dosing consisted of 4 self-administered doses given subcutaneously on Weeks 0, 4, 16, and 28. Dosing on Weeks 4 and 16 was self-administered at home.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates /ID# 210634
    • Scottsdale, Arizona, United States, 85258-4446
      • Cognitive Clinical Trials /ID# 210770
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913-6404
      • Burke Pharmaceutical Research /ID# 211386
  • California
    • Bakersfield, California, United States, 93309
      • Bakersfield Derma & Skin Cance /ID# 210773
    • Encino, California, United States, 91436
      • Encino Research Center / T. Jo /ID# 211735
    • Fountain Valley, California, United States, 92708-3701
      • Tien Q Nguyen MD, Inc /ID# 210775
    • Sacramento, California, United States, 95816
      • UC Davis Health /ID# 210411
  • Connecticut
    • Shelton, Connecticut, United States, 06484-6211
      • Dermatology Physicians of CT /ID# 210637
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Centers Research /ID# 210337
    • Naples, Florida, United States, 34102
      • Medallion Clinical Research Institute, LLC /ID# 210329
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research /ID# 210878
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Epiphany Dermatology /ID# 211493
  • Maryland
    • Rockville, Maryland, United States, 20850
      • DermAssociates /ID# 210838
  • Michigan
    • Bay City, Michigan, United States, 48602
      • Great Lakes Research, Inc. /ID# 210192
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre /ID# 211596
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology, PC /ID# 210301
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • AllCutis Research Inc /ID# 211429
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Medication Management, LLC /ID# 213217
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Res Center PC /ID# 210334
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 210839
  • Texas
    • Cypress, Texas, United States, 77433
      • Center for Clinical Studies /ID# 211565
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies /ID# 210362
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates /ID# 212210
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research /ID# 212203
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research /ID# 212209
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Mem Lutheran Hosp /ID# 210194

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risankizumab; Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28	Drug: Risankizumab; Risankizumab to be injected subcutaneously (SC); Other Names: BI 655066; ABBV-066; Device: Autoinjector; Single dose pre-filled autoinjector containing risankizumab for SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Observer Rating of Successful Participant Self-administration	Successful participant self-administration is defined as successfully completed the sequence of 4 critical steps in the Instructions for Use (IFU) without errors to administer study drug via the autoinjector. The steps are "chose an appropriate injection site"; "removed cap from autoinjector"; "activated the injection"; and "performed a complete injection".	Day 1 and Week 28
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.	At Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.	At Week 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.	At Week 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.	At Week 16
Percentage of Participants Who Had No Potential Hazards as Measured by an Observer	Potential hazards are measured by an observer on the possible use-related hazards checklist for self-administration with the autoinjector. Hazards include injection at incorrect site; administration delayed because of cap removal difficulties; slip hazard during cap disposal attempt; small component swallowed after incorrect disposal of cap; patient received less medication than intended; needle shield did not deploy and resulted in sharps exposure; and pen not discarded properly and resulted in a biohazard for others.	Day 1 and Week 28
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ)	Participants completed the Self-Injection Assessment Questionnaire (SIAQ), an instrument previously validated in those with rheumatoid arthritis, on an electronic patient-report outcome (ePRO) device. The POST module includes four principal causal domains: feelings about injections, self-confidence, pain and reaction during or after the injection, and ease of use, plus two additional domains on satisfaction with self-injection and self-image. Participants rate each item of the SIAQ 20 to 40 minutes following injections, and the ratings are transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Higher domain scores indicate wider acceptability by subjects to use the autoinjector.	Day 1, Week 4, Week 16, Week 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Negative values indicate an improvement from baseline.	Baseline, Week 4, and Week 16

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Actual): April 24, 2020
• Study Completion (Actual): August 25, 2020

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Psoriasis; Plaque Psoriasis; Risankizumab
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: M16-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes