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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875508
• Other study ID #: M16-005
• Status: Completed
• Phase: Phase 3
• Start date: June 4, 2019
• Est. completion date: August 25, 2020

Study information

• Verified date: April 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 25, 2020
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Risankizumab
Risankizumab to be injected subcutaneously (SC)

Device:
• Autoinjector
Single dose pre-filled autoinjector containing risankizumab for SC injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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