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

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Drug: Risankizumab; Device: Autoinjector

• Registration Number: NCT03875508
• Lead Sponsor: AbbVie

Brief 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.

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 Timeline

• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Study Start: 2019-06-04
• Primary Completion: 2020-04-24
• Study Completion: 2020-08-25
• Status Verified: 2021-04
• Results First Submitted: 2021-04-19
• Results First Submitted QC: 2021-04-19
• Last Update Submitted: 2021-04-19
• Results First Posted: 2021-05-11
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Risankizumab	Autoinjector	Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Risankizumab	Risankizumab	Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an Observer Rating of Successful Participant Self-administration	Day 1 and Week 28	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".
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16	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.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16	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.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16	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.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16	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.
Percentage of Participants Who Had No Potential Hazards as Measured by an Observer	Day 1 and Week 28	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.
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ)	Day 1, Week 4, Week 16, Week 28	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.

Trial Locations

Locations (26)

Advanced Research Associates /ID# 210634; 🇺🇸 Glendale, Arizona, United States

Cognitive Clinical Trials /ID# 210770; 🇺🇸 Scottsdale, Arizona, United States

Burke Pharmaceutical Research /ID# 211386; 🇺🇸 Hot Springs, Arkansas, United States

Bakersfield Derma & Skin Cance /ID# 210773; 🇺🇸 Bakersfield, California, 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

UC Davis Health /ID# 210411; 🇺🇸 Sacramento, California, United States

Dermatology Physicians of CT /ID# 210637; 🇺🇸 Shelton, Connecticut, United States

Florida Academic Centers Research /ID# 210337; 🇺🇸 Coral Gables, Florida, United States

Medallion Clinical Research Institute, LLC /ID# 210329; 🇺🇸 Naples, Florida, United States

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