Trial Outcomes & Findings for A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis (NCT NCT03875508)

Last Updated: 2021-05-11

Results Overview

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".

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

108 participants

Primary outcome timeframe

Day 1 and Week 28

Results posted on

2021-05-11

Participant Flow

Intent-to-treat (ITT) population: all participants who received at least one dose of study drug

Participant milestones

Participant milestones
Measure	Risankizumab Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Overall Study STARTED	108
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Risankizumab Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	8
Overall Study Lack of Efficacy	1
Overall Study Other, not specified	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risankizumab n=108 Participants Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Age, Continuous	49.2 years STANDARD_DEVIATION 14.32 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants
Race/Ethnicity, Customized White	95 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants
Prior Use of Systemic Biologic for Psoriasis 0	60 Participants n=5 Participants
Prior Use of Systemic Biologic for Psoriasis ≥1	48 Participants n=5 Participants
Static Physician Global Assessment (sPGA) Score at Baseline Score of 3	88 Participants n=5 Participants
Static Physician Global Assessment (sPGA) Score at Baseline Score of 4	20 Participants n=5 Participants
Psoriasis Area and Severity Index (PASI) Score at Baseline	19.834 units on a scale STANDARD_DEVIATION 7.2424 • n=5 Participants
Body Surface Area (BSA) Psoriasis Involvement at Baseline	25.471 Percentage of body surface area affected STANDARD_DEVIATION 17.4671 • n=5 Participants
Duration of Plaque Psoriasis	16.89 years STANDARD_DEVIATION 13.095 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and Week 28

Population: Intent-to-treat (ITT) population: all participants who received at least one dose of study drug and had available data

Outcome measures

Outcome measures
Measure	Risankizumab n=104 Participants Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Percentage of Participants With an Observer Rating of Successful Participant Self-administration Day 1	100 percentage of participants
Percentage of Participants With an Observer Rating of Successful Participant Self-administration Week 28	100 percentage of participants

PRIMARY outcome

Timeframe: At Week 16

Population: Intent-to-treat (ITT) population: all participants who received at least one dose of study drug; those with missing data were imputed as non-responders

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.

Outcome measures

Outcome measures
Measure	Risankizumab n=108 Participants Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16	66.7 percentage of participants Interval 57.8 to 75.6

PRIMARY outcome

Timeframe: At Week 16

Population: Intent-to-treat (ITT) population: all participants who received at least one dose of study drug; those with missing data were imputed as non-responders

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.

Outcome measures

Outcome measures
Measure	Risankizumab n=108 Participants Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16	81.5 percentage of participants Interval 74.2 to 88.8

PRIMARY outcome

Timeframe: At Week 16

Population: Intent-to-treat (ITT) population: all participants who received at least one dose of study drug; those with missing data were imputed as non-responders

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.

Outcome measures

Outcome measures
Measure	Risankizumab n=108 Participants Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16	46.3 percentage of participants Interval 36.9 to 55.7

PRIMARY outcome

Timeframe: At Week 16

Population: Intent-to-treat (ITT) population: all participants who received at least one dose of study drug; those with missing data were imputed as non-responders

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.

Outcome measures

Outcome measures
Measure	Risankizumab n=108 Participants Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16	84.3 percentage of participants Interval 77.4 to 91.1

PRIMARY outcome

Timeframe: Day 1 and Week 28

Population: Intent-to-treat (ITT) population: all participants who received at least one dose of study drug and had available data

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.

Outcome measures

Outcome measures
Measure	Risankizumab n=103 Participants Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Percentage of Participants Who Had No Potential Hazards as Measured by an Observer Day 1	100 percentage of participants
Percentage of Participants Who Had No Potential Hazards as Measured by an Observer Week 28	100 percentage of participants

PRIMARY outcome

Timeframe: Day 1, Week 4, Week 16, Week 28

Population: Intent-to-treat (ITT) population: all participants who received at least one dose of study drug and had available data

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.

Outcome measures

Outcome measures
Measure	Risankizumab n=101 Participants Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Feelings about injections- Day 1	8.358 units on a scale Standard Deviation 2.3613
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Self-confidence- Day 1	8.556 units on a scale Standard Deviation 2.0646
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Satisfaction with self-injection- Day 1	9.056 units on a scale Standard Deviation 1.0321
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Injection-site reactions- Day 1	9.817 units on a scale Standard Deviation 0.4469
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Ease of use- Day 1	8.82 units on a scale Standard Deviation 1.415
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Self-image- Day 1	9.53 units on a scale Standard Deviation 1.261
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Feelings about injections- Week 4	8.478 units on a scale Standard Deviation 2.0024
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Self-confidence- Week 4	8.112 units on a scale Standard Deviation 2.6313
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Satisfaction with self-injection- Week 4	9.096 units on a scale Standard Deviation 1.1572
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Injection-site reactions- Week 4	9.700 units on a scale Standard Deviation 0.5710
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Ease of use- Week 4	8.84 units on a scale Standard Deviation 1.240
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Self-image- Week 4	9.16 units on a scale Standard Deviation 1.964
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Feelings about injections- Week 16	8.750 units on a scale Standard Deviation 1.8483
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Self-confidence- Week 16	8.367 units on a scale Standard Deviation 2.5921
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Satisfaction with self-injection- Week 16	9.229 units on a scale Standard Deviation 1.1517
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Injection-site reactions- Week 16	9.763 units on a scale Standard Deviation 0.4576
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Ease of use- Week 16	8.93 units on a scale Standard Deviation 1.394
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Self-image- Week 16	9.28 units on a scale Standard Deviation 1.678
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Feelings about injections- Week 28	8.675 units on a scale Standard Deviation 2.0661
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Self-confidence- Week 28	8.795 units on a scale Standard Deviation 2.3034
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Satisfaction with self-injection- Week 28	9.458 units on a scale Standard Deviation 1.0500
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Injection-site reactions- Week 28	9.725 units on a scale Standard Deviation 0.8911
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Ease of use- Week 28	9.39 units on a scale Standard Deviation 0.971
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) Self-image- Week 28	9.34 units on a scale Standard Deviation 1.614

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 4, and Week 16

Population: Intent-to-treat (ITT) population: all randomized participants with a non-missing baseline measurement and at least one post-baseline value

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.

Outcome measures

Outcome measures
Measure	Risankizumab n=107 Participants Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16 Week 4	-61.57 percent change from Baseline Interval -66.502 to -56.636
Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16 Week 16	-89.33 percent change from Baseline Interval -92.915 to -85.75

Adverse Events

Risankizumab

Serious events: 6 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Risankizumab n=108 participants at risk Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Cardiac disorders ATRIAL FIBRILLATION	0.93% 1/108 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks after last study drug administration, up to 48 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent. TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders PYREXIA	0.93% 1/108 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks after last study drug administration, up to 48 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent. TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations APPENDICITIS	0.93% 1/108 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks after last study drug administration, up to 48 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent. TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PYELONEPHRITIS	0.93% 1/108 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks after last study drug administration, up to 48 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent. TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications THERMAL BURN	0.93% 1/108 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks after last study drug administration, up to 48 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent. TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.93% 1/108 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks after last study drug administration, up to 48 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent. TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders PROSTATITIS	0.93% 1/108 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks after last study drug administration, up to 48 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent. TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Other adverse events
Measure	Risankizumab n=108 participants at risk Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28
Infections and infestations NASOPHARYNGITIS	7.4% 8/108 • Number of events 8 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks after last study drug administration, up to 48 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent. TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.6% 6/108 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks after last study drug administration, up to 48 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent. TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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