Psoriasis
Conditions
Keywords
Psoriasis, Risankizumab, Plaque Psoriasis
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.
Interventions
DRUGRisankizumab
Risankizumab to be injected subcutaneously (SC)
DEVICEAutoinjector
Single dose pre-filled autoinjector containing risankizumab for SC injection
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16 | Baseline, Week 4, and 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. |
Countries
United States
Participant flow
Pre-assignment details
Intent-to-treat (ITT) population: all participants who received at least one dose of study drug
Participants by arm
| Arm | Count |
|---|---|
| Risankizumab Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28 | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Other, not specified | 2 |
Baseline characteristics
| Characteristic | Risankizumab |
|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 14.32 |
| Body Surface Area (BSA) Psoriasis Involvement at Baseline | 25.471 Percentage of body surface area affected STANDARD_DEVIATION 17.4671 |
| Duration of Plaque Psoriasis | 16.89 years STANDARD_DEVIATION 13.095 |
| Prior Use of Systemic Biologic for Psoriasis 0 | 60 Participants |
| Prior Use of Systemic Biologic for Psoriasis ≥1 | 48 Participants |
| Psoriasis Area and Severity Index (PASI) Score at Baseline | 19.834 units on a scale STANDARD_DEVIATION 7.2424 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 95 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 66 Participants |
| Static Physician Global Assessment (sPGA) Score at Baseline Score of 3 | 88 Participants |
| Static Physician Global Assessment (sPGA) Score at Baseline Score of 4 | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 108 |
| other Total, other adverse events | 12 / 108 |
| serious Total, serious adverse events | 6 / 108 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) | Injection-site reactions- Week 4 | 9.700 units on a scale | Standard Deviation 0.571 |
| Risankizumab | Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ) | Ease of use- Week 4 | 8.84 units on a scale | Standard Deviation 1.24 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 1.05 |
| Risankizumab | 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 |
| Risankizumab | 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 |
| Risankizumab | 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 |
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Risankizumab | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16 | 46.3 percentage of participants |
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Risankizumab | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 at Week 16 | 84.3 percentage of participants |
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Risankizumab | Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 | 66.7 percentage of participants |
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Risankizumab | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16 | 81.5 percentage of participants |
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab | Percentage of Participants Who Had No Potential Hazards as Measured by an Observer | Day 1 | 100 percentage of participants |
| Risankizumab | Percentage of Participants Who Had No Potential Hazards as Measured by an Observer | Week 28 | 100 percentage of participants |
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.
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab | Percentage of Participants With an Observer Rating of Successful Participant Self-administration | Day 1 | 100 percentage of participants |
| Risankizumab | Percentage of Participants With an Observer Rating of Successful Participant Self-administration | Week 28 | 100 percentage of participants |
Other Pre-specified
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.
Time frame: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Risankizumab | Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16 | Week 16 | -89.33 percent change from Baseline |
| Risankizumab | Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16 | Week 4 | -61.57 percent change from Baseline |