Plaque Psoriasis
Conditions
Keywords
Plaque Psoriasis Risankizumab Secukinumab Ixekizumab Psoriasis Biologic
Brief summary
This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms. Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.
Interventions
DRUGRisankizumab
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
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
* Diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before Baseline (Week 0). * Participant must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing suboptimal response at time of Screening and Baseline visits. * Participant must have a Body Surface Area (BSA) 3%- \<10% and Static Physician Global Assessment (sPGA) 2/3 * Participant must be eligible for continued biologic therapy as assessed by the investigator.
Exclusion criteria
* History of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis, psoriatic arthritis. * Participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis. * History of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix. * History of major surgery within 12 weeks prior to Baseline or planned to be performed during the conduct of the trial as assessed by the investigator. * Participant with exposure to risankizumab or any IL-23 inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 | At Week 16 | The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1 | At Week 16 | The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life. |
| Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0 | At Week 16 | The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe). |
| Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 | At Week 52 | The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear. |
| Proportion of Participants Achieving a sPGA Clear Response (sPGA 0) | At Week 16 | The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear. |
| Time to Achieve sPGA 0/1 | Up to Week 52 | The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear. |
| Time to Achieve sPGA 0 | Up to Week 52 | The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear. |
| Proportion of Participants Achieving a PSS 0 | At Week 52 | The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe). |
Countries
Australia, Germany, Israel, Italy, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
Significant site non-compliance for this study was identified at one site since interim results were posted. As a result of this finding, participants enrolled in this trial site were not included in any final analysis. Adverse events or lab abnormalities were reported in 1 participant from this site. The participant was on risankizumab and had a non serious event of headache (assessed as mild), which did not lead to study drug discontinuation
Participants by arm
| Arm | Count |
|---|---|
| Risankizumab Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS) | 244 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Eligibility Violation | 5 |
| Overall Study | Lack of Efficacy | 6 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Compliance | 1 |
| Overall Study | Protocol Deviation | 5 |
| Overall Study | Withdrawal by Subject | 12 |
| Overall Study | Withdrew Treatment | 2 |
Baseline characteristics
| Characteristic | Risankizumab |
|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 12.81 |
| Age, Customized 40 - 65 years | 150 Participants |
| Age, Customized < 40 years | 65 Participants |
| Age, Customized ≥ 65 years | 29 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 227 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 27 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 214 Participants |
| Region of Enrollment Australia | 3 participants |
| Region of Enrollment Germany | 65 participants |
| Region of Enrollment Israel | 34 participants |
| Region of Enrollment Italy | 27 participants |
| Region of Enrollment Spain | 17 participants |
| Region of Enrollment Taiwan | 22 participants |
| Region of Enrollment United Kingdom | 12 participants |
| Region of Enrollment United States | 64 participants |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 244 |
| other Total, other adverse events | 31 / 244 |
| serious Total, serious adverse events | 17 / 244 |
Outcome results
Primary
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: At Week 16
Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risankizumab | Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 | 140 Participants |
95% CI: [51.1, 63.4]Other
Secondary
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1
The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
Time frame: At Week 52
Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risankizumab | Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1 | 115 Participants |
95% CI: [41, 53.4]Other
Secondary
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1
The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
Time frame: At Week 16
Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risankizumab | Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1 | 98 Participants |
95% CI: [34.2, 46.4]Other
Secondary
Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0
The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).
Time frame: At Week 16
Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risankizumab | Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0 | 51 Participants |
95% CI: [16.3, 26.4]Other
Secondary
Proportion of Participants Achieving a PSS 0
The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).
Time frame: At Week 52
Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risankizumab | Proportion of Participants Achieving a PSS 0 | 67 Participants |
95% CI: [22.3, 33.4]Other
Secondary
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: At Week 52
Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risankizumab | Proportion of Participants Achieving a sPGA Clear Response (sPGA 0) | 66 Participants |
95% CI: [21.9, 33]Other
Secondary
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0)
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: At Week 16
Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risankizumab | Proportion of Participants Achieving a sPGA Clear Response (sPGA 0) | 50 Participants |
95% CI: [15.4, 26]Other
Secondary
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: At Week 52
Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risankizumab | Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 | 152 Participants |
95% CI: [56, 68.1]Other
Secondary
Time to Achieve sPGA 0
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: Up to Week 52
Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab | Time to Achieve sPGA 0 | 25th | 121 Days |
| Risankizumab | Time to Achieve sPGA 0 | Median | 370 Days |
| Risankizumab | Time to Achieve sPGA 0 | 75th | NA Days |
Secondary
Time to Achieve sPGA 0/1
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Time frame: Up to Week 52
Population: Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Risankizumab | Time to Achieve sPGA 0/1 | 25th | 30 Days |
| Risankizumab | Time to Achieve sPGA 0/1 | Median | 57 Days |
| Risankizumab | Time to Achieve sPGA 0/1 | 75th | 199 Days |