Psoriasis
Conditions
Keywords
Psoriasis, Plaque Psoriasis, Moderate to Severe Plaque Psoriasis, Plaque Psoriasis with Palmoplantar (Non-Pustular) Involvement (PPPsO), Risankizumab, SKYRIZI, ABBV-066
Brief summary
Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms. Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world. Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
Subcutaneous (SC) Injection
DRUGRisankizumab
Subcutaneous (SC) Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or without psoriatic arthritis) for at least 6 months before Baseline and a Palmoplantar Investigator's Global Assessment (ppIGA) of moderate or severe, at Screening and Baseline. * Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA) involvement of greater than or equal to one percent, an Static Physician's Global Assessment (sPGA) score of moderate to severe (greater than or equal to three), a PPASI moderate to severe (greater than or equal to eight), at least one additional PsO plaque outside of the palms and soles. * Must be a candidate for systemic therapy as assessed by the investigator. * Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.
Exclusion criteria
* History of PsO other than chronic plaque type PsO * History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis. * Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with PsO assessments. * Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV), Active tuberculosis, Active systemic infection/clinically important infections in the last two weeks prior to Baseline. * Prior exposure to risankizumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of Clear or Almost Clear (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 | Baseline, Week 16 | The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being clear and 1 being almost clear. |
| Number of Participants With Treatment-Emergent Adverse Events | From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16 | Baseline, Week 16 | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease. |
| Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16 | Baseline, Week 16 | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease. |
| Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 | Baseline, Week 16 | 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. Higher scores indicate more severe disease. |
| Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16 | Baseline, Week 16 | PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease. |
Countries
Canada, Puerto Rico, Spain, United States
Participant flow
Pre-assignment details
Eligible participants were randomized at the Baseline visit in a 1:1 ratio to receive either risankizumab 150 mg as a single SC injection, or matching placebo during the Double-blind Period. Study drug administration occurred at Baseline and Week 4. Starting at Week 16, participants received open-label risankizumab 150 mg once every 12 weeks (q12w) at Weeks 16, 28, and 40. The final efficacy evaluation took place at Week 52.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. | 87 |
| Risankizumab Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40. | 87 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-blind Period (Baseline - Week 16) | Adverse Event | 0 | 1 | 0 | 0 |
| Double-blind Period (Baseline - Week 16) | Withdrawal by Subject | 6 | 2 | 0 | 0 |
| Open-label Period (Week 16 - Week 52) | Adverse Event | 0 | 0 | 1 | 2 |
| Open-label Period (Week 16 - Week 52) | Lack of Efficacy | 0 | 0 | 1 | 1 |
| Open-label Period (Week 16 - Week 52) | Lost to Follow-up | 0 | 0 | 1 | 1 |
| Open-label Period (Week 16 - Week 52) | Other, not specified | 0 | 0 | 16 | 14 |
| Open-label Period (Week 16 - Week 52) | Withdrawal by Subject | 0 | 0 | 3 | 5 |
Baseline characteristics
| Characteristic | Placebo | Risankizumab | Total |
|---|---|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 14.3 | 56.9 years STANDARD_DEVIATION 12.93 | 55.4 years STANDARD_DEVIATION 13.67 |
| Baseline PPASI score | 22.46 units on a scale STANDARD_DEVIATION 12.141 | 22.48 units on a scale STANDARD_DEVIATION 13.647 | 22.47 units on a scale STANDARD_DEVIATION 12.878 |
| Baseline ppIGA score Almost Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline ppIGA score Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline ppIGA score Mild | 0 Participants | 0 Participants | 0 Participants |
| Baseline ppIGA score Moderate | 68 Participants | 67 Participants | 135 Participants |
| Baseline ppIGA score Severe | 19 Participants | 20 Participants | 39 Participants |
| Baseline sPGA score Almost Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline sPGA score Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline sPGA score Mild | 0 Participants | 0 Participants | 0 Participants |
| Baseline sPGA score Moderate | 75 Participants | 77 Participants | 152 Participants |
| Baseline sPGA score Severe | 12 Participants | 10 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 28 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 59 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 9 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 74 Participants | 74 Participants | 148 Participants |
| Sex: Female, Male Female | 45 Participants | 40 Participants | 85 Participants |
| Sex: Female, Male Male | 42 Participants | 47 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 87 | 0 / 81 | 1 / 84 |
| other Total, other adverse events | 2 / 87 | 2 / 87 | 8 / 81 | 12 / 84 |
| serious Total, serious adverse events | 0 / 87 | 5 / 87 | 0 / 81 | 5 / 84 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time frame: From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks)
Population: All participants who were randomized and received at least 1 dose of study drug in the Double-blind Period; all participants who received at least 1 dose of study drug in the Open-label Period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events | Any TEAE | 20 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events | TESAE | 0 Participants |
| Risankizumab | Number of Participants With Treatment-Emergent Adverse Events | TESAE | 5 Participants |
| Risankizumab | Number of Participants With Treatment-Emergent Adverse Events | Any TEAE | 25 Participants |
| Placebo/Risankizumab | Number of Participants With Treatment-Emergent Adverse Events | Any TEAE | 29 Participants |
| Placebo/Risankizumab | Number of Participants With Treatment-Emergent Adverse Events | TESAE | 0 Participants |
| Risankizumab/Risankizumab | Number of Participants With Treatment-Emergent Adverse Events | Any TEAE | 40 Participants |
| Risankizumab/Risankizumab | Number of Participants With Treatment-Emergent Adverse Events | TESAE | 5 Participants |
Primary
Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of Clear or Almost Clear (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16
The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being clear and 1 being almost clear.
Time frame: Baseline, Week 16
Population: Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of Clear or Almost Clear (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 | 16.1 percentage of participants |
| Risankizumab | Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of Clear or Almost Clear (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 | 33.3 percentage of participants |
Comparison: Risankizumab vs Placebo at Week 16p-value: =0.00695% CI: [5, 29.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16
PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.
Time frame: Baseline, Week 16
Population: Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16 | 1.1 percentage of participants |
| Risankizumab | Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16 | 17.2 percentage of participants |
Comparison: Risankizumab vs Placebo at Week 16p-value: <0.00195% CI: [8.2, 24.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16
PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.
Time frame: Baseline, Week 16
Population: Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16 | 14.9 percentage of participants |
| Risankizumab | Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16 | 42.5 percentage of participants |
Comparison: Risankizumab vs Placebo at Week 16p-value: <0.00195% CI: [15.4, 39.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16
PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.
Time frame: Baseline, Week 16
Population: Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16 | 5.7 percentage of participants |
| Risankizumab | Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16 | 27.6 percentage of participants |
Comparison: Risankizumab vs Placebo at Week 16p-value: <0.00195% CI: [11.5, 32.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16
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. Higher scores indicate more severe disease.
Time frame: Baseline, Week 16
Population: Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 | 11.5 percentage of participants |
| Risankizumab | Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 | 32.2 percentage of participants |
Comparison: Risankizumab vs Placebo at Week 16p-value: <0.00195% CI: [9.1, 32.2]Cochran-Mantel-Haenszel