Psoriasis
Conditions
Keywords
BI 655066, ABBV-066, risankizumab
Brief summary
This is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).
Detailed description
Participants were randomized to receive either placebo, risankizumab 75 mg, or risankizumab 150 mg in Part A. All participants received 2 injections to maintain the blind: the placebo arm received 2 injections of placebo, the risankizumab 75 mg arm received one injection of risankizumab 75 mg and one injection of placebo, and the risankizumab 150 mg arm received 2 injections of risankizumab 75 mg. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received risankizumab (75 mg or 150 mg) in Part A continued to receive the same treatment (risankizumab 75 mg or 150 mg) in Part B.
Interventions
DRUGrisankizumab
Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
Sponsors
Boehringer Ingelheim
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient. * Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation): 1. Have an involved body surface area (BSA) ≥10% and 2. Have a Psoriasis Area and Severity Index (PASI) score ≥12 and 3. Have a Static Physician Global Assessment (sPGA) score of ≥3.
Exclusion criteria
* Patients with 1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular) 2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) 3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment * Previous exposure to BI 655066
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) | Week 16 | 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. PASI90 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) | Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) 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. Nonresponder imputation (NRI) was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B) | Week 52 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) 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. Nonresponder imputation (NRI) was used for missing data. |
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A) | Week 16 | 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. PASI75 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data. |
| Percentage of Participants Achieving PASI75 at Week 52 (Part B) | Week 52 | 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. PASI75 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data. |
| Percentage of Participants Achieving PASI90 at Week 52 (Part B) | Week 52 | 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. PASI90 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data. |
| Percentage of Participants Achieving PASI100 at Week 52 (Part B) | Week 52 | 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. PASI100 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data. |
| Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A) | Week 16 | Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data. |
| Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B) | Week 52 | Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data. |
| Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A) | Week 16 | 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. PASI100 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data. |
Participant flow
Pre-assignment details
A total of 182 subjects were enrolled; 11 subjects failed screening and are excluded from the analyses.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Part A) Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). | 58 |
| Risankizumab 75 mg (Part A) Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). | 58 |
| Risankizumab 150 mg (Part A) Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). | 55 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Part A | Adverse Event | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Part B | Not dosed due to AE | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo (Part A) | Risankizumab 75 mg (Part A) | Risankizumab 150 mg (Part A) | Total |
|---|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 11.24 | 51.5 years STANDARD_DEVIATION 12.33 | 53.3 years STANDARD_DEVIATION 11.94 | 51.9 years STANDARD_DEVIATION 11.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 58 Participants | 55 Participants | 171 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 58 Participants | 58 Participants | 55 Participants | 171 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 5 Participants | 28 Participants |
| Sex: Female, Male Male | 45 Participants | 48 Participants | 50 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 58 | 0 / 55 | 0 / 27 | 0 / 27 | 0 / 56 | 0 / 54 |
| other Total, other adverse events | 22 / 58 | 14 / 58 | 14 / 55 | 10 / 27 | 19 / 27 | 23 / 56 | 19 / 54 |
| serious Total, serious adverse events | 1 / 58 | 2 / 58 | 2 / 55 | 2 / 27 | 0 / 27 | 1 / 56 | 1 / 54 |
Outcome results
Primary
Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
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. PASI90 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 16
Population: Intent-to-treat (ITT) population: all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A) | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) | 1.7 percentage of participants |
| Risankizumab 75 mg (Part A) | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) | 75.9 percentage of participants |
| Risankizumab 150 mg (Part A) | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) | 74.5 percentage of participants |
p-value: <0.00195% CI: [62.2, 85]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [60.6, 84.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A)
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. PASI100 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 16
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A) | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A) | 0 percentage of participants |
| Risankizumab 75 mg (Part A) | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A) | 22.4 percentage of participants |
| Risankizumab 150 mg (Part A) | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A) | 32.7 percentage of participants |
Comparison: Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.p-value: <0.00195% CI: [11.8, 33.4]Cochran-Mantel-Haenszel
Comparison: Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.p-value: <0.00195% CI: [20, 45]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A)
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. PASI75 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 16
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A) | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A) | 8.6 percentage of participants |
| Risankizumab 75 mg (Part A) | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A) | 89.7 percentage of participants |
| Risankizumab 150 mg (Part A) | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A) | 94.5 percentage of participants |
Comparison: Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.p-value: <0.00195% CI: [70.1, 90.4]Cochran-Mantel-Haenszel
Comparison: Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.p-value: <0.00195% CI: [76.8, 95.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) 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. Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 16
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A) | Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) | 10.3 percentage of participants |
| Risankizumab 75 mg (Part A) | Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) | 86.2 percentage of participants |
| Risankizumab 150 mg (Part A) | Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) | 92.7 percentage of participants |
Comparison: Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.p-value: <0.00195% CI: [63.8, 86.2]Cochran-Mantel-Haenszel
Comparison: Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.p-value: <0.00195% CI: [72.2, 92.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving PASI100 at Week 52 (Part B)
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. PASI100 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 52
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A) | Percentage of Participants Achieving PASI100 at Week 52 (Part B) | 40.7 percentage of participants |
| Risankizumab 75 mg (Part A) | Percentage of Participants Achieving PASI100 at Week 52 (Part B) | 44.4 percentage of participants |
| Risankizumab 150 mg (Part A) | Percentage of Participants Achieving PASI100 at Week 52 (Part B) | 43.1 percentage of participants |
| Risankizumab150 mg /Risankizumab 150 mg (Part B) | Percentage of Participants Achieving PASI100 at Week 52 (Part B) | 41.8 percentage of participants |
Secondary
Percentage of Participants Achieving PASI75 at Week 52 (Part B)
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. PASI75 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 52
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A) | Percentage of Participants Achieving PASI75 at Week 52 (Part B) | 100 percentage of participants |
| Risankizumab 75 mg (Part A) | Percentage of Participants Achieving PASI75 at Week 52 (Part B) | 88.9 percentage of participants |
| Risankizumab 150 mg (Part A) | Percentage of Participants Achieving PASI75 at Week 52 (Part B) | 94.8 percentage of participants |
| Risankizumab150 mg /Risankizumab 150 mg (Part B) | Percentage of Participants Achieving PASI75 at Week 52 (Part B) | 96.4 percentage of participants |
Secondary
Percentage of Participants Achieving PASI90 at Week 52 (Part B)
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. PASI90 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 follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 52
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A) | Percentage of Participants Achieving PASI90 at Week 52 (Part B) | 81.5 percentage of participants |
| Risankizumab 75 mg (Part A) | Percentage of Participants Achieving PASI90 at Week 52 (Part B) | 85.2 percentage of participants |
| Risankizumab 150 mg (Part A) | Percentage of Participants Achieving PASI90 at Week 52 (Part B) | 86.2 percentage of participants |
| Risankizumab150 mg /Risankizumab 150 mg (Part B) | Percentage of Participants Achieving PASI90 at Week 52 (Part B) | 92.7 percentage of participants |
Secondary
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) 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. Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 52
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A) | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B) | 96.3 percentage of participants |
| Risankizumab 75 mg (Part A) | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B) | 88.9 percentage of participants |
| Risankizumab 150 mg (Part A) | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B) | 84.5 percentage of participants |
| Risankizumab150 mg /Risankizumab 150 mg (Part B) | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B) | 94.5 percentage of participants |
Secondary
Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B)
Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 52
Population: Among participants with confirmed diagnosis of PsA using CASPAR criteria and with baseline TJC and SJC counts ≥ 3 at selected study sites of the ITT population,
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A) | Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B) | 100 percentage of participants |
| Risankizumab 75 mg (Part A) | Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B) | 100 percentage of participants |
| Risankizumab 150 mg (Part A) | Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B) | 60.0 percentage of participants |
| Risankizumab150 mg /Risankizumab 150 mg (Part B) | Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B) | 0 percentage of participants |
Secondary
Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A)
Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
Time frame: Week 16
Population: Among participants with confirmed diagnosis of PsA using classification criteria for psoriatic arthritis (CASPAR) and with baseline total tender joint count (TJC) and swollen joint count (SJC) counts ≥ 3 at selected study sites of the ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A) | Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A) | 0 percentage of participants |
| Risankizumab 75 mg (Part A) | Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A) | 40.0 percentage of participants |
| Risankizumab 150 mg (Part A) | Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A) | 33.3 percentage of participants |
Comparison: Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.p-value: 0.13195% CI: [-11.6, 90.1]Cochran-Mantel-Haenszel
p-value: 0.26995% CI: [-24.2, 86.7]Cochran-Mantel-Haenszel