Psoriasis
Conditions
Keywords
ABBV-066, BI 655066, risankizumab
Brief summary
This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis.
Detailed description
In Part A1, eligible participants were randomized at Baseline at a ratio of 4:1, stratified by weight and prior exposure to tumor necrosis factor antagonists to receive double-blind (DB) risankizumab 150 mg or placebo at Weeks 0 and 4. In Part A2, participants randomized at Baseline to receive DB placebo then received risankizumab 150 mg at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B); participants randomized to risankizumab 150 mg continued to receive risankizumab 150 mg at Week 16. Participants who received risankizumab in Part A and were nonresponders (sPGA \>2) at Week 28 received risankizumab 150 mg at Week 28 and every 12 weeks up to 88 weeks (Part B). In Part B, participants who received risankizumab in Part A and were responders (sPGA ≤2) at Week 28, were rerandomized at a ratio of 1:2 to receive DB risankizumab 150 mg or placebo at Week 28 and every 12 weeks up to 88 weeks (Part B). Starting at Week 32, rerandomized participants who reached relapse (defined as sPGA ≥3) were switched to risankizumab 150 mg every 12 weeks.
Interventions
DRUGRisankizumab
Risankizumab administered by subcutaneous injection
DRUGPlacebo
Placebo for risankizumab administered by subcutaneous injection
Sponsors
Boehringer Ingelheim
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
* Male or female participants. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly. * Age ≥18 years at screening * Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the participant. * Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization); Have an involved body surface area (BSA) ≥ 10% and Have a Psoriasis Area and Severity Index (PASI) ≥ 12 and Have a static Physician Global Assessment (sPGA) score of ≥ 3. * Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator * Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion criteria
* Participants with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to the investigators judgment. * Previous exposure to ABBV-066 * Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study * Use of any restricted medication as noted or any drug considered likely to interfere with the safe conduct of the study. * Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement, removal aneurysm, stomach ligation). * Known chronic or relevant acute infections such as active tuberculosis, human immunodeficiency virus (HIV), or viral hepatitis * Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix * Evidence of a current or previous disease (including chronic alcohol or drug abuse), medical condition other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram \[ECG\]), or laboratory value at the screening visit outside the reference range that in the opinion of the Investigator, is clinically significant and would make the study participant unable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data. * History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients * Women who are pregnant, nursing, or who plan to become pregnant while in the trial * Previous enrolment in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 | Baseline, 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. Non-responder imputation (NRI) was used for missing data. |
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | 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. NRI was used for missing data. |
| Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 | 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. NRI was used for missing data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | Week 16 | The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. NRI was used for missing data. |
| Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104 | Week 104 | 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. NRI was used for missing data. |
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | 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. NRI was used for missing data. |
| Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52 | 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. NRI was used for missing data. |
| Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52 | 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. NRI was used for missing data. |
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52 | 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. NRI was used for missing data. |
| Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 | 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. NRI was used for missing data. |
| Percentage of Participants Achieving an sPGA Score of Clear at Week 16 | 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. NRI was used for missing data. |
Participant flow
Pre-assignment details
Part A1: double-blind (DB) risankizumab or placebo (Weeks 0,4). Part A2 (Week 16) DB placebo to DB risankizumab; risankizumab continued risankizumab. Part B (Week 28) risankizumab responders rerandomized to DB risankizumab/placebo; risankizumab nonresponders continued risankizumab. Week 32: rerandomized relapsed switch risankizumab.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Part A1) Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1). | 100 |
| Risankizumab (Part A1) Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1). | 407 |
| Total | 507 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Part A1 | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part A1 | Disease Worsening | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A1 | Lost to Follow-up | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Part A1 | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part A2 | Adverse Event | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
| Part A2 | Disease worsening | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Part A2 | Lost to Follow-up | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Part A2 | Not entered in Part B | 0 | 0 | 0 | 4 | 0 | 0 | 0 |
| Part A2 | Other | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
| Part A2 | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Part B | Disease worsening | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Part B | Lost to Follow-up | 0 | 0 | 0 | 0 | 3 | 4 | 1 |
| Part B | Other | 0 | 0 | 0 | 0 | 4 | 1 | 2 |
| Part B | Other adverse event | 0 | 0 | 0 | 0 | 3 | 5 | 1 |
| Part B | Withdrawal by Subject | 0 | 0 | 0 | 0 | 5 | 0 | 7 |
| Part B | Worsening pre-existing condition | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Risankizumab (Part A1) | Total | Placebo (Part A1) |
|---|---|---|---|
| Age, Continuous | 49.6 years STANDARD_DEVIATION 13.17 | 49.2 years STANDARD_DEVIATION 13.3 | 47.9 years STANDARD_DEVIATION 13.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 56 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 362 Participants | 451 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 64 Participants | 79 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 20 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 320 Participants | 402 Participants | 82 Participants |
| Sex: Female, Male Female | 124 Participants | 151 Participants | 27 Participants |
| Sex: Female, Male Male | 283 Participants | 356 Participants | 73 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 407 | 0 / 225 | 2 / 111 | 4 / 500 |
| other Total, other adverse events | 17 / 100 | 52 / 407 | 92 / 225 | 52 / 111 | 242 / 500 |
| serious Total, serious adverse events | 8 / 100 | 8 / 407 | 17 / 225 | 13 / 111 | 55 / 500 |
Outcome results
Primary
Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to 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. Non-responder imputation (NRI) was used for missing data.
Time frame: Baseline, Week 16
Population: Intent to treat (ITT) Population in Part A1(ITT\_A1): all participants who were randomized at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 | 2.0 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 | 73.2 percentage of participants |
Comparison: Across strata, P value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [65.7, 76]Cochran-Mantel-Haenszel
Primary
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at 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. NRI was used for missing data.
Time frame: Week 52
Population: ITT Population in Part B for re-randomized participants (ITT\_B\_R): All participants who were randomized to Arm 1 at Baseline and re randomized at Week 28.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 | 61.3 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 | 87.4 percentage of participants |
Comparison: Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [17.3, 34.6]Cochran-Mantel-Haenszel
Primary
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score 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 (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. NRI was used for missing data.
Time frame: Week 16
Population: ITT Population in Part A1(ITT\_A1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | 7.0 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | 83.5 percentage of participants |
Comparison: Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [70.4, 82.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at 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. NRI was used for missing data.
Time frame: Week 16
Population: ITT Population in Part A1 (ITT\_A1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 | 1.0 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 | 47.2 percentage of participants |
Comparison: Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [40.3, 50.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at 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. NRI was used for missing data.
Time frame: Week 52
Population: ITT Population in Part B for re-randomized participants (ITT\_B\_R)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52 | 30.2 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52 | 64.0 percentage of participants |
Comparison: Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [23.2, 44.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at 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. NRI was used for missing data.
Time frame: Week 16
Population: ITT Population in Part A1 (ITT\_A1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | 8.0 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | 88.7 percentage of participants |
Comparison: Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [74.5, 86.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at 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. NRI was used for missing data.
Time frame: Week 52
Population: ITT Population in Part B for re-randomized participants (ITT\_B\_R)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52 | 71.6 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52 | 92.8 percentage of participants |
Comparison: Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [13.7, 28.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at 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. NRI was used for missing data.
Time frame: Week 52
Population: ITT Population in Part B for re-randomized participants (ITT\_B\_R)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52 | 52.4 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52 | 85.6 percentage of participants |
Comparison: Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [24, 42.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. NRI was used for missing data.
Time frame: Week 16
Population: ITT Population in Part A1 (ITT\_A1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | 3.0 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | 65.4 percentage of participants |
Comparison: Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [56.4, 67.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving an sPGA Score of Clear at 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. NRI was used for missing data.
Time frame: Week 16
Population: ITT Population in Part A1 (ITT\_A1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving an sPGA Score of Clear at Week 16 | 1.0 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving an sPGA Score of Clear at Week 16 | 46.4 percentage of participants |
Comparison: Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [39.5, 50]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104
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. NRI was used for missing data.
Time frame: Week 104
Population: ITT Population in Part B for re-randomized participants (ITT\_B\_R)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Part A1) | Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104 | 7.1 percentage of participants |
| Risankizumab (Part A1) | Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104 | 81.1 percentage of participants |
Comparison: Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).p-value: <0.00195% CI: [66, 81.9]Cochran-Mantel-Haenszel