Psoriasis
Conditions
Keywords
Psoriasis, Skin Diseases, Skin Diseases, Papulosquamous, Adalimumab, Anti-Inflammatory Agents, ABBV-066, BI 655066, Risankizumab
Brief summary
This is a randomized double blind, double dummy, active comparator controlled, parallel design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) compared to adalimumab to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.
Detailed description
This study consists of 2 parts (Part A and Part B). Part A: * Participants were randomized to receive either risankizumab or adalimumab. Part B: * Participants who received risankizumab in Part A continued to receive risankizumab in Part B * Adalimumab nonresponders (\<PASI 50 at Week 16) switched to risankizumab in Part B; * Adalimumab responders (PASI 90 at Week 16) continued to received adalimumab in Part B; * Adalimumab inadequate responders (PASI 50 to \<PASI 90) were rerandomized to receive either risankizumab or adalimumab in Part B.
Interventions
DRUGrisankizumab
Risankizumab administered by subcutaneous (SC) injection
BIOLOGICALadalimumab
Adalimumab pre-filled syringe, administered by subcutaneous (SC) injection
Placebo risankizumab administered by subcutaneous (SC) injection
BIOLOGICALplacebo for adalimumab
Placebo for adalimumab 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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients. Women of childbearing potential\* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. \*Women of childbearing potential are defined as: * having experienced menarche and * not postmenopausal (12 months with no menses without an alternative medical cause) and * not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy). * Age ≥ 18 years at screening * 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 (Randomization): * Have an involved body surface area (BSA) ≥ 10% and * Have a Psoriasis Area and Severity Index (PASI) score ≥ 12 and * Have a static Physician Global Assessment (sPGA) score of ≥ 3. * Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator * Must be candidates for treatment with adalimumab (Humira®) according to local label as confirmed by the investigator. * Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria
* Patients with * non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular) * current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigator's judgment * Previous exposure to ABBV-066 * Previous exposure to adalimumab (Humira®) * Currently enrolled in another investigational study or less than 30 days or more from screening since completing another investigational drug or device study. * Use of any restricted medication 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 (TB), human immunodeficiency virus (HIV) or viral hepatitis; QuantiFERON® TB test or purified protein derivative (PPD) skin test will be performed according to local labelling for Humira®. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active TB. If presence of latent TB is established, then treatment should have been initiated and maintained according to local country guidelines. * Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix. * Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) 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 unreliable 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 Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) | Week 44 | 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 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. |
| Percentage of Participants Achieving 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. NRI was used for missing data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B) | Week 44 | 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 Who Were ReRandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear at Week 44 (Part B) | Week 44 | 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 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. NRI was used for missing data. |
| Percentage of Participants Achieving 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. NRI was used for missing data. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear or Almost Clear at Week 44 (Part B) | Week 44 | 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
A total of 684 subjects were enrolled; 79 subjects failed screening and are excluded from the analyses.
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab (Part A) Participants randomized to receive double blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Weeks 0, 1, and every other week for 15 weeks (Part A). | 304 |
| Risankizumab (Part A) Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4 (Part A). | 301 |
| Total | 605 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Part A | Adverse Event | 7 | 3 | 0 | 0 | 0 | 0 | 0 |
| Part A | Lost to Follow-up | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Part A | Other | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part A | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A | Withdrawal by Subject | 3 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part B | Adverse Event | 0 | 0 | 7 | 1 | 1 | 2 | 0 |
| Part B | Lost to Follow-up | 0 | 0 | 2 | 3 | 2 | 0 | 1 |
| Part B | Other | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Part B | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Part B | Withdrawal by Subject | 0 | 0 | 9 | 0 | 1 | 3 | 0 |
Baseline characteristics
| Characteristic | Risankizumab (Part A) | Total | Adalimumab (Part A) |
|---|---|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 13.79 | 46.2 years STANDARD_DEVIATION 13.46 | 47.0 years STANDARD_DEVIATION 13.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants | 103 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 257 Participants | 502 Participants | 245 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 41 Participants | 76 Participants | 35 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 17 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 245 Participants | 508 Participants | 263 Participants |
| Sex: Female, Male Female | 91 Participants | 183 Participants | 92 Participants |
| Sex: Female, Male Male | 210 Participants | 422 Participants | 212 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 304 | 1 / 301 | 0 / 294 | 0 / 38 | 0 / 56 | 0 / 53 |
| other Total, other adverse events | 71 / 304 | 76 / 301 | 95 / 294 | 16 / 38 | 21 / 56 | 24 / 53 |
| serious Total, serious adverse events | 9 / 304 | 10 / 301 | 12 / 294 | 4 / 38 | 2 / 56 | 3 / 53 |
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 population in Part A (ITT\_A): All subjects randomized at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab (Part A) | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) | 47.4 percentage of participants |
| Risankizumab (Part A) | Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) | 72.4 percentage of participants |
Comparison: P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to tumor necrosis factor (TNF) antagonists (0 vs ≥1).p-value: <0.00195% CI: [17.5, 32.4]Cochran-Mantel-Haenszel
Primary
Percentage of Participants Achieving 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. NRI was used for missing data.
Time frame: Week 16
Population: ITT\_A population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab (Part A) | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) | 60.2 percentage of participants |
| Risankizumab (Part A) | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) | 83.7 percentage of participants |
Comparison: P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).p-value: <0.00195% CI: [16.6, 30.1]Cochran-Mantel-Haenszel
Primary
Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (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. NRI was used for missing data.
Time frame: Week 44
Population: Intent-to-treat population in Part B who were re-randomized (ITT\_B\_RR): All subjects who started with adalimumab at Baseline and were re-randomized at Week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab (Part A) | Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) | 21.4 percentage of participants |
| Risankizumab (Part A) | Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) | 66.0 percentage of participants |
Comparison: P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).p-value: <0.00195% CI: [28.9, 61.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 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. NRI was used for missing data.
Time frame: Week 16
Population: ITT\_A population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab (Part A) | Percentage of Participants Achieving PASI100 at Week 16 (Part A) | 23.0 percentage of participants |
| Risankizumab (Part A) | Percentage of Participants Achieving PASI100 at Week 16 (Part A) | 39.9 percentage of participants |
Comparison: P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).p-value: <0.00195% CI: [9.5, 23.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving 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. NRI was used for missing data.
Time frame: Week 16
Population: ITT\_A population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab (Part A) | Percentage of Participants Achieving PASI75 at Week 16 (Part A) | 71.7 percentage of participants |
| Risankizumab (Part A) | Percentage of Participants Achieving PASI75 at Week 16 (Part A) | 90.7 percentage of participants |
Comparison: P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).p-value: <0.00195% CI: [13, 24.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (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. NRI was used for missing data.
Time frame: Week 44
Population: ITT\_B\_RR population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab (Part A) | Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B) | 7.1 percentage of participants |
| Risankizumab (Part A) | Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B) | 39.6 percentage of participants |
Comparison: P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).p-value: <0.00195% CI: [18.8, 46.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Were ReRandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear at Week 44 (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. NRI was used for missing data.
Time frame: Week 44
Population: ITT\_B\_RR population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab (Part A) | Percentage of Participants Who Were ReRandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear at Week 44 (Part B) | 7.1 percentage of participants |
| Risankizumab (Part A) | Percentage of Participants Who Were ReRandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear at Week 44 (Part B) | 39.6 percentage of participants |
Comparison: P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).p-value: <0.00195% CI: [18.8, 46.9]Cochran-Mantel-Haenszel
Other Pre-specified
Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear or Almost Clear at Week 44 (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. NRI was used for missing data.
Time frame: Week 44
Population: ITT\_B\_RR population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab (Part A) | Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear or Almost Clear at Week 44 (Part B) | 33.9 percentage of participants |
| Risankizumab (Part A) | Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear or Almost Clear at Week 44 (Part B) | 73.6 percentage of participants |
Comparison: P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).p-value: <0.00195% CI: [22, 55.8]Cochran-Mantel-Haenszel