Trial Outcomes & Findings for A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis (NCT NCT03875482)
NCT ID: NCT03875482
Last Updated: 2021-03-16
Results Overview
The Psoriasis Area and Severity Index (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 Week 16) / PASI score at Baseline \* 100.
COMPLETED
PHASE3
157 participants
At Week 16
2021-03-16
Participant Flow
Intent-to-treat (ITT) population: all randomized participants
Participant milestones
| Measure |
Risankizumab
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
|
Placebo
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
52
|
|
Overall Study
COMPLETED
|
92
|
32
|
|
Overall Study
NOT COMPLETED
|
13
|
20
|
Reasons for withdrawal
| Measure |
Risankizumab
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
|
Placebo
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrew consent
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
8
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
11
|
Baseline Characteristics
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Risankizumab
n=105 Participants
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
|
Placebo
n=52 Participants
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 15.14 • n=5 Participants
|
48.8 years
STANDARD_DEVIATION 15.47 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 15.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
87 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Prior Use of Systemic Biologic for Psoriasis
0
|
58 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Prior Use of Systemic Biologic for Psoriasis
≥1
|
47 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Static Physician Global Assessment (sPGA) Score at Baseline
Score of 3
|
86 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Static Physician Global Assessment (sPGA) Score at Baseline
Score of 4
|
19 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) Score at Baseline
|
21.529 units on a scale
STANDARD_DEVIATION 9.5975 • n=5 Participants
|
21.060 units on a scale
STANDARD_DEVIATION 10.2563 • n=7 Participants
|
21.373 units on a scale
STANDARD_DEVIATION 9.7901 • n=5 Participants
|
|
Body Surface Area (BSA) Psoriasis Involvement at Baseline
|
28.343 Percentage of body surface area affected
STANDARD_DEVIATION 16.4139 • n=5 Participants
|
28.160 Percentage of body surface area affected
STANDARD_DEVIATION 18.4868 • n=7 Participants
|
28.282 Percentage of body surface area affected
STANDARD_DEVIATION 17.0689 • n=5 Participants
|
|
Duration of Plaque Psoriasis
|
20.91 years
STANDARD_DEVIATION 13.837 • n=5 Participants
|
15.82 years
STANDARD_DEVIATION 11.753 • n=7 Participants
|
19.22 years
STANDARD_DEVIATION 13.363 • n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 16Population: Intent-to-treat (ITT) population: all randomized participants; those with missing data were imputed as non-responders
The Psoriasis Area and Severity Index (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 Week 16) / PASI score at Baseline \* 100.
Outcome measures
| Measure |
Risankizumab
n=105 Participants
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
|
Placebo
n=52 Participants
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
|
|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
|
62.9 percentage of participants
Interval 53.6 to 72.1
|
3.8 percentage of participants
Interval 0.0 to 9.1
|
PRIMARY outcome
Timeframe: At Week 16Population: Intent-to-treat (ITT) population: all randomized participants; those with missing data were imputed as non-responders
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions 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.
Outcome measures
| Measure |
Risankizumab
n=105 Participants
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
|
Placebo
n=52 Participants
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
|
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16
|
78.1 percentage of participants
Interval 70.2 to 86.0
|
9.6 percentage of participants
Interval 1.6 to 17.6
|
SECONDARY outcome
Timeframe: At Week 16Population: Intent-to-treat (ITT) population: all randomized participants; those with missing data were imputed as non-responders
The Psoriasis Area and Severity Index (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 Week 16) / PASI score at Baseline \* 100.
Outcome measures
| Measure |
Risankizumab
n=105 Participants
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
|
Placebo
n=52 Participants
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
|
|---|---|---|
|
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16
|
38.1 percentage of participants
Interval 28.8 to 47.4
|
1.9 percentage of participants
Interval 0.0 to 5.7
|
SECONDARY outcome
Timeframe: At Week 16Population: Intent-to-treat (ITT) population: all randomized participants; those with missing data were imputed as non-responders
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions 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.
Outcome measures
| Measure |
Risankizumab
n=105 Participants
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
|
Placebo
n=52 Participants
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
|
|---|---|---|
|
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16
|
39.0 percentage of participants
Interval 29.7 to 48.4
|
1.9 percentage of participants
Interval 0.0 to 5.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, and Week 16Population: Intent-to-treat (ITT) population: all randomized participants with a non-missing baseline measurement and at least one post-baseline value
The Psoriasis Area and Severity Index (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. Negative values indicate an improvement from baseline.
Outcome measures
| Measure |
Risankizumab
n=101 Participants
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
|
Placebo
n=50 Participants
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
|
|---|---|---|
|
Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16
Week 4
|
-50.62 percent change from Baseline
Interval -56.255 to -44.987
|
-14.48 percent change from Baseline
Interval -22.49 to -6.47
|
|
Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score up to Week 16
Week 16
|
-89.36 percent change from Baseline
Interval -95.2 to -83.522
|
-29.39 percent change from Baseline
Interval -38.152 to -20.63
|
Adverse Events
Risankizumab
Placebo
Serious adverse events
| Measure |
Risankizumab
n=105 participants at risk
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
|
Placebo
n=52 participants at risk
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
|
|---|---|---|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed, up to 48 weeks. In addition, serious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/52 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed, up to 48 weeks. In addition, serious adverse events were collected from the time the participant signed the study-specific informed consent.
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study is administered until 20 weeks have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER