Trial Outcomes & Findings for High Dose Risankizumab for Psoriasis (NCT NCT05283135)
NCT ID: NCT05283135
Last Updated: 2025-10-24
Results Overview
The number of lesional CD8+ Trm1 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm1 cells were identified as IFNγ+/CD8+/CD69+ T cells.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
52 weeks
Results posted on
2025-10-24
Participant Flow
Participant milestones
| Measure |
600 mg Dose Group
Received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections. Subjects were followed through week 100, the first 52 weeks in a double-blind manner, then the next 48 weeks in an unblinded extension period.
|
300 mg Dose Group
Received risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16 and then no further injections. Subjects were followed through week 100, the first 52 weeks in a double-blind manner, then the next 48 weeks in an unblinded extension period.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
Completed Dosing (Week 16)
|
9
|
9
|
|
Overall Study
Completed 52 Week Blinded Period
|
8
|
8
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Dose Risankizumab for Psoriasis
Baseline characteristics by cohort
| Measure |
600 mg Dose Group
n=10 Participants
Received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections. Subjects were followed through week 100, the first 52 weeks in a double-blind manner, then the next 48 weeks in an unblinded extension period.
|
300 mg Dose Group
n=10 Participants
Received risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16 and then no further injections. Subjects were followed through week 100, the first 52 weeks in a double-blind manner, then the next 48 weeks in an unblinded extension period.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
46.8 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Psoriasis disease duration
|
26.0 years
STANDARD_DEVIATION 18.1 • n=5 Participants
|
16.9 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
21.4 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Weight
|
88.42 kg
STANDARD_DEVIATION 20.7 • n=5 Participants
|
86.7 kg
STANDARD_DEVIATION 13.7 • n=7 Participants
|
87.6 kg
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
sPGA
sPGA 3 (moderate)
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
sPGA
sPGA 4 (severe)
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Cell counts from all participants were analyzed together at baseline given the exploratory nature of this study, the small number of overall participants and the selection of trial participants on the basis of clinical parameters that assume a similar degree of memory cell infiltrate in lesional psoriasis plaques.
The number of lesional CD8+ Trm1 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm1 cells were identified as IFNγ+/CD8+/CD69+ T cells.
Outcome measures
| Measure |
600 mg Baseline
n=5 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
300 mg Baseline
n=8 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 300 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
600 mg Week 52
n=5 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
300 mg Week 52
n=8 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
|---|---|---|---|---|
|
CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52
|
9.60 number of cells
Interval -1.97 to 21.17
|
26.71 number of cells
Interval 7.0 to 46.43
|
1.60 number of cells
Interval 0.18 to 3.02
|
16.63 number of cells
Interval 0.15 to 33.1
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Cell counts from all participants were analyzed together at baseline given the exploratory nature of this study, the small number of overall participants and the selection of trial participants on the basis of clinical parameters that assume a similar degree of memory cell infiltrate in lesional psoriasis plaques.
The number of lesional CD8+ Trm17 cells at baseline and Week 52 was calculated by longitudinal single-cell RNA-sequencing of full-thickness skin biopsy samples. Uniform Manifold Approximation Projection (UMAP) was used for T cell subtype visualization and CD8+ Trm17 cells were identified as IFNγ+/CD8+/CD69+ T cells.
Outcome measures
| Measure |
600 mg Baseline
n=5 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
300 mg Baseline
n=8 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 300 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
600 mg Week 52
n=5 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
300 mg Week 52
n=8 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
|---|---|---|---|---|
|
CD8+ Trm17 Cells in Lesional Skin at Baseline and Week 52
|
19.67 number of cells
Interval -28.52 to 67.86
|
22.88 number of cells
Interval 5.94 to 39.81
|
3.20 number of cells
Interval -5.01 to 11.41
|
5.00 number of cells
Interval -1.0 to 11.0
|
SECONDARY outcome
Timeframe: Enrollment to Week 52Population: 18 total subjects completed all 3 risankizumab injections and were considered evaluable in efficacy assessments
The percentage of patients with Psoriasis Area and Severity Index (PASI) 100 (complete clearance) at Weeks 28, 40, and 52 in patients receiving 4X standard induction doses of risankizumab vs. those receiving 2X standard induction doses of risankizumab.
Outcome measures
| Measure |
600 mg Baseline
n=9 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
300 mg Baseline
n=9 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 300 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
600 mg Week 52
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
300 mg Week 52
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
|---|---|---|---|---|
|
PASI 100 Results in Patients Receiving 4X Standard Induction Doses of Risankizumab vs. Those Receiving 2X Standard Induction Doses of Risankizumab.
PASI 100 at week 28
|
7 Participants
|
8 Participants
|
—
|
—
|
|
PASI 100 Results in Patients Receiving 4X Standard Induction Doses of Risankizumab vs. Those Receiving 2X Standard Induction Doses of Risankizumab.
PASI 100 at week 40
|
6 Participants
|
6 Participants
|
—
|
—
|
|
PASI 100 Results in Patients Receiving 4X Standard Induction Doses of Risankizumab vs. Those Receiving 2X Standard Induction Doses of Risankizumab.
PASI 100 at week 52
|
4 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Enrollment to Week 52Population: Treatment emergent adverse events
Safety events over 52 weeks in patients receiving 4X standard induction doses of risankizumab vs. those receiving 2X standard induction doses of risankizumab.
Outcome measures
| Measure |
600 mg Baseline
n=10 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
300 mg Baseline
n=10 Participants
Lesional skin from those participants who received risankizumab subcutaneous injection 300 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
600 mg Week 52
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
300 mg Week 52
Lesional skin from those participants who received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections.
|
|---|---|---|---|---|
|
Safety Events
Serious TEAE related to study treatment
|
0 events
|
0 events
|
—
|
—
|
|
Safety Events
TEAE
|
11 events
|
11 events
|
—
|
—
|
|
Safety Events
TEAE related to study treatment
|
0 events
|
0 events
|
—
|
—
|
|
Safety Events
Serious or severe TEAE
|
0 events
|
1 events
|
—
|
—
|
Adverse Events
600 mg Dose Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
300 mg Dose Group
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
600 mg Dose Group
n=10 participants at risk
Received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections. Subjects were followed through week 100, the first 52 weeks in a double-blind manner, then the next 48 weeks in an unblinded extension period.
|
300 mg Dose Group
n=10 participants at risk
Received risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16 and then no further injections. Subjects were followed through week 100, the first 52 weeks in a double-blind manner, then the next 48 weeks in an unblinded extension period.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
worsening right tibial fracture and meniscal tear
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
Other adverse events
| Measure |
600 mg Dose Group
n=10 participants at risk
Received risankizumab subcutaneous injection 600 mg (4x dosing) at Weeks 0, 4, and 16 and then no further injections. Subjects were followed through week 100, the first 52 weeks in a double-blind manner, then the next 48 weeks in an unblinded extension period.
|
300 mg Dose Group
n=10 participants at risk
Received risankizumab subcutaneous injection 300 mg (2x dosing) at Weeks 0, 4, and 16 and then no further injections. Subjects were followed through week 100, the first 52 weeks in a double-blind manner, then the next 48 weeks in an unblinded extension period.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 infection
|
30.0%
3/10 • Number of events 3 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
30.0%
3/10 • Number of events 4 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Skin and subcutaneous tissue disorders
Eczematous dermatitis
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Gastrointestinal disorders
Bleeding internal hemorrhoids
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Musculoskeletal and connective tissue disorders
Bursitis, left elbow
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Musculoskeletal and connective tissue disorders
Worsening psoriatic arthritis
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Blood and lymphatic system disorders
Neutrophilia
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis, right hip
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Musculoskeletal and connective tissue disorders
Worsening osteoarthritis, right hip
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Infections and infestations
Cellulitis, left lower extremity
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Hepatobiliary disorders
Transaminitis
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Musculoskeletal and connective tissue disorders
Right tibial fracture and meniscal tear
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Musculoskeletal and connective tissue disorders
Left inguinal hernia
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 2 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Gastrointestinal disorders
Gastroenteritis
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Eye disorders
Worsening glaucoma
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
50.0%
5/10 • Number of events 5 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
20.0%
2/10 • Number of events 3 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
|
General disorders
Cough
|
0.00%
0/10 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
10.0%
1/10 • Number of events 1 • 100 weeks
AEs were collected from the time of consent at all subject visits
|
Additional Information
Benjamin Ehst, MD, PhD
Oregon Medical Research Center, PC
Phone: 5032451525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place