Trial Outcomes & Findings for Brain Changes in Psoriasis After Secukinumab Treatment (NCT NCT04717466)
NCT ID: NCT04717466
Last Updated: 2025-06-05
Results Overview
Change in brain anatomy for participants will be reported as the change in average gray matter density as measured by Voxel Based Morphometry (VBM) analysis of Magnetic Resonance Imaging (MRI) scans from baseline to week 4
COMPLETED
PHASE4
20 participants
Baseline to Week 4 (Visit 3)
2025-06-05
Participant Flow
Participant milestones
| Measure |
Psoriasis Group
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Changes in Psoriasis After Secukinumab Treatment
Baseline characteristics by cohort
| Measure |
Psoriasis Group
n=10 Participants
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
n=10 Participants
Healthy participants will not receive any intervention.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4 (Visit 3)Change in brain anatomy for participants will be reported as the change in average gray matter density as measured by Voxel Based Morphometry (VBM) analysis of Magnetic Resonance Imaging (MRI) scans from baseline to week 4
Outcome measures
| Measure |
Psoriasis Group
n=10 Participants
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
n=10 Participants
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Change in Gray Matter Density
|
0 voxel
Standard Deviation 0
|
0 voxel
Standard Deviation 0.000927413
|
PRIMARY outcome
Timeframe: Baseline to Week 4 (Visit 3)Changes in brain activity in participants will be measured using Arterial Spin Labeling (ASL) MRI from baseline to week 4. ASL quantifies cerebral blood flow CBF in units of ml/100g/min (milliliters of blood per 100 grams of tissue per minute).
Outcome measures
| Measure |
Psoriasis Group
n=10 Participants
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
n=10 Participants
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Change in Brain Activity
|
1 ml/100g/min
Standard Deviation 55.79089921
|
-18 ml/100g/min
Standard Deviation 87.98956788
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (Visit 3)Population: Only psoriasis patient group included for this analysis as healthy controls were required by enrollment criteria to not have itch.
Itch will be measured using the Numerical Rating Scaling (NRS) ranging from 0 (no itch) to 10 (the worst itch imaginable) baseline to week 4 in psoriasis participant group only.
Outcome measures
| Measure |
Psoriasis Group
n=10 Participants
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Change in Itch Score as Measured by the NRS
|
3 units on a scale
Standard Deviation 0.130835626
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (Visit 3)Population: Only psoriasis patient group included for this analysis as healthy controls were required by enrollment criteria to not have pain.
Pain will be measured using a Numerical Rating Scaling (NRS) ranging from 0 (no pain) to 10 (the worst pain imaginable) baseline to week 4 in psoriasis participant group only.
Outcome measures
| Measure |
Psoriasis Group
n=10 Participants
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Change in Pain Score as Measured by the NRS
|
2 units on a scale
Standard Error 0.186739941
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (Visit 3)Population: Only psoriasis patient group included for this analysis as healthy controls were required by enrollment criteria to not have psoriasis.
Severity of psoriasis will be measured using the Psoriasis Area and Severity Index (PASI), ranging from 0 to 100 with a higher score indicating more severe psoriasis, from baseline to week 4 in psoriasis participant group only.
Outcome measures
| Measure |
Psoriasis Group
n=10 Participants
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Change in PASI Scores
|
8 score on a scale
Standard Deviation 8.206099453
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (Visit 3)Well-being will be measured using the 5-item World Health Organization Well-Being Index (WHO-5), ranging from 0 to 25 with a higher score indicating better well-being, from baseline to week 4.
Outcome measures
| Measure |
Psoriasis Group
n=10 Participants
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
n=10 Participants
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Change in Participant Well-being as Measured by WHO-5
|
2 units on a scale
Standard Deviation 0.59336165
|
0 units on a scale
Standard Deviation 0.382739698
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (Visit 3)Population: Initial protocol was to use PSQI survey, but after PI could not get rights for survey use, the protocol was amended to collect sleep disturbance on an NRS scale. Not all study participates completed the Sleep NRS survey, so data was reported on those that did complete this NRS once protocol amendment for its use was IRB approved.
Changes in participants' quality of sleep by using the Numerical Rating Scaling (NRS) ranging from 0 to 10, with a higher score indicating lower sleep quality between baseline, from baseline to week 4.
Outcome measures
| Measure |
Psoriasis Group
n=5 Participants
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
n=7 Participants
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Change in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores
|
0 score on a scale
Standard Deviation 0.5
|
2 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (Visit 3)Physical activity will be measured using the 7-days physical activity recall (7D-PAR), with 0 denoting no exercise and a higher score indicating more physical activity (there is not cap for this score), from baseline to week 4.
Outcome measures
| Measure |
Psoriasis Group
n=10 Participants
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
n=10 Participants
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Change in Physical Activity as Measured by 7D-PAR
|
7 score on a scale
Standard Deviation 9.892384903
|
9 score on a scale
Standard Deviation 0.451011454
|
SECONDARY outcome
Timeframe: Baseline, Up to Week 4 (Visit 3)Stress in daily life in psoriasis participants will be measured using the Perceived Stress Questionnaire (PSQ), ranging from 0 to 1 with a higher score indicating more stress, from baseline to week 4.
Outcome measures
| Measure |
Psoriasis Group
n=10 Participants
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
n=10 Participants
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Changes in Stress in Daily Life as Measured by PSQ
|
0.07 score on a scale
Standard Deviation 0
|
0.01 score on a scale
Standard Deviation 0.01
|
Adverse Events
Psoriasis Group
Healthy Group
Serious adverse events
| Measure |
Psoriasis Group
n=10 participants at risk
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
n=10 participants at risk
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Infected Abcess
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
Other adverse events
| Measure |
Psoriasis Group
n=10 participants at risk
Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
Secukinumab: 300mg subcutaneous injection
|
Healthy Group
n=10 participants at risk
Healthy participants will not receive any intervention.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
itch
|
20.0%
2/10 • Number of events 2 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Felt cramped
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Skin and subcutaneous tissue disorders
Bruising
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Skin and subcutaneous tissue disorders
Swelling
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal and chest congestions
|
0.00%
0/10 • 4 months
|
10.0%
1/10 • Number of events 1 • 4 months
|
|
General disorders
tiredness
|
10.0%
1/10 • Number of events 2 • 4 months
|
0.00%
0/10 • 4 months
|
|
Nervous system disorders
headache
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
|
Skin and subcutaneous tissue disorders
skin with red/raised/itch
|
10.0%
1/10 • Number of events 1 • 4 months
|
0.00%
0/10 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place