Trial Outcomes & Findings for Guselkumab Immunogenetics (NCT NCT04645355)
NCT ID: NCT04645355
Last Updated: 2026-06-23
Results Overview
Mean change from baseline in percent of lesional CD4+ T effector cells producing IL-17 between baseline and week 12
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
baseline and week 12
Results posted on
2026-06-23
Participant Flow
We recruited by recontact participants from prior studies who had previously consented, used referrals from colleagues with approved language, flyers, and directly from clinic. Recruitment ran from February 2021 until May 2023
Actual enrollment of a total of 17 patients, as detailed in the periods section. 3 additional screened but not enrolled as not eligible.
Participant milestones
| Measure |
New-onset Guttate Psoriasis
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
|
Chronic Plaque Psoriasis
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Guselkumab Immunogenetics
Baseline characteristics by cohort
| Measure |
New-onset Guttate Psoriasis
n=7 Participants
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
|
Chronic Plaque Psoriasis
n=10 Participants
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5714 years
STANDARD_DEVIATION 13.9864 • n=20 Participants
|
45.3 years
STANDARD_DEVIATION 8.47283 • n=20 Participants
|
41.29412 years
STANDARD_DEVIATION 11.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Lesional CD4+ effector cells
|
41.1 Percentage of IL17+ CD4 T cells
STANDARD_DEVIATION 4.3 • n=20 Participants
|
31.8 Percentage of IL17+ CD4 T cells
STANDARD_DEVIATION 10.2 • n=20 Participants
|
36.5 Percentage of IL17+ CD4 T cells
STANDARD_DEVIATION 13.2 • n=40 Participants
|
|
Lesional CD8+ T effector cells
|
14.5 Percentage of IL17+ CD8 T cells
STANDARD_DEVIATION 9.4 • n=20 Participants
|
7.9 Percentage of IL17+ CD8 T cells
STANDARD_DEVIATION 4.3 • n=20 Participants
|
11.5 Percentage of IL17+ CD8 T cells
STANDARD_DEVIATION 7.9 • n=40 Participants
|
PRIMARY outcome
Timeframe: baseline and week 12Mean change from baseline in percent of lesional CD4+ T effector cells producing IL-17 between baseline and week 12
Outcome measures
| Measure |
New-onset Guttate Psoriasis
n=7 Participants
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
|
Chronic Plaque Psoriasis
n=10 Participants
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
|
|---|---|---|
|
Lesional CD4+ T Effector Cells
|
-5.7 Absolute change in % of Th17 cells
Standard Deviation 13.5
|
0.9 Absolute change in % of Th17 cells
Standard Deviation 23.4
|
PRIMARY outcome
Timeframe: baseline and week 12Mean change from baseline in percent of lesional CD8+ T effector cells producing IL-17 between baseline and week 12
Outcome measures
| Measure |
New-onset Guttate Psoriasis
n=7 Participants
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
|
Chronic Plaque Psoriasis
n=10 Participants
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
|
|---|---|---|
|
Lesional CD8+ T Effector Cells
|
9.1 Absolute change in % of Th17 cells
Standard Deviation 17.2
|
12.5 Absolute change in % of Th17 cells
Standard Deviation 12.9
|
Adverse Events
New-onset Guttate Psoriasis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Chronic Plaque Psoriasis
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
New-onset Guttate Psoriasis
n=7 participants at risk
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
|
Chronic Plaque Psoriasis
n=10 participants at risk
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • From enrollment until complete of study, ie 96 weeks
|
10.0%
1/10 • From enrollment until complete of study, ie 96 weeks
|
|
Skin and subcutaneous tissue disorders
Lower extremity blisters
|
0.00%
0/7 • From enrollment until complete of study, ie 96 weeks
|
10.0%
1/10 • From enrollment until complete of study, ie 96 weeks
|
|
Injury, poisoning and procedural complications
Needle stick
|
14.3%
1/7 • From enrollment until complete of study, ie 96 weeks
|
0.00%
0/10 • From enrollment until complete of study, ie 96 weeks
|
Additional Information
Amelie Spangenberg and Wilson Liao
UCSF
Phone: 4107392678
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place