Psoriasis Vulgaris
Conditions
Brief summary
This study examines the effect of IL-23 blockade with Tildrakizumab on the immune cells of psoriatic skin lesions.
Detailed description
This is a one-arm, open-label study to examine the effect of Tildrakizumab. Tildrakizumab is a FDA-approved medication for the treatment of cutaneous psoriasis. This study will examine how Tildrakizumab affects immune cells within psoriatic skin lesions. Fifteen subjects with moderate to severe psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict Tildrakizumab treatment response.
Interventions
BIOLOGICALTildrakizumab
IL-23 inhibitor
Sponsors
Sun Pharmaceutical Industries Limited
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥18 years of age at clinic visit. * Documentation of moderate-severe psoriasis or atypical psoriasis. * Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Exclusion criteria
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data * Tuberculosis, active serious infection, active systemic malignancy, * Received a systemic medication for psoriasis within 3 months of study screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) Score | baseline and 3 months | Psoriasis Area and Severity Index (PASI) is a measure of psoriasis severity. The maximum score is 72, minimum score is 0. The higher the number, the more severe the psoriasis is. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tildrakizumab Treatment Tildrakizumab: IL-23 inhibitor | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Tildrakizumab Treatment | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Age, Continuous | 37 years | — |
| Psoriasis Area and Severity Index (PASI) Score | 10.7 units on a scale STANDARD_DEVIATION 3.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 7 Participants | — |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Psoriasis Area and Severity Index (PASI) Score
Psoriasis Area and Severity Index (PASI) is a measure of psoriasis severity. The maximum score is 72, minimum score is 0. The higher the number, the more severe the psoriasis is.
Time frame: baseline and 3 months
Population: treated patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tildrakizumab Treatment | Psoriasis Area and Severity Index (PASI) Score | 3.9 score on a scale | Standard Deviation 4.1 |