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CompletedNCT04541329Updated Apr 30, 2024Results posted

Predicting Inflammatory Skin Disease Response to IL-23 Blockade

A Phase 4 interventional study of Tildrakizumab in Psoriasis Vulgaris, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by University of California, San Francisco · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

This study examines the effect of IL-23 blockade with Tildrakizumab on the immune cells of psoriatic skin lesions.

Read the 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.

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Conditions studied

  • Psoriasis Vulgaris
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In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 7 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Tildrakizumab treatment

    Biological: Tildrakizumab

Interventions

  • BiologicalTildrakizumab

    IL-23 inhibitor

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What researchers measure

Primary outcomes

  1. 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

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Results

Posted Apr 30, 2024

Participant flow

Participant flow — Overall Study
MilestoneTildrakizumab Treatment
Started7
Completed7
Not completed0

Outcome measures

PrimaryPsoriasis 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
Reported as:
Mean · score on a scale
Psoriasis Area and Severity Index (PASI) Score
score on a scaleTildrakizumab Treatment
Psoriasis Area and Severity Index (PASI) Score3.9 ± 4.1

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tildrakizumab Treatment0/7 (0%)0/7 (0%)0/7 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Tildrakizumab Treatment
<=18 years0
Between 18 and 65 years7
>=65 years0
Age, Continuous
Age, Continuous(years)Tildrakizumab Treatment
Mean37 (30 to 46)
Sex: Female, Male
Sex: Female, Male(Participants)Tildrakizumab Treatment
Female3
Male4
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Tildrakizumab Treatment
Region of Enrollment
Region of Enrollment(Participants)Tildrakizumab Treatment
United States7
Psoriasis Area and Severity Index (PASI) Score
Psoriasis Area and Severity Index (PASI) Score(units on a scale)Tildrakizumab Treatment
Mean10.7 ± 3.6
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Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94158, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 24, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04541329
Lead sponsor
University of California, San Francisco
Collaborators
Sun Pharmaceutical Industries Limited
Responsible party
Sponsor
First posted
Sep 9, 2020
Start date
Sep 16, 2020
Primary completion
Jan 15, 2023
Completion
Jan 15, 2023
Results posted
Apr 30, 2024
Last update
Apr 30, 2024

Study contacts

Raymond Cho, MD, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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