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Monoclonal Antibodies

Tildrakizumab for Psoriasis

Phase 4
Recruiting
Led By Raymond Cho, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Patients with moderate-severe psoriasis or > 5% body surface area affected.
Must not have
Taking systemic immunosuppressives in the last 4 weeks
Active systemic malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial will study how well an experimental drug works in people with psoriasis.

Who is the study for?
This trial is for adults over 18 with moderate to severe psoriasis, affecting more than 5% of their body. It's not suitable for those on systemic immunosuppressives in the last month, pregnant or breastfeeding individuals, people with severe immune deficiencies, active tuberculosis or other serious infections, and anyone with an active systemic cancer.
What is being tested?
The study is testing Tildrakizumab injections to see how they affect skin and blood immune cells in psoriasis patients. The goal is to understand the changes in immune function after starting treatment with this IL23 blocker.
What are the potential side effects?
Tildrakizumab may cause side effects such as upper respiratory infections, headache, fatigue, injection site reactions like pain or swelling, and possibly allergic reactions. Long-term use might increase infection risk due to its effect on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My psoriasis is severe or covers more than 5% of my body.
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My psoriasis covers more than 5% of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken any immunosuppressive drugs in the last 4 weeks.
Select...
I have an active cancer that is affecting my whole body.
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I have a severe immune system problem.
Select...
I do not have tuberculosis or any serious infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tildrakizumab treatmentExperimental Treatment1 Intervention
Biological/vaccine: tildrakizumab

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,166 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedIndustry Sponsor
69 Previous Clinical Trials
13,785 Total Patients Enrolled
Raymond Cho, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
57 Total Patients Enrolled

Media Library

Tildrakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05390515 — Phase 4
Plaque Psoriasis Research Study Groups: Tildrakizumab treatment
Plaque Psoriasis Clinical Trial 2023: Tildrakizumab Highlights & Side Effects. Trial Name: NCT05390515 — Phase 4
Tildrakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05390515 — Phase 4
~2 spots leftby Sep 2025
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