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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

Documentation of moderate-severe psoriasis or atypical psoriasis

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months

Awards & highlights

Study Summary

This trial looks at whether a drug called Tildrakizumab can help treat psoriasis by reducing the activity of a protein called IL-23.

Who is the study for?

This trial is for adults with moderate to severe psoriasis or atypical psoriasis who can give informed consent and follow study requirements. It's not for those who've had systemic psoriasis treatment in the last 3 months, have tuberculosis, a serious infection, or an active cancer.Check my eligibility

What is being tested?

The trial studies how Tildrakizumab, a medication that blocks IL-23, affects immune cells in skin lesions caused by psoriasis. The goal is to predict how well patients with inflammatory skin diseases respond to this treatment.See study design

What are the potential side effects?

Tildrakizumab may cause side effects such as infections due to weakened immune responses, allergic reactions at the injection site, headache and upper respiratory infections. Each patient's experience with side effects might vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with moderate to severe psoriasis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Psoriasis Area and Severity Index (PASI) Score from Baseline to 3 months

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tildrakizumab treatmentExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tildrakizumab

2019

Completed Phase 4

~190

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,515 Total Patients Enrolled

Sun Pharmaceutical Industries LimitedIndustry Sponsor

64 Previous Clinical Trials

13,471 Total Patients Enrolled

Raymond Cho, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco

4 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Tildrakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04541329 — Phase 4

Plaque Psoriasis Research Study Groups: Tildrakizumab treatment

Plaque Psoriasis Clinical Trial 2023: Tildrakizumab Highlights & Side Effects. Trial Name: NCT04541329 — Phase 4

Tildrakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04541329 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment size for this experiment?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this research effort, initially posted to the website on September 16th 2020, is actively recruiting potential participants. 40 volunteers are required for this study at a single location."

Answered by AI

Is enrollment for the clinical trial still ongoing?

"Affirmative. The clinicaltrials.gov information shows that this experiment is actively seeking participants, having been posted on September 16th of 2020 and most recently amended on June 2nd 2022. 40 volunteers are being sought at one clinic location."

Answered by AI

Is this the inaugural iteration of a study such as this?

"Since 2020, Sun Pharma Global FZE has been studying Tildrakizumab. After successful completion of the Phase 1 trial in 2020 involving 120 people, this drug was approved for Phases 2 and 3 studies. Currently, 10 trials are active across 52 cities worldwide spanning 9 different nations."

Answered by AI

Are there any past experiments concerning Tildrakizumab?

"At present, there are 10 ongoing studies of Tildrakizumab with 2 in their final phase. Although most of the trials for this drug are concentrated in Milwaukee, Wisconsin; there exists 106 sites conducting investigations into its efficacy."

Answered by AI