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Monoclonal Antibodies

Tildrakizumab for Nail Psoriasis

Phase 3
Recruiting
Research Sponsored by Sun Pharma Global FZE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by Investigator).
Body Surface Area (BSA) involvement of ≥10%.
Timeline
Screening 1 day
Treatment Varies
Follow Up week 52
Awards & highlights

Study Summary

This trial will test the effectiveness and safety of tildrakizumab in treating people with moderate to severe nail psoriasis.

Who is the study for?
This trial is for people with moderate to severe nail psoriasis who haven't had enough relief from topical treatments, light therapy, or other systemic therapies. They should have a history of plaque-type psoriasis for at least 6 months and meet specific severity scores (mNAPSI ≥20, s-PGA ≥3, PASI ≥12). Those with allergies to Tildrakizumab ingredients, non-plaque psoriasis types, fungal nail infections or previous use of IL-23/Th-17 inhibitors can't participate.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Tildrakizumab compared to a placebo in treating nail psoriasis. It's a Phase 3b trial where participants are randomly assigned either the drug or placebo to see if there's an improvement in their condition.See study design
What are the potential side effects?
While not specified here, drugs like Tildrakizumab may cause side effects such as injection site reactions, upper respiratory infections, headache and fatigue. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had severe plaque psoriasis for at least 6 months.
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Over 10% of my body is affected by my condition.
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I have had severe plaque psoriasis for at least 6 months.
Select...
My nail psoriasis is moderate to severe, with a high mNAPSI score.
Select...
I have severe psoriasis with a significant area of my body affected.

Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 1 day for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of subjects who achieve at least a 75% improvement from baseline in totalmNAPSI at Week 28.
Secondary outcome measures
The proportion of subjects with a score of "0 - normal" or "1 - minimal nail psoriasis" and at least a 2-point decrease from baseline at Week 28 as measured by the ViSENPsO.
The proportion of subjects with at least 3 point decrease from baseline, in Nail Pain NRS score in subjects with baseline nail pain NRS score of >3
Other outcome measures
The percentage of subjects with Major Adverse Cardiovascular Events.
The percentage of subjects with incidence, seriousness, and severity of all adverse events.
The percentage of subjects with injection site reactions (eg. pain, erythema, edema etc)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment1 Intervention
Group II: Arm BPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tildrakizumab
2019
Completed Phase 4
~190

Find a Location

Who is running the clinical trial?

Sun Pharma Global FZELead Sponsor
33 Previous Clinical Trials
10,055 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedLead Sponsor
64 Previous Clinical Trials
13,415 Total Patients Enrolled

Media Library

Tildrakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03897075 — Phase 3
Plaque Psoriasis Research Study Groups: Arm B, Arm A
Plaque Psoriasis Clinical Trial 2023: Tildrakizumab Highlights & Side Effects. Trial Name: NCT03897075 — Phase 3
Tildrakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03897075 — Phase 3

Frequently Asked Questions

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

Are there any unfilled vacancies in this experiment for new test subjects?

"That is correct, the online information provides evidence that the study is actively looking for enrollees. The trial was established on May 13th, 2021 and was most recently updated on August 26th, 2022. In total, 210 individuals are needed for the 16 different locations."

Answered by AI

What are Tildrakizumab's most common side effects?

"Tildrakizumab's safety is estimated to be a 3. This is based off the fact that it is a Phase 3 trial, indicating that there is both some efficacy data and multiple rounds of safety data."

Answered by AI

Where can people go to participate in this research?

"There are currently 16 trial sites operational, with more located in Metairie, Webster, and Houston. If you are interested in enrolling, it may be best to choose a site near to your location to limit travel."

Answered by AI

How many people are being enrolled in this clinical trial?

"In order to carry out this research 210 patients that meet the pre-determined requirements must enroll. Eligible individuals can choose to participate at Clinical Trials Management, LLC (Site 12) in Metairie, Louisiana or Center for Clinical Studies, LTD.LLP (Site 02) in Webster, Texas."

Answered by AI

Are there any other ongoing investigations using Tildrakizumab?

"Tildrakizumab was first researched in 2020 at Site 33. Out of the 18,245 completed clinical trials since then, 10 are still active. A large portion of these ongoing studies are based in Metairie, Louisiana."

Answered by AI

Is this a new or unique clinical trial?

"There are 10 ongoing trials for Tildrakizumab in 49 cities across 9 countries. The earliest study for Tildrakizumab was conducted in 2020 and involved 120 participants. The trial completed its Phase 2 & 3 drug approval stage in 2020 and 18,245 studies have been completed since then."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New York
How old are they?
18 - 65
What site did they apply to?
California Dermatology & CRI (Site 13)
Forest Hills Dermatology Group (Site 01)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Forest Hills Dermatology Group (Site 01): < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis
2021. "Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03897075.
All > Psoriasis > Plaque Psoriasis
~25 spots leftby Apr 2025
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