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Monoclonal Antibodies

Tildrakizumab for Psoriatic Arthritis

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
Subject is ≥ 18 years of age at time of Screening.
Subjects must have prior exposure to anti-TNF agent(s) use for the treatment of PsO or PsA.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
Awards & highlights

Study Summary

This trial will test the efficacy and safety of tildrakizumab in people with active psoriatic arthritis.

Who is the study for?
This trial is for adults over 18 with active psoriatic arthritis who've tried anti-TNF agents before. They must not have any current cancer, major blood loss recently, or a history of substance abuse in the last two years. Participants need to use effective birth control and can't be enrolled in another study or have certain infections.Check my eligibility
What is being tested?
The trial tests Tildrakizumab (TILD), an investigational medication against a placebo injection to see if it's effective and safe for treating psoriatic arthritis. It's a Phase III study where participants are randomly assigned to receive either TILD or placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects aren't listed here, clinical trials like this often monitor for reactions at the injection site, allergic responses, potential infections due to immune system changes, and general symptoms like fatigue or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have been treated with anti-TNF medications for Psoriasis or Psoriatic Arthritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 1, week 4, week 8, week 12, week 16, week 20, week 24 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 1, week 4, week 8, week 12, week 16, week 20, week 24 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 American College of Rheumatology [ACR20]
Secondary outcome measures
Change from Baseline in American College of Rheumatology Response Criteria Components Score
Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score
In subjects with active Psoriasis and Body surface area ≥3% those with involvement of nails , the change from Baseline in nail psoriasis severity index
+19 more
Other outcome measures
The change from Baseline
The change from Baseline in American College of Rheumatology Response Criteria Components Score
The change from Baseline in the levels of "Metabolic Biomarkers"
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment1 Intervention
Group II: Arm BPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Sun Pharma Global FZELead Sponsor
33 Previous Clinical Trials
9,679 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
936 Patients Enrolled for Psoriatic Arthritis
Sun Pharmaceutical Industries LimitedLead Sponsor
64 Previous Clinical Trials
13,039 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
936 Patients Enrolled for Psoriatic Arthritis

Media Library

Tildrakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04314544 — Phase 3
Psoriatic Arthritis Research Study Groups: Arm A, Arm B
Psoriatic Arthritis Clinical Trial 2023: Tildrakizumab Highlights & Side Effects. Trial Name: NCT04314544 — Phase 3
Tildrakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04314544 — Phase 3

Frequently Asked Questions

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

How many participants are necessary for this clinical trial?

"Yes, that is correct. The clinical trial was posted on 7/1/2020 and was most recently edited on 8/26/2022. The trial is enrolling 472 participants at 59 locations."

Answered by AI

What is the official government opinion on TILD's safety and efficacy?

"TILD is a Phase 3 trial, which means that there is supporting data for its efficacy and safety. Our team at Power rates the safety of TILD as a 3."

Answered by AI

Can you list all the places where this research project is taking place?

"There are 59 medical research facilities with open slots for this trial, spread out across the nation. A few notable locations are Paramount Medical Research in Middleburg Heights, Sunpharma Site no 31 in Mesa, and GNP Research in Hollywood."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
West Broward Rheumatology Associates
Sunpharma Site no 31
Other
Sunpharma Site no 29
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I’m currently taking Cosentyx and it is not working as well as it used to.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
2020. "Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04314544.
All > Psoriatic Arthritis
~10 spots leftby Jun 2024
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