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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.
Must not have
Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
Subjects who have been placed in an institution on official or judicial orders.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 24 and 52
Awards & highlights
Pivotal Trial

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.
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.
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
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I am 18 years old or older.
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I have been treated with anti-TNF medications for Psoriasis or Psoriatic Arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have another active cancer, including skin cancers.
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I am currently institutionalized by legal or official order.
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I am scheduled for surgery before the 24-week check-up for a condition I had before joining the trial.
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I have not lost or donated more than 400 mL of blood in the last 8 weeks.
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I have a history of hepatitis B, C, or HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 24 and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 24 and 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of subjects who achieve American College of Rheumatology [ACR20]
Secondary study objectives
Change from Baseline in American College of Rheumatology Response Criteria Components Score
In subjects with active Psoriasis and Body surface area ≥3%, the proportion of subjects
Nail plate
+3 more
Other study objectives
The change from Baseline
The change from Baseline in American College of Rheumatology Response Criteria Components Score
The proportion of subjects achieving American College of Rheumatology [ACR20]
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
69 Previous Clinical Trials
13,323 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
~41 spots leftby May 2025
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