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Monoclonal Antibodies

Tildrakizumab SC Injection for Psoriatic Arthritis

Phase 3
Waitlist Available
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
Be older than 18 years old
Must not have
Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.
Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of IMP.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 124
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is studying how well treatment with atezolizumab (MPDL3280A) works in patients with stage III non-small cell lung cancer.

Who is the study for?
This trial is for patients with Psoriatic Arthritis who completed a previous study without early discontinuation. Participants must understand the study requirements, agree to follow them, and provide written consent. Women of childbearing potential must abstain from sex or use dual contraception; pregnant or breastfeeding women are excluded.
What is being tested?
The trial is testing Tildrakizumab injections in an open-label phase 3 setting to evaluate its long-term safety and effectiveness in treating Psoriatic Arthritis. Patients will receive subcutaneous injections as part of their treatment regimen.
What are the potential side effects?
While specific side effects are not listed here, Tildrakizumab may cause reactions at the injection site, increase infection risk, and potentially lead to immune system-related issues due to its nature as an immunosuppressive drug.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I agree to either not have heterosexual sex or use two forms of birth control.
Select...
I am not pregnant, breastfeeding, nor planning to during the study or up to 17 weeks after.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 124
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 124 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50
Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TILD q12 weeksExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Sun Pharma Global FZELead Sponsor
33 Previous Clinical Trials
9,501 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
286 Patients Enrolled for Psoriatic Arthritis
Sun Pharmaceutical Industries LimitedLead Sponsor
69 Previous Clinical Trials
13,145 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
286 Patients Enrolled for Psoriatic Arthritis

Media Library

Tildrakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04991116 — Phase 3
Psoriatic Arthritis Research Study Groups: TILD q12 weeks
Psoriatic Arthritis Clinical Trial 2023: Tildrakizumab Highlights & Side Effects. Trial Name: NCT04991116 — Phase 3
Tildrakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04991116 — Phase 3
Psoriatic Arthritis Patient Testimony for trial: Trial Name: NCT04991116 — Phase 3
~146 spots leftby Sep 2025
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