Your session is about to expire
← Back to Search
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 124
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 124
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
9,499 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
281 Patients Enrolled for Psoriatic Arthritis
Sun Pharmaceutical Industries LimitedLead Sponsor
69 Previous Clinical Trials
13,166 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
281 Patients Enrolled for Psoriatic Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have PsA and you met all the requirements for the main study, completed the treatment, and did not have to stop early for any reasons.You must agree to comply with the study restrictions, scheduled treatments, laboratory assessments, and other study proceduresI understand what participating in this study involves.I agree to either not have heterosexual sex or use two forms of birth control.I am not pregnant, breastfeeding, nor planning to during the study or up to 17 weeks after.
Research Study Groups:
This trial has the following groups:- Group 1: TILD q12 weeks
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Psoriatic Arthritis Patient Testimony for trial: Trial Name: NCT04991116 — Phase 3