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Monoclonal Antibodies
Tildrakizumab 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
Subjects must have no prior exposure to anti-tumor necrosis factor (anti-TNF) agent(s) use for the treatment of PsO or PsA.
Subject is ≥ 18 years of age at time of Screening.
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 compare the effects of tildrakizumab to placebo in people with active PsA who have not taken anti-TNF drugs before. The study is blinded, meaning neither the participants nor the researchers will know who is receiving tildrakizumab or placebo until the end.
Who is the study for?
This trial is for adults diagnosed with active Psoriatic Arthritis (PsA) for at least 6 months, who have never used anti-TNF treatments. Participants must test negative for certain antibodies and agree to use effective contraception if of childbearing potential. Exclusions include a history of serious infections, heart issues within the past 6 months, drug abuse in the last two years, or any condition that might compromise study participation.Check my eligibility
What is being tested?
The INSPIRE 2 study is testing the effectiveness and safety of Tildrakizumab (TILD), an investigational medication, against a placebo in individuals who haven't previously been treated with anti-TNF drugs. This Phase 3 trial randomly assigns participants to receive either TILD or placebo injections without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with medications like Tildrakizumab may include injection site reactions, increased risk of infection due to immune system suppression, headaches, fatigue and possibly allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never used anti-TNF drugs for psoriasis or psoriatic arthritis.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured timepoints
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured timepoints
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 health assessment questionnaire - disability index (HAQ-DI) score
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3% those with involvement of nails, the change from Baseline in nail psoriasis severity index
In anti-tumor necrosis factor naïve subjects with active Psoriasis and body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis
+20 moreOther outcome measures
The change from Baseline in Leeds Enthesitis Index, Leeds Dactylitis Index, Bath Ankylosing Spondylitis Disease Activity Index and Health Assessment Questionnaire Disability Index score
The change from Baseline in the levels of "Metabolic Biomarkers"
The proportion of subjects achieving American College of Rheumatology [ACR20]
+9 moreTrial 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
9,859 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
936 Patients Enrolled for Psoriatic Arthritis
Sun Pharmaceutical Industries LimitedLead Sponsor
64 Previous Clinical Trials
13,219 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
936 Patients Enrolled for Psoriatic Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe health issues that could make this study unsafe for me.I have an active cancer, including skin cancers like basal or squamous cell carcinoma or melanoma.I am not currently institutionalized by court or government order.I am scheduled for surgery before the Week 52 check-up for a condition I had before joining the study.I haven't had serious infections or been on antibiotics in the last 28 days.I have not donated or lost 400 mL or more of blood in the last 8 weeks.I have never used anti-TNF drugs for psoriasis or psoriatic arthritis.I agree to use effective birth control or abstain from sex during and after the trial.I have been diagnosed with active Psoriatic Arthritis for at least 6 months.You don't have specific antibodies called rheumatoid factor and anti-cyclic citrullinated peptide antibodies.You have struggled with alcohol or drug abuse in the past 2 years.I have not had a heart attack, unstable chest pain, or stroke in the last 6 months.I have a history of hepatitis B, C, or HIV.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm A
Awards:
This trial has 1 awards, including:- 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: NCT04314531 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research being conducted at several hospitals in America?
"49 different hospitals and research centres are participating in this trial, including Sunpharma Site 61 in Grapevine, Sunpharma Site 55 in Voorhees, and Sunpharma Site 37 in Wichita, as well as other locations."
Answered by AI
How many total participants are in this experiment?
"In order to carry out this clinical trial, 292 patients who fit the inclusion criteria will be needed. These patients will come from different locations, such as Sunpharma Site 61 in Grapevine, Texas and Sunpharma Site 55 in Voorhees, New jersey."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
California
Florida
How old are they?
65+
What site did they apply to?
Sunpharma site no. 12
Sunpharma Site 42
Sunpharma Site 44
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
relief and money from study.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Sunpharma site no. 02: < 48 hours
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