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Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)
NCT04314531 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .
Conditions Studied
Interventions
- DRUG TILD
- DRUG matching placebo injections
Study Locations (20)
Other
- Sunpharma Site 64 — Brno
- Sunpharma Site 97 — Prague
- Sunpharma Site 63 — Zlín
- Sunpharma Site 73 — Berlin
- Sunpharma Site 92 — Herne
Florida
- Sunpharma site no. 04 — Miami Beach
- Sunpharma site no. 02 — New Port Richey
- Sunpharma site no. 07 — Tamarac
Texas
- Sunpharma site no. 09 — Lubbock
- Sunpharma site no. 03 — San Antonio
- Sunpharma site no. 01 — Tomball
California
- Sunpharma site no. 12 — Covina
Missouri
- Sunpharma site no. 05 — Springfield
Nebraska
- Sunpharma site no. 10 — Lincoln
South Carolina
- Sunpharma site no. 11 — Greenville
Washington
- Sunpharma site no. 06 — Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04314531
The ClinicalTrials.gov registry entry for NCT04314531 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries Limited, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Active Psoriatic Arthritis appearing as the primary indexed condition, and to 2 interventions — of which TILD is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04314531 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04314531 about?
NCT04314531 is a clinical study titled "Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)". This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .
What is the current status of trial NCT04314531?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2020-07-01. Estimated completion is 2026-04.
What conditions does trial NCT04314531 study?
This clinical trial studies the following conditions: Active Psoriatic Arthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04314531?
The interventions under investigation include: TILD (DRUG), matching placebo injections (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04314531?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04314531 being conducted?
This trial has 20 study locations across California, Florida, Missouri, Nebraska, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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