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NCT04314531 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)
A Phase 3 study of Active Psoriatic Arthritis, sponsored by Sun Pharmaceutical Industries Limited.
- Active
- Registry status
- Phase 3
- Development phase
- 296
- Enrollment target
- 20
- Study locations
NCT04314531: Active Phase 3 study of Active Psoriatic Arthritis, sponsored by Sun Pharmaceutical Industries Limited.
NCT04314531 is a Phase 3 study of Active Psoriatic Arthritis that is active but no longer recruiting, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 296 participants, roughly in line with the 323-participant average among 3 other Active Psoriatic Arthritis trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04314531, a Phase 3 study of Active Psoriatic Arthritis, is active but no longer recruiting, sponsored by Sun Pharmaceutical Industries Limited.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 296 participants
- Enrollment target
- 20
- Study locations
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 .
Primary Outcome
the proportion of subjects achieving a 20% reduction from Baseline in response criteria
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 |
What the registry record for NCT04314531 still lists
NCT04314531 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 323-participant average among 3 other Active Psoriatic Arthritis trials with a reported enrollment target.
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.
NCT04314531 names 20 study sites across 12 states, led by Other, Florida, Texas.
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.
What interventions are being tested in trial NCT04314531?
The interventions under investigation include: TILD (DRUG), matching placebo injections (DRUG).
Who is sponsoring clinical trial NCT04314531?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
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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