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NCT04314544 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
A Phase 3 study of Active Psoriatic Arthritis, sponsored by Sun Pharmaceutical Industries Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 508
- Enrollment target
- 20
- Study locations
NCT04314544: Completed Phase 3 study of Active Psoriatic Arthritis, sponsored by Sun Pharmaceutical Industries Limited.
NCT04314544 is a Phase 3 study of Active Psoriatic Arthritis that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 508 participants, above the 252-participant average among 3 other Active Psoriatic Arthritis trials with a reported enrollment target (102% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04314544, a Phase 3 study of Active Psoriatic Arthritis, has completed, sponsored by Sun Pharmaceutical Industries Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 508 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
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)
Florida
- Sunpharma Site no. 141 - Avon Park
- Sunpharma site no. 21 - Clearwater
- Sunpharma site no. 02 - Hialeah
- Sunpharma Site no 55 - Kissimmee
- Sunpharma Site no. 75 - Margate
- Sunpharma site no. 05 - New Port Richey
- Sunpharma Site no. 76 - Ocoee
- SunPharma Site no 22 - Tamarac
California
- Sunpharma Site no 35 - Covina
- Sunpharma Site no 48 - Encino
- Sunpharma site no. 17 - Fountain Valley
- Sunpharma site no. 15 - Thousand Oaks
Arizona
- Sunpharma Site no 29 - Gilbert
- Sunpharma Site no 30 - Glendale
- Sunpharma Site no 31 - Mesa
Illinois
- Sunpharma Site no 41 - Oak Brook
- Sunpharma Site no 54 - Orland Park
- Sunpharma Site no 38 - Schaumburg
Alabama
- Sunpharma Site no 42 - Dothan
Georgia
- Sunpharma Site no 46 - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 508 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2025-12-22 |
| Phase | Phase 3 |
What the finished NCT04314544 record still lists
NCT04314544 is an interventional study that assigns participants to a tested intervention. The registered 508 participants enrollment target is mid-sized for trials with a published cap, above the 252-participant average among 3 other Active Psoriatic Arthritis trials with a reported enrollment target (102% higher).
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.
NCT04314544 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04314544 about?
NCT04314544 is a clinical study titled "Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)". This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
What is the current status of trial NCT04314544?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 508 participants. The study started on 2020-07-01. Estimated completion is 2025-12-22.
What conditions does trial NCT04314544 study?
This clinical trial studies the following conditions: Active Psoriatic Arthritis.
What interventions are being tested in trial NCT04314544?
The interventions under investigation include: TILD (DRUG), matching placebo injections (DRUG).
Who is sponsoring clinical trial NCT04314544?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04314544 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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