NCT04314544

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

A 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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 508 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Active Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	TILD	one 1 mL injection of study medication
DRUG	matching placebo injections	one 1 mL injection of placebo

Timeline

• Start date: 2020-07-01
• Primary completion: 2025-03-26
• Completion: 2025-12-22
• First posted: 2020-03-19
• Last updated: 2026-01-16

Locations

97 sites across 12 countries: United States, Canada, Czechia, Estonia, Germany, India, Italy, Poland, Slovakia, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study