NCT04314531

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• 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: 2025-06-04
• Completion: 2026-04-01
• First posted: 2020-03-19
• Last updated: 2026-03-10

Locations

49 sites across 9 countries: United States, Australia, Czechia, Germany, India, Japan, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study