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ACTIVE NOT RECRUITING
NCT04314531
PHASE3

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

Sponsor: Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

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 .

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

296

Start Date

2020-07-01

Completion Date

2026-04

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DRUG

TILD

one 1 mL injection of study medication

DRUG

matching placebo injections

one 1 mL injection of placebo

Locations (49)

Sunpharma site no. 12

Covina, California, United States

Sunpharma site no. 04

Miami Beach, Florida, United States

Sunpharma site no. 02

New Port Richey, Florida, United States

Sunpharma site no. 07

Tamarac, Florida, United States

Sunpharma site no. 05

Springfield, Missouri, United States

Sunpharma site no. 10

Lincoln, Nebraska, United States

Sunpharma site no. 11

Greenville, South Carolina, United States

Sunpharma site no. 09

Lubbock, Texas, United States

Sunpharma site no. 03

San Antonio, Texas, United States

Sunpharma site no. 01

Tomball, Texas, United States

Sunpharma site no. 06

Spokane, Washington, United States

Sunpharma Site 39

Phillip, Australian Capital Territory, Australia

Sunpharma site no. 08

Hobart, Tasmania, Australia

Sunpharma Site 64

Brno, Czechia

Sunpharma Site 97

Prague, Czechia

Sunpharma Site 63

Zlín, Czechia

Sunpharma Site 73

Berlin, Germany

Sunpharma Site 92

Herne, Germany

Sunpharma Site 111

Surat, Gujarat, India

Sunpharma Site 110

Bangalore, Karnataka, India

Sunpharma Site 107

Belagavi, Karnataka, India

Sunpharma Site 109

Hubli, Karnataka, India

Sunpharma Site 108

Pune, Maharashtra, India

Sunpharma Site 112

Hyderabad, Telangana, India

Sunpharma Site 106

Lucknow, Uttar Pradesh, India

Sunpharma Site 113

Kochi, India

Sunpharma Site 84

Nagoya, Aichi-ken, Japan

Sunpharma Site 89

Kitakyushu, Fukuoka, Japan

Sunpharma Site 86

Sendai, Miyagi, Japan

Sunpharma Site 24

Miyazaki, Miyazaki, Japan

Sunpharma Site 91

Mitaka, Tokyo, Japan

Sunpharma Site 85

Shinjuku, Tokyo, Japan

Sunpharma Site 90

tabashi City, Tokyo, Japan

Sunpharma Site 22

Kitakyushu-shi, Japan

Sunpharma Site 88

Kumamoto, Japan

Sunpharma Site 87

Osaka, Japan

Sunpharma Site 23

Tsu, Japan

Sunpharma Site 93

Bialystok, Poland

Sunpharma Site 95

Bialystok, Poland

Sunpharma Site 94

Lublin, Poland

Sunpharma Site 74

Poznan, Poland

Sunpharma Site 96

Warsaw, Poland

Sunpharma Site 18

Incheon, South Korea

Sunpharma Site 20

Seoul, South Korea

Sunpharma Site 19

Seoul, South Korea

Sunpharma Site 75

A Coruña, Spain

Sunpharma Site 71

Córdoba, Spain

Sunpharma Site 100

Madrid, Spain

Sunpharma Site 72

Seville, Spain