NCT03552276

Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

A Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab

Detailed description

Subjects have rolled over from parent study, i.e., CLR\_16\_23, into the long-term extension study CLR\_18\_07. The study has been open label post 1 year completion.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	SUNPG18_07 I (Tildrakizumab 200 mg)	injection
DRUG	SUNPG18_07 II (Tildrakizumab 100 mg)	injection

Timeline

• Start date: 2018-07-11
• Primary completion: 2023-09-18
• Completion: 2023-09-18
• First posted: 2018-06-11
• Last updated: 2024-11-21
• Results posted: 2024-11-21

Locations

66 sites across 8 countries: United States, Argentina, Hungary, Mexico, Poland, Russia, Spain, Ukraine

Regulatory

• FDA-regulated drug study