NCT05180526

Assessment of Safety , Clinical Efficacy with QLETLI in Non-infectious Uveitis (UV)

A Multicenter, Prospective, Post-marketing Evaluation of QLETLI (Adalimumab Injection) Treatment Clinical Study on Efficacy and Safety of Non-infectious Uveitis (UV)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, post-marketing clinical study with a total of 60 uveitis (UV) subjects planned to be enrolled. Screening period (-2\~0 weeks) ,Treatment period (1-22 weeks), Follow-up period, At the same time, plasma concentration will be determined

Detailed description

This is a multicenter, prospective, post-marketing clinical study with a total of 60 uveitis (UV) subjects planned to be enrolled. Screening period (-2\~0 weeks) : the inclusion and exclusion criteria were evaluated, and those meeting the criteria could enter the treatment period. Treatment period (1-22 weeks) : Eligible subjects with non-infectious uveitis were given an initial subcutaneous injection of 80 mg at week 1, followed by a subcutaneous injection of 40 mg of Glorio (adamuzumab injection) every other week from week 1 to week 22 (a total of 12 doses). Follow-up period: Follow-up for safety and/or efficacy is recommended at 6, 12, 24, and 32 weeks after initiation of the study drug. A final visit will be made at 32 weeks. During the study, if the condition of the subjects or their symptoms and signs become worse, the investigator can adjust the use of drugs for uveitis other than study drugs according to the actual situation of the subjects. At the same time, plasma concentration will be determined before D1, D78 (week 12), and D162 (week 24); Immunogenicity analysis was performed before D1 administration, before D78 (week 12), before D162 (week 24) and before D218 (week 32)

Conditions

• Uveitis

Interventions

Type	Name	Description
DRUG	QLETLI	80 mg was given subcutaneously at week 1, followed by 40 mg of Glorio (adamuzumab injection) every other week from week 1 to week 22 (12 doses).

Timeline

• Start date: 2021-12-27
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2022-01-06
• Last updated: 2024-12-24

Locations

7 sites across 1 country: China