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COMPLETED
NCT06020144
PHASE3

A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs

Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

A randomized, double-blind, double-dummy, positive-controlled, phase 3 study to assess the safety and efficacy of TLL-018 in active rheumatoid arthritis subjects who had an inadequate response or intolerance to Biologic DMARDs.

Official title: A Phase 3, Randomized, Double-Blind, Positive-controlled, Head-to-Head Monotherapy Study Comparing TLL-018 to Tofacitinib in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

459

Start Date

2023-11-15

Completion Date

2026-08-20

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DRUG

TLL-018

Oral tablets administered 2pieces BID for 52 weeks.

DRUG

Tofacitinib

Oral tablets administered 1pieces BID for 52 weeks.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China