NCT06020144

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

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, double-dummy, tofacitinib-parallel-group, 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	TLL-018	Oral tablets administered 2pieces BID for 52 weeks.
DRUG	Tofacitinib	Oral tablets administered 1pieces BID for 52 weeks.

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-02-28
• Completion: 2025-09-30
• First posted: 2023-08-31
• Last updated: 2023-11-18

Locations

1 site across 1 country: China