NCT05133297

The Safety and Efficacy of TLL-018 in Active Rheumatoid Arthritis

A Phase 2A, Randomized, Double-blind, Double-dummy, Tofacitinib-parallel-group Study to Evaluate the Safety and Efficacy of TLL-018 in Active Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Methotrexate.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, double-dummy, tofacitinib-parallel-group, phase 2A study to assess the safety and efficacy of TLL-018 in active rheumatoid arthritis subject who had an inadequate response or intolerance to methotrexate.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	TLL-018	Oral tablets administered at dose1 BID daily for 24 weeks.
DRUG	TLL-018	Oral tablets administered at dose2 BID daily for 24 weeks.
DRUG	TLL-018	Oral tablets administered at dose3 BID daily for 24 weeks.
DRUG	Tofacitinib	Oral tablets administered at 5 mg BID daily for 24 weeks.

Timeline

• Start date: 2022-02-16
• Primary completion: 2022-12-19
• Completion: 2023-05-30
• First posted: 2021-11-24
• Last updated: 2023-09-05

Locations

1 site across 1 country: China