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
Study ID
NCT06020144
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TLL-018 — DRUG
    Oral tablets administered 2pieces BID for 52 weeks.
  • Tofacitinib — DRUG
    Oral tablets administered 1pieces BID for 52 weeks.

Study Details

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.

Key Dates

Start date
Nov 15, 2023
Status verified
May 2026
Primary completion
Jan 15, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
459 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: sequence A
    TLL018 tablets, 2piece,BID
  • Active Comparator: sequence B
    Tofacitinib tablets, 1piece,BID

Primary Outcome Measure

Proportion of subjects achieving American College of Rheumatology 50% (ACR50) Response [ Time Frame: Week 24 ]

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