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

Sponsor
Hangzhou Highlightll Pharmaceutical Co., Ltd
Study ID
NCT05133297
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 16, 2022
Status verified
Sep 2023
Primary completion
Dec 19, 2022
Completion
May 30, 2023

Study Design

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

Arms

  • Experimental: Sequence 1
    TLL018 tablets, 1piece,BID
  • Experimental: Sequence 2
    TLL018 tablets, 2pieces, BID
  • Experimental: Sequence 3
    TLL018 tablets, 3pieces, BID
  • Active Comparator: Sequence 4
    TOFA tablets, 1pieces, BID

Primary Outcome Measure

Number of Participants American College of Rheumatology 50% (ACR50) Response at Week 12 [ Time Frame: Week 12 ]

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