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

NCT05133297 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-09-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hangzhou Highlightll Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2022-12-19
Completion
2023-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133297 on ClinicalTrials.gov