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TLL-018 in Patients With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to csDMARDs

NCT07748728 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-06

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled parallel-group Phase II study. The study aims to evaluate the efficacy and safety of TLL-018 in adult patients with moderate to severe active rheumatoid arthritis who have inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

TLL-018

Treatment group: TLL-018 20 mg BID in Period 1 → TLL-018 20 mg BID in Period 2

DRUG

Placebo

Placebo group: Placebo BID in Period 1 → TLL-018 20 mg BID in Period 2

Sponsors & Collaborators

  • Hangzhou Highlightll Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zeng Xiaofeng Zeng, PhD · Peking Union Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-08-14
Primary Completion
2027-07-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07748728 on ClinicalTrials.gov