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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHangzhou Highlightll Pharmaceutical Co., Ltd

About this trial

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).

Eligibility criteria

Qualifiers

1 Aged 18 to 70 years inclusive, any sex; body mass index [BMI = weight (kg)/height² (m²)] ≤ 35 kg/m².

Disqualifiers

1 Evidence or diagnosis of other rheumatic diseases prior to screening (secondary Sjögren's syndrome excluded), including systemic lupus erythematosus, psoriatic arthritis, mixed connective tissue disease, primary Sjögren's syndrome, dermatomyositis, polymyositis, systemic sclerosis, and ankylosing spondylitis.

Trial design

Treatments tested in this trial

  • TLL-018
  • Placebo

Treatment groups

90 Participants
are divided into 2 treatment groups