drugset / Trial / NCT07408024

Safety and Efficacy of TollB-001 Tablets in Moderate to Severe Rheumatoid Arthritis

NCT07408024 ↗

Phase 2 Recruiting 24 enrolled Toll Biotech Co. Ltd. (Beijing)
RandomizedSequentialQuadruple-blindTreatment

Summary

The goal of this study is to evaluate the safety, pharmacokinetic (PK) characteristics, and preliminary efficacy of a new oral chemical drug in : adults aged 18-70 years (male or female) with moderate to severe active rheumatoid arthritis (RA), who have had inadequate response to or intolerance of at least one conventional synthetic disease-modifying antirheumatic drug (csDMARDs) . Participants will take the assigned study drug (either tollB-001 Tablets or placebo) once daily orally for 4 weeks, follow up for 1 week.

Timeline

Start
2025-09-10
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject TollB-001 Small molecule 100 mg Oral
Subject TollB-001 Small molecule 200 mg Oral
Subject TollB-001 Small molecule 400 mg Oral

Indications