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

NCT07408024 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

Group 1: TollB-001 100mg qd po; Group 2: TollB-001 200mg qd po; Group 3: TollB-001400mg qd po

for 4 weeks

DRUG

Placebo

matching placebo qd po for 4 weeks

Sponsors & Collaborators

  • Toll Biotech Co. Ltd. (Beijing)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2026-12-31
Completion
2026-12-31

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 NCT07408024 on ClinicalTrials.gov