RecruitingPhase 2NCT07408024

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Study to Evaluate the Efficacy and Safety of TollB-001 Tablets in Patients With Moderate to Severe Active Rheumatoid Arthritis


Sponsor

Toll Biotech Co. Ltd. (Beijing)

Enrollment

24 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of a new oral drug called TollB-001 in adults with moderate to severe rheumatoid arthritis (RA) — a condition where the immune system attacks the joints causing pain, swelling, and stiffness — whose symptoms have not improved adequately with standard medications. **You may be eligible if...** - You are 18 to 70 years old - You have been diagnosed with rheumatoid arthritis - Your disease is moderately to severely active (DAS28-CRP score above 3.2) - You have elevated inflammation markers in your blood - You have previously tried at least one conventional RA medication (such as methotrexate or hydroxychloroquine) without adequate benefit **You may NOT be eligible if...** - You have previously used JAK inhibitor drugs (like tofacitinib, baricitinib) or biologic RA drugs - You have other immune or inflammatory conditions beyond RA - You have an active infection, tuberculosis, or history of cancer - You have severe heart, liver, or kidney disease - You are pregnant, breastfeeding, or not using effective contraception - You have positive HIV, active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

for 4 weeks

DRUGPlacebo

matching placebo qd po for 4 weeks


Locations(6)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Puyang Oilfield General Hospital

Puyang, Henan, China

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

Linfen Central Hospital

Linfen, Shanxi, China

View Full Details on ClinicalTrials.gov

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NCT07408024


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