Actively Recruiting
Safety and Efficacy of TollB-001 Tablets in Moderate to Severe Rheumatoid Arthritis
Led by Toll Biotech Co. Ltd. (Beijing) · Updated on 2026-02-17
24
Participants Needed
6
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of TollB-001 Tablets in Moderate to Severe Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years (inclusive) at the time of consent
- Diagnosed with rheumatoid arthritis according to established criteria
- Disease Activity Score (DAS28-CRP) greater than 3.2 at screening
- Elevated C-reactive protein (CRP) or high-sensitivity CRP at screening
- Prior inadequate response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD)
- Agreement to discontinue csDMARDs during the study
- Use of effective contraception during the study and for 3 months after last dose for participants of childbearing potential
- Negative pregnancy test for female participants of childbearing potential
- Able and willing to comply with study procedures and provide informed consent
You will not qualify if you...
- Hypersensitivity to study drug or its components
- Functional class IV rheumatoid arthritis or bedridden/wheelchair-bound long term
- Prior use of Janus kinase inhibitors, biologic DMARDs, or participation in related clinical trials
- Use of csDMARDs or other immunosuppressive drugs within specified timeframes before randomization
- Use of corticosteroids, interferon, opioid drugs, or certain other treatments within defined periods before study start
- History or presence of other systemic inflammatory diseases except rheumatoid arthritis
- Active or history of certain infections including tuberculosis and chronic infections
- Poorly controlled severe diseases such as diabetes, hypertension, kidney, liver, heart, respiratory, or gastrointestinal diseases
- Recent major surgery or expected surgery after enrollment
- Blood count abnormalities below specified thresholds
- Positive tests for hepatitis B or C, HIV, or syphilis
- Drug or alcohol abuse within last 6 months
- Participation in other clinical trials or recent blood donation or transfusion
- Any condition deemed by the investigator to affect study participation or results
AI-Screening
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Trial Site Locations
Total: 6 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Actively Recruiting
2
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
3
Puyang Oilfield General Hospital
Puyang, Henan, China
Actively Recruiting
4
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Actively Recruiting
5
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Actively Recruiting
6
Linfen Central Hospital
Linfen, Shanxi, China
Actively Recruiting
Research Team
W
Weili Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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