TollB-001 oral tablets for moderate to severe rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, placebo-controlled study gives adults with active moderate to severe RA daily oral doses of TollB-001 at 100 mg, 200 mg, or 400 mg, or placebo for four weeks with one week of follow-up. The main goals are to characterize safety, pharmacokinetics, and preliminary signs of efficacy using clinical measures such as DAS28-CRP and inflammatory biomarkers. Eligible participants must have elevated CRP and prior inadequate response or intolerance to at least one conventional synthetic DMARD. The trial is being conducted at several hospital sites in China and is sponsored by Toll Biotech Co., Ltd.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, regardless of gender.
2. Diagnosis of RA according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.
3. DAS28-CRP \> 3.2 at screening.
4. C-reactive protein (CRP)/high-sensitivity C-reactive protein (hsCRP) ≥ upper limit of normal (ULN) at screening.
5. Prior to the first administration of the study drug, has received continuous treatment with at least one conventional synthetic disease-modifying antirheumatic drug with inadequate response or intolerance, and agrees to discontinue use during the study.
6. Female and male subjects of childbearing potential must use effective contraceptive measures during the study and for 3 months after the last study drug administration. Male subjects whose spouses or partners are females of childbearing potential must also agree to use effective contraceptive measures during the study and for 3 months after the last administration, and shall not donate sperm during this period. Female subjects of childbearing potential must have a negative pregnancy test.
7. Must provide written informed consent and be willing and able to comply with the study protocol (e.g., understand and complete questionnaires, follow the visit schedule, take medications as prescribed).

Exclusion Criteria:

1. Hypersensitivity to the study drug or any of its components.
2. ACR functional class IV or being bedridden/wheelchair-bound for a long time.
3. History or evidence of any of the following diseases:

   Other systemic inflammatory diseases except RA (excluding secondary Sjögren's syndrome), or other joint diseases that may affect efficacy evaluation (e.g., osteoarthritis with significant joint pain).

   Felty's syndrome. Any active malignant tumor or history of malignant tumor. Chronic pain history that may affect study evaluation. Active tuberculosis, latent untreated tuberculosis, or incompletely cured tuberculosis as judged by the investigator and/or specialist.

   History of any persistent or chronic infection. Poorly controlled severe diseases. Major surgery within 8 weeks before randomization or expected to undergo major surgery after enrollment.
4. Positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb) with HBV DNA above the lower limit of detection; positive hepatitis C virus (HCV) antibody with positive HCV-RNA; positive human immunodeficiency virus (HIV) antibody or positive syphilis antibody.
5. Drug or alcohol abuse or dependence at screening, or history of drug or alcohol abuse or dependence within 6 months before randomization.
6. Participation in any clinical trial of drugs or medical devices within 4 weeks or 5 half-lives (whichever is longer) before randomization.
7. Blood donation ≥ 400 mL or receipt of blood transfusion within 3 months before randomization.
8. Any other factors deemed by the investigator to potentially affect the conduct or result evaluation of the study.

Where it's running

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Weili Wang
• Email: wangweili@toll-biotech.com
• Phone: +86 10 80710966

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.