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Tests treatment safety and results for Rheumatoid Arthritis (RA)
Official title Safety and Efficacy of TollB-001 Tablets in Moderate to Severe Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT07408024
What this study is testing
What is Group 1: TollB-001 100mg qd po; Group 2: TollB-001 200mg qd po; Group 3: TollB-001400mg qd po?
Group 1: TollB-001 100mg qd po; Group 2: TollB-001 200mg qd po; Group 3: TollB-001400mg qd po is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for rheumatoid arthritis (ra).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, regardless of gender.
- Diagnosis of RA according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism (EULAR)...
- DAS28-CRP \> 3.2 at screening (joints that have undergone major surgical treatment or intra-articular injection of glucocorticoids or hyaluronic acid...
- C-reactive protein (CRP)/high-sensitivity C-reactive protein (hsCRP) ≥ upper limit of normal (ULN) at screening.
- Prior to the first administration of the study drug, has received continuous treatment with at least one conventional synthetic disease-modifying...
You likely can't join if
- Hypersensitivity to the study drug or any of its components.
- ACR functional class IV or being bedridden/wheelchair-bound for a long time.
- Use of any of the following drugs or treatments: Prior use of Janus kinase (JAK) inhibitors (including but not limited to tofacitinib, baricitinib...
- History or evidence of any of the following diseases: Other systemic inflammatory diseases except RA (excluding secondary Sjögren's syndrome)...
- Any laboratory abnormalities meeting the following criteria at screening: Hemoglobin \< 90.0 g/L. Total white blood cell count \< 2.5 × 10⁹/L...
- Positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb) with HBV DNA above the lower limit of detection; positive...
See the full eligibility criteria
- Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, regardless of gender.
- Diagnosis of RA according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.
- DAS28-CRP \> 3.2 at screening (joints that have undergone major surgical treatment or intra-articular injection of glucocorticoids or hyaluronic acid within 6 weeks before randomization are not counted in the TJC and...
- C-reactive protein (CRP)/high-sensitivity C-reactive protein (hsCRP) ≥ upper limit of normal (ULN) at screening.
- Prior to the first administration of the study drug, has received continuous treatment with at least one conventional synthetic disease-modifying antirheumatic drug (csDMARDs, including methotrexate, chloroquine...
- Female and male people of childbearing potential must use effective contraceptive measures during the study and for 3 months after the last study drug administration. Male people whose spouses or partners are females of...
- 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).
- Hypersensitivity to the study drug or any of its components.
- ACR functional class IV or being bedridden/wheelchair-bound for a long time.
- Use of any of the following drugs or treatments: Prior use of Janus kinase (JAK) inhibitors (including but not limited to tofacitinib, baricitinib, upadacitinib), biologic disease-modifying antirheumatic drugs...
- History or evidence of any of the following diseases: Other systemic inflammatory diseases except RA (excluding secondary Sjögren's syndrome), including but not limited to juvenile chronic arthritis, Crohn's disease...
- Any laboratory abnormalities meeting the following criteria at screening: Hemoglobin \< 90.0 g/L. Total white blood cell count \< 2.5 × 10⁹/L. Neutrophil count \< 1.5 × 10⁹/L. Lymphopenia (lymphocyte count \< 750...
- 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...
- Drug or alcohol abuse or dependence at screening, or history of drug or alcohol abuse or dependence within 6 months before randomization.
- Participation in any clinical trial of drugs or medical devices within 4 weeks or 5 half-lives (whichever is longer) before randomization.
- Blood donation ≥ 400 mL or receipt of blood transfusion within 3 months before randomization.
- Any other factors deemed by the investigator to potentially affect the conduct or result evaluation of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Beijing, Beijing Municipality, China
- Puyang, Henan, China
- Hohhot, Inner Mongolia, China
- Pingxiang, Jiangxi, China
- Linfen, Shanxi, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Beijing, Beijing Municipality, China; Puyang, Henan, China; Hohhot, Inner Mongolia, China; Pingxiang, Jiangxi, China; Linfen, Shanxi, China. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.