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

NCT07408024 | Recruiting Phase 2

• 2 other identifiers: TLBT-TOLLB-001-IIaCTR20253314
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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) .

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• Safety-AE/lab tests/PE/VS/ECG

  Safety parameters including the incidence of adverse events (AEs), abnormalities in laboratory tests, physical examinations, vital signs, and routine 12-lead electrocardiograms

  up to week 8

Study Arms (4)

TollB-001 Low Dose

EXPERIMENTAL

Drug: TollB-001

TollB-001 Intermediate dose

EXPERIMENTAL

Drug: TollB-001

TollB-001 High dose

EXPERIMENTAL

Drug: TollB-001

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Placebo Tablets

Placebo

TollB-001 DRUG

TollB-001 Tablets

TollB-001 High dose; TollB-001 Intermediate dose; TollB-001 Low Dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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) classification criteria.
• DAS28-CRP \> 3.2 at screening.
• 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 with inadequate response or intolerance, and agrees to discontinue use during the study.
• 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.
• 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).

You may not qualify if:

• Hypersensitivity to the study drug or any of its components.
• ACR functional class IV or being bedridden/wheelchair-bound for a long time.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Toll Biotech Co. Ltd. (Beijing): lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 102206, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Weili Wang

CONTACT

+86 10 80710966; wangweili@toll-biotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 12, 2026
• Study Start: September 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)