Rheumatoid Arthritis (RA)Phase 2NCT07408024
Safety and Efficacy of TollB-001 Tablets in Moderate to Severe Rheumatoid Arthritis
A Phase 2 study testing TollB-001 in people with Rheumatoid Arthritis (RA), run by Toll Biotech Co. Ltd. (Beijing) at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- TollB-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 102206
Xiaofeng Zeng, not provide, zengxfpumc@163.com
About this study
Official title: 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
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)
- Being tested
- TollB-001, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TollB-001Drug
TollB-001 Tablets
PlaceboDrug
Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| TollB-001 Low Dose | Experimental | Not described Receives: Drug: TollB-001 |
| TollB-001 Intermediate dose | Experimental | Not described Receives: Drug: TollB-001 |
| TollB-001 High dose | Experimental | Not described Receives: Drug: TollB-001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start10 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toll Biotech Co. Ltd. (Beijing)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408024
- Sponsor's protocol ID
- TLBT-TOLLB-001-IIa
- Other IDs
- CTR20253314
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07408024
- Acronym / sponsor ID
- TLBT-TOLLB-001-IIa
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Toll Biotech Co. Ltd. (Beijing)Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TollB-001TollB-001 Tablets | Drug | TollB-001 High dose, TollB-001 Intermediate dose, TollB-001 Low Dose |
| PlaceboPlacebo Tablets | Drug | Placebo |
Primary outcome
Safety-AE/lab tests/PE/VS/ECG
Time frame: up to week 8
Safety parameters including the incidence of adverse events (AEs), abnormalities in laboratory tests, physical examinations, vital signs, and routine 12-lead electrocardiograms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TollB-001 in people with Rheumatoid Arthritis (RA), run by Toll Biotech Co. Ltd. (Beijing) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Wang (+86 10 80710966, wangweili@toll-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety-AE/lab tests/PE/VS/ECG (time frame: up to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.