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NCT07408024
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
Phase 2 trial testing Group 1: TollB-001 100mg qd po; Group 2: TollB-001 200mg qd po; Group 3: TollB-001400mg qd po in Rheumatoid Arthritis (RA) in 24 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | Toll Biotech Co. Ltd. (Beijing) |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 10 September 2025 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 6 locations across China |
Drugs / interventions tested
- Group 1: TollB-001 100mg qd po; Group 2: TollB-001 200mg qd po; Group 3: TollB-001400mg qd po — full drug profile →
- Placebo
Conditions studied
- Rheumatoid Arthritis (RA) — all drugs for Rheumatoid Arthritis (RA) →
Sponsor
Toll Biotech Co. Ltd. (Beijing) — full company profile →
Who can join
Adults 18 to 70, any sex, with Rheumatoid Arthritis (RA). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07408024
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rheumatoid Arthritis (RA)
Currently open trials in the same condition.
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- NCT07438652 — Effect of Mediterranean vs Paleolithic Diet on RA Activity, Sarcopenia and QOL: 12-Week RCT · NA · recruiting
- NCT07264101 — Validity And Reliability Of The Four Square Step Test In Individuals With Rheumatoid Arthritis · recruiting
- NCT07221890 — A Trial of Academic Detailing to Promote Prescribing of Biosimilars · NA · active not recruiting
- NCT07100873 — A Phase 1 Study of ADI-001 in Rheumatoid Arthritis · Phase 1 · recruiting
Other Toll Biotech Co. Ltd. (Beijing) trials
Trials by the same sponsor.
- NCT06103773 — A Study of Single and Multiple Oral Doses of TollB-001 · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07408024 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Toll Biotech Co. Ltd. (Beijing)
- Last refreshed: 12 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07408024.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing