A double-blind, placebo-controlled, randomized multiple dose phase 1b trial of a CDK4/6 inhibitor, TCK-276, in patients with active rheumatoid arthritis
Authors' conclusion
TCK-276 (≤175 mg) was well tolerated with no clinically meaningful safety signals in patients with active RA.
Study context
- Population
- Patients with active RA4 cohorts of 8 (6 active, 2 placebo)
- Participants
- 32 patients
- Comparison
- TCK-276 10, 25, 75 or 175 mg/day orally once daily for 7 days vs matching placebo
- Primary endpoint
- Safety, tolerability and pharmacokinetics of TCK-276 (efficacy exploratory)
Methodological detailsphase 1b, multicentre, double-blind, placebo-controlled, dose-ascending, multiple-dose
- Phase 1b
- Multicentre
- Double-blind
- Placebo-controlled
- Dose-ascending
- Multiple-dose
Primary result
As reported in the abstract
Safety and pharmacokinetics
- No deaths, serious adverse events, clinically meaningful laboratory (incl. haematological), vital sign, ECG or cardiac telemetry changes
- TCK-276 rapidly absorbed; half-life ≈6 to 12 h
- No obvious accumulation; increase in exposure dose proportional
Further findings
DAS28-CRP response (EULAR good or moderate), exploratory · day 7
| Outcome | 25 mg/day | 75 mg/day | 175 mg/day | Placebo |
|---|---|---|---|---|
| ACR20 response, exploratory · day 7 | 33.3% | 60% | 50% | 0 events |
- DAS28-CRP response (EULAR good or moderate), exploratory: 10 mg/day result not reported
- ACR20 response, exploratory: 10 mg/day result not reported
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
A double-blind, placebo-controlled, randomized multiple dose phase 1b trial of a CDK4/6 inhibitor, TCK-276, in patients with active rheumatoid arthritis. Rheumatology (Oxford). Published 13 July 2024. doi:10.
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