Dual janus kinase (JAK) and ROCK inhibition with CPL'116 in patients with rheumatoid arthritis with inadequate response to methotrexate: a randomised, double-blind, placebo-controlled, phase 2 trial
Authors' conclusion
The findings of this study suggest a dose-dependent response with CPL'116, with significant efficacy at the high dose of 240 mg twice daily.
Study context
- Population
- Patients aged 18–75 years with moderate-to-severe RA for ≥6 months and inadequate response to MTX, nine hospitals or clinics in Poland and Ukraine79 (75%) women
- Participants
- 106 patients
- Comparison
- Oral CPL'116 60 mg, 120 mg or 240 mg vs placebo twice daily for 12 weeks, with background MTX
- Primary endpoint
- Change from baseline in DAS28-CRP
- Follow-up
- Week 12
Methodological detailsphase 2, double-blind, dose-ranging, placebo-controlled, parallel-group, multicentre
- Phase 2
- Double-blind
- Dose-ranging
- Placebo-controlled
- Parallel-group
- Multicentre
Primary result
As reported in the abstract
Least squares mean difference (95% CI)P value
CPL'116 60 mgvs Placebo
−0.15(−0.81 to 0.52)
P = 0.67120 mgvs Placebo
−0.56(−1.25 to 0.12)
P = 0.10240 mgvs Placebo
−0.89(−1.56 to −0.22)
P = 0.010Safety
| Outcome | Values |
|---|---|
| Serious treatment-emergent adverse events (both led to discontinuation) | CPL'116 60 mg 1 events · 240 mg 1 events |
| Discontinuation due to leukopenia (possibly related) | 240 mg 1 events |
- Serious treatment-emergent adverse events (both led to discontinuation): 60 mg: non-fatal NSTEMI, possibly related
- Serious treatment-emergent adverse events (both led to discontinuation): 240 mg: non-muscle invasive bladder cancer, unrelated
Severe adverse events, deaths, laboratory or haematology abnormalities
- No severe adverse events or deaths were reported
- No laboratory or haematology abnormalities were recorded at any CPL'116 dose
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Dual JAK and ROCK inhibition with CPL'116 in patients with rheumatoid arthritis with inadequate response to methotrexate: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Rheumatol. Published 11 June 2025. doi:10.
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