Phase 2B in RA patients with an inadequate response to methotrexate (finalized)
Only the first part of the study was conducted, providing results about the efficacy and safety of multiple doses of resomelagon combined with MTX over 4 weeks. Also, in this study resomelagon was safe and well tolerated.
Only a minority of the patients included in the study had a medical history of 3-6 months treatment with methotrexate and or short time from RA diagnosis to initiation of MTX. This significantly limited the ability to evaluate the potential of resomelagon as a treatment option in patients who did not response to first line treatment following initial 3-6 months treatment with MTX.
It was therefore decided not the continue to part B of the study, that was intended as a 12 week dose range phase 2b study in patients who did not response to first line treatment with MTX.
However, the study gave important information of safety showing similar incidence rates of treatment emergent Adverse events (TEAEs) across treatment groups (range: 21.4% to 34.4% across treatment groups). No statistically significant difference was observed between resomelagon and placebo in the primary efficacy endpoint (ACR20 response rate at week 4) and most secondary variable analyses.