drugset / Trial / NCT04004429

A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease

NCT04004429 ↗

Phase 2 Completed 105 enrolled SynAct Pharma Aps
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) \> 22, who are to start up-titration with methotrexate.

Timeline

Start
2019-08-26
Primary completion
2021-11-16
Completion
2021-11-16

Outcome

Met primary endpoint

release “AP1189 achieves primary endpoint and favorable safety profile in patients with Rheumatoid Arthritis with ongoing active joint disease in the Phase 2a study BEGIN.” synactpharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Resomelagon Small molecule 50 mg —
Subject Resomelagon Small molecule 100 mg —

Indications