SynAct-CS003
The SynAct-CS003 study is an explorative, double-blind, multi-center, randomized, placebo-controlled study of safety, tolerability, pharmacokinetics, and efficacy of treatment with resomelagon (AP1189) in patients with idiophathic membranous nephropathy (iMN).
The study is designed to test safety tolerability and efficacy of resomelagon (AP1189) vs. placebo given as an add on to ACE inhibitor or angiotensin II receptor blocker treatment.
The study is planned to enroll 23 patients (minimum of 18 patients) who are treated with 100 mg resomelagon (AP1189) or placebo in a 2:1 randomization.
Status: Recruiting.
For further information on the study setup see clinicaltrials.gov
SynAct-CS007 (EXPAND)
The SynAct-CS007 study is a study to assess the safety & efficacy of treatment with resomelagon (AP1189) in Rheumatoid Arthritis patients naïve to DMARD treatment (EXPAND).
The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks expanded daily treatment with 100 mg resomelagon (AP1189) in RA patients who are to start up-titration with methotrexate (MTX).
Status: Recruiting.
For further information on the study setup see clinicaltrials.gov
SynAct-CS006 (RESOLVE)
A Dose-range study of the safety and efficacy of treatment in adult rheumatoid arthritis patients experiencing an inadequate response to methotrexate.
The RESOLVE study is a two-part, randomized, double-blind, multi-center, placebo-controlled study of the safety, dose-range finding confirmation, and efficacy of 4 (Part A) and 12 weeks (Part B) of treatment with resomelagon (AP1189) in adult RA patients with an inadequate response to MTX alone.
Status: Recruiting.
For further information on the study setup see clinicaltrials.gov.