Ongoing clinical studies

AP1189-CS002

The AP1189-CS002 study is a double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease.

The study is designed to test safety tolerability and efficacy of AP1189 vs Placebo given as add on treatment to methotrexate (MTX) in previous MTX naïve RA patients.

The study is set up in a part 1 where two doses of AP1189 is tested vs placebo in a total of 36 patients and in a part 2 where additional 54 patients is treated with AP1189 or Placebo in a 2:1 randomization.

The study has completed dosing and reporting of key results are planned to happen by end of November 2021.

For further information on the study setup see clinicaltrials.gov.

SynAct-CS003

The SynAct-CS003 study is a double-blind, multi-center, randomized, placebo-controlled study of safety, tolerability, pharmacokinetics, and efficacy of 4 weeks of treatment with AP1189 in patients with idiophathic membranous nephropathy (iMN).

The study is designed to test safety tolerability and efficacy of 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 AP1189 or placebo in a 2:1 randomization.

For further information on the study setup see clinicaltrials.gov.

SynAct-CS004

The SynAct-CS004 study is a single center, open label, 3-part pharmacokinetic study, with 12 healthy subjects in each part. The primary objective of the first part is to determine the relative bioavailability of AP1189 after dosing with the newly developed tablets versus the oral suspension used so far in clinical trials. The first part will deliver key results already in November 2021.

In the second and third part of the study, the food effect on the pharmacokinetics, which is a regulatory requirement, and proportionality following dosing at different dose levels will be evaluated.

The study is planned to complete dosing and reporting of results for the second and third parts during the spring of 2022.