NCT04004429

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

A Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: SynAct Pharma Aps · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The study will be conducted in two parts separated by an interim analysis. Part 1: The subjects will be randomized in a 1:1:1 ratio into: . * AP1189 dose 50 mg * AP1189 dose 100 mg * placebo INTERIM ANALYSIS Part 2: All subjects will be randomized into either design 1, 2 or 3 based on data from the interim analysis. * Design 1: AP1189 dose 50 mg or placebo in a 2:1 ratio * Design 2: AP1189 dose 100 mg or placebo in a 2:1 ratio * Design 3: Continue with the same doses as in Part 1 The purpose of this study is to determine the safety and efficacy of 2 doses of AP1189 compared with placebo after 4 weeks of treatment.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	50 mg AP1189	50 mg AP1189 powder in bottle
DRUG	AP1189	100 mg AP1189 powder in bottle
DRUG	Placebo	Placebo powder in bottle

Timeline

• Start date: 2019-08-26
• Primary completion: 2021-11-16
• Completion: 2021-11-16
• First posted: 2019-07-02
• Last updated: 2024-07-10
• Results posted: 2024-07-10

Locations

2 sites across 2 countries: Denmark, Norway