NCT02387762

ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate

A Phase 2a, 4-Week, Double-Blind, Proof-of-Concept Efficacy and Safety Study of ACP-196 Versus Placebo in Subjects With Active Rheumatoid Arthritis on Background Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.

Detailed description

A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	acalabrutinib
DRUG	Placebo

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2015-03-13
• Last updated: 2019-04-02
• Results posted: 2019-03-26

Locations

17 sites across 1 country: United States