NCT01851707

A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of Duvelisib With Background Methotrexate in Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: SecuraBio · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and efficacy of multiple dose levels of the investigational product (study drug), IPI-145, in combination with methotrexate compared to methotrexate alone in subjects with active moderate-to-severe Rheumatoid Arthritis.

Detailed description

This Phase 2 study is designed to examine the efficacy and safety of multiple dose levels of IPI-145 in subjects with active moderate-to-severe Rheumatoid Arthritis receiving a background stable dose of methotrexate. The study will employ a randomized, double-blind, placebo-controlled, parallel design. Approximately 316 adult subjects who meet all eligibility criteria at Screening will be randomized at Baseline in a 1:1:1:1 ratio to one of 4 dose groups. All treatments will be administered twice a day (BID). After randomization, subjects will enter a 12-week Treatment Period, where study drug (IPI-145 or placebo) will be self-administered BID as an outpatient. During the Treatment Period, subjects will return to the clinic for efficacy and safety assessments every 2 weeks. Following Treatment Period completion at Week 12, subjects will enter a 3-week Follow-up Period which includes one clinic visit approximately 3 weeks after the last dose of study drug.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	IPI-145	2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
DRUG	Placebo	2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-12-01
• Completion: 2015-02-01
• First posted: 2013-05-10
• Last updated: 2021-03-17

Locations

64 sites across 11 countries: Bulgaria, Colombia, Germany, Hungary, Mexico, New Zealand, Poland, Romania, Russia, Serbia, Ukraine