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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01851707

Acronym

ASPIRA

Enrollment

322

Registered

2013-05-10

Start date

2013-04-30

Completion date

2015-02-28

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief 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.

Interventions

DRUGIPI-145

2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.

DRUGPlacebo

2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Documented diagnosis of Rheumatoid Arthritis for at least 6 months * Active disease, based on Screening clinical and laboratory criteria, despite taking methotrexate for at least 3 months

Exclusion criteria

* Pregnant or lactating females * Previous failure or inadequate response to \>2 biologic disease-modifying anti-rheumatic drugs (DMARDs) * Concurrent DMARD treatment other than methotrexate, sulfasalazine, chloroquine, or hydroxychloroquine * Treatment with \> 10 mg daily prednisone (or equivalent) or more than one non-steroidal anti-inflammatory drug

Design outcomes

Primary

Measure	Time frame
Proportion of subjects who achieve a 20% improvement in the American College of Rheumatology Criteria (ACR20) from Baseline to Week 12	Baseline (Day 1), Weeks 2, 4, 6, 8, 10 and 12

Countries

Bulgaria, Colombia, Germany, Hungary, Mexico, New Zealand, Poland, Romania, Russia, Serbia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026