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

March 15, 2021 updated by: SecuraBio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
      • Plovdiv, Bulgaria
      • Ruse, Bulgaria
      • Sofia, Bulgaria
      • Stara Zagora, Bulgaria
      • Targovishte, Bulgaria
      • Varna, Bulgaria
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
    • Santander
      • Bucaramanga, Santander, Colombia
  • Germany
      • Frankfurt, Germany
      • Halle, Germany
  • Hungary
      • Budapest, Hungary
      • Kecskemet, Hungary
      • Mezokovesd, Hungary
      • Nyiregyhaza, Hungary
      • Veszprem, Hungary
  • Mexico
      • Mexico City, Mexico
    • Col Roam Sur
      • Mexico City, Col Roam Sur, Mexico
    • Del Cuautemoc
      • Mexico City, Del Cuautemoc, Mexico
    • Guanajuato
      • Leon, Guanajuato, Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
    • Mexico DF
      • Madero, Mexico DF, Mexico
    • Michoacan
      • Morelia, Michoacan, Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
    • San Luis Potosi, C.P.
      • San Luis Potosi, San Luis Potosi, C.P., Mexico
    • Yucatan
      • Merida, Yucatan, Mexico
  • New Zealand
      • Wellington, New Zealand
    • Auckland
      • Otahuhu, Auckland, New Zealand
  • Poland
      • Bialystok, Poland
      • Elblag, Poland
      • Krakow, Poland
      • Lublin, Poland
      • Nadarzyn, Poland
      • Poznan, Poland
      • Skierniewice, Poland
      • Sosnowiec, Poland
      • Stalowa Wola, Poland
      • Starachowice, Poland
      • Wroclaw, Poland
    • Mazowiecki
      • Grodzisk, Mazowiecki, Poland
    • Okulickiego
      • Kraków, Okulickiego, Poland
  • Romania
      • Baia Mare, Romania
      • Braila, Romania
      • Bucharest, Romania
      • Oradea, Romania
      • Timisoara, Romania
  • Russian Federation
      • Moscow, Russian Federation
      • Orenburg, Russian Federation
      • Saratov, Russian Federation
      • St. Petersburg, Russian Federation
      • Vladimir, Russian Federation
      • Yaroslavl, Russian Federation
    • Karelia
      • Petrozavodsk, Karelia, Russian Federation
    • Ryazanskaya Oblast
      • Ryazan, Ryazanskaya Oblast, Russian Federation
  • Serbia
      • Belgrade, Serbia
      • Novi Sad, Serbia
  • Ukraine
      • Donetsk, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Poltava, Ukraine
      • Ternopil, Ukraine
      • Zaporizhzhya, Ukraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo BID
Drug: Placebo
2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
EXPERIMENTAL: IPI-145, low dose BID
Drug: IPI-145
2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
EXPERIMENTAL: IPI-145, medium dose BID
Drug: IPI-145
2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
EXPERIMENTAL: IPI-145, high dose BID
Drug: IPI-145
2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SecuraBio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (ESTIMATE)

May 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-145-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on IPI-145

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe