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

Sponsor

SecuraBio (Industry)

Overall Status

Completed

CT.gov ID

NCT01851707

Collaborator

(none)

322

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: IPI-145 Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

322 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.
Placebo Comparator: Placebo BID	Drug: Placebo 2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country
1	Pleven		Bulgaria
2	Plovdiv		Bulgaria
3	Ruse		Bulgaria
4	Sofia		Bulgaria
5	Stara Zagora		Bulgaria
6	Targovishte		Bulgaria
7	Varna		Bulgaria
8	Medellin	Antioquia	Colombia
9	Bogota	Cundinamarca	Colombia
10	Bucaramanga	Santander	Colombia
11	Frankfurt		Germany
12	Halle		Germany
13	Budapest		Hungary
14	Kecskemet		Hungary
15	Mezokovesd		Hungary
16	Nyiregyhaza		Hungary
17	Veszprem		Hungary
18	Mexico City	Col Roam Sur	Mexico
19	Mexico City	Del Cuautemoc	Mexico
20	Leon	Guanajuato	Mexico
21	Guadalajara	Jalisco	Mexico
22	Madero	Mexico DF	Mexico
23	Morelia	Michoacan	Mexico
24	Monterrey	Nuevo Leon	Mexico
25	San Luis Potosi	San Luis Potosi, C.P.	Mexico
26	Merida	Yucatan	Mexico
27	Mexico City		Mexico
28	Otahuhu	Auckland	New Zealand
29	Wellington		New Zealand
30	Grodzisk	Mazowiecki	Poland
31	Kraków	Okulickiego	Poland
32	Bialystok		Poland
33	Elblag		Poland
34	Krakow		Poland
35	Lublin		Poland
36	Nadarzyn		Poland
37	Poznan		Poland
38	Skierniewice		Poland
39	Sosnowiec		Poland
40	Stalowa Wola		Poland
41	Starachowice		Poland
42	Wroclaw		Poland
43	Baia Mare		Romania
44	Braila		Romania
45	Bucharest		Romania
46	Oradea		Romania
47	Timisoara		Romania
48	Petrozavodsk	Karelia	Russian Federation
49	Ryazan	Ryazanskaya Oblast	Russian Federation
50	Moscow		Russian Federation
51	Orenburg		Russian Federation
52	Saratov		Russian Federation
53	St. Petersburg		Russian Federation
54	Vladimir		Russian Federation
55	Yaroslavl		Russian Federation
56	Belgrade		Serbia
57	Novi Sad		Serbia
58	Donetsk		Ukraine
59	Kharkiv		Ukraine
60	Kyiv		Ukraine
61	Lviv		Ukraine
62	Poltava		Ukraine
63	Ternopil		Ukraine
64	Zaporizhzhya		Ukraine

Sponsors and Collaborators

SecuraBio

Investigators

Study Chair: Hagop Youssoufian, MD, Verastem, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SecuraBio

ClinicalTrials.gov Identifier:

NCT01851707

Other Study ID Numbers:

IPI-145-04

First Posted:

May 10, 2013

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Mar 17, 2021