Clinical trial NCT01851707: A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2013-05-10
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects who achieve a 20% improvement in the American College of Rheumatology Criteria (ACR20) from Baseline to Week 12
timeFrame: Baseline (Day 1), Weeks 2, 4, 6, 8, 10 and 12
Secondary outcomes:
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Targovishte
country: Bulgaria
city: Varna
country: Bulgaria
city: Medellin
country: Colombia
state: Antioquia
city: Bogota
country: Colombia
state: Cundinamarca
city: Bucaramanga
country: Colombia
state: Santander
city: Frankfurt
country: Germany
city: Halle
country: Germany
city: Budapest
country: Hungary
city: Kecskemet
country: Hungary
city: Mezokovesd
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Veszprem
country: Hungary
city: Mexico City
country: Mexico
state: Col Roam Sur
city: Mexico City
country: Mexico
state: Del Cuautemoc
city: Leon
country: Mexico
state: Guanajuato
city: Guadalajara
country: Mexico
state: Jalisco
city: Madero
country: Mexico
state: Mexico DF
city: Morelia
country: Mexico
state: Michoacan
city: Monterrey
country: Mexico
state: Nuevo Leon
city: San Luis Potosi
country: Mexico
state: San Luis Potosi, C.P.
city: Merida
country: Mexico
state: Yucatan
city: Mexico City
country: Mexico
city: Otahuhu
country: New Zealand
state: Auckland
city: Wellington
country: New Zealand
city: Grodzisk
country: Poland
state: Mazowiecki
city: Kraków
country: Poland
state: Okulickiego
city: Bialystok
country: Poland
city: Elblag
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Nadarzyn
country: Poland
city: Poznan
country: Poland
city: Skierniewice
country: Poland
city: Sosnowiec
country: Poland
city: Stalowa Wola
country: Poland
city: Starachowice
country: Poland
city: Wroclaw
country: Poland
city: Baia Mare
country: Romania
city: Braila
country: Romania
city: Bucharest
country: Romania
city: Oradea
country: Romania
city: Timisoara
country: Romania
city: Petrozavodsk
country: Russian Federation
state: Karelia
city: Ryazan
country: Russian Federation
state: Ryazanskaya Oblast
city: Moscow
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Vladimir
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Novi Sad
country: Serbia
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Poltava
country: Ukraine
city: Ternopil
country: Ukraine
city: Zaporizhzhya
country: Ukraine
Study officials:
affiliation: Verastem, Inc.
name: Hagop Youssoufian, MD
role: STUDY_CHAIR
References: