Rheumatoid ArthritisPhase 2ASPIRANCT01851707
A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone
A Phase 2 study testing IPI-145 in people with Rheumatoid Arthritis, run by SecuraBio at 64 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- IPI-145
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 64 sitesin 11 countries
- Study dates
- Apr 2013to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
64 sites in 11 countries.
64 sites in 11 countries
Poland13 sites
Study site
Bialystok
Study site
Elblag
Study site
Grodzisk, Mazowiecki
Study site
Krakow, Okulickiego
Study site
Krakow
Study site
Lublin
Study site
Nadarzyn
Study site
Poznan
Study site
Skierniewice
Study site
Sosnowiec
Study site
Stalowa Wola
Study site
Starachowice
Study site
Wroclaw
Mexico10 sites
Study site
Guadalajara, Jalisco
Study site
León, Guanajuato
Study site
Madero, Mexico DF
Study site
Mérida, Yucatán
Study site
Mexico City, Col Roam Sur
Study site
Mexico City, Del Cuautemoc
Study site
Mexico City
Study site
Monterrey, Nuevo León
Study site
Morelia, Michoacán
Study site
San Luis Potosí City, San Luis Potosi, C.P.
Russia8 sites
Study site
Moscow
Study site
Orenburg
Study site
Petrozavodsk, Republic of Karelia
Study site
Ryazan, Ryazan Oblast
Study site
Saint Petersburg
Study site
Saratov
Study site
Vladimir
Study site
Yaroslavl
Bulgaria7 sites
Study site
Pleven
Study site
Plovdiv
Study site
Rousse
Study site
Sofia
Study site
Stara Zagora
Study site
Targovishte
Study site
Varna
Ukraine7 sites
Study site
Donetsk
Study site
Kharkiv
Study site
Kyiv
Study site
Lviv
Study site
Poltava
Study site
Ternopil
Study site
Zaporizhzhya
Hungary5 sites
Study site
Budapest
Study site
Kecskemét
Study site
Mezőkövesd
Study site
Nyíregyháza
Study site
Veszprém
Romania5 sites
Study site
Baia Mare
Study site
Brăila
Study site
Bucharest
Study site
Oradea
Study site
Timișoara
Colombia3 sites
Study site
Bogota, Cundinamarca
Study site
Bucaramanga, Santander Department
Study site
Medellín, Antioquia
About this study
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
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.
Read the 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
- Being tested
- IPI-145, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-145Drug
2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
PlaceboDrug
2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IPI-145, low dose BID | Experimental | Not described Receives: Drug: IPI-145 |
| IPI-145, medium dose BID | Experimental | Not described Receives: Drug: IPI-145 |
| IPI-145, high dose BID | Experimental | Not described Receives: Drug: IPI-145 |
| Placebo BID | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve a 20% improvement in the American College of Rheumatology Criteria (ACR20) from Baseline to Week 12
Measured: Baseline (Day 1), Weeks 2, 4, 6, 8, 10 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- SecuraBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hagop Youssoufian, MD, Study chair, Verastem, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851707
- Sponsor's protocol ID
- IPI-145-04
- Acronym
- ASPIRA
- Status last verified
- Mar 2021
- First submitted
- 8 May 2013
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01851707
- Acronym / sponsor ID
- ASPIRA / IPI-145-04
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IPI-145, low dose BID | Experimental | Drug: IPI-145 |
| IPI-145, medium dose BID | Experimental | Drug: IPI-145 |
| IPI-145, high dose BID | Experimental | Drug: IPI-145 |
| Placebo BID | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPI-1452 blinded capsules will be administered twice a day (morning and night) for 12 weeks. | Drug | IPI-145, high dose BID, IPI-145, low dose BID, IPI-145, medium dose BID |
| Placebo2 blinded capsules will be administered twice a day (morning and night) for 12 weeks. | Drug | Placebo BID |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hagop Youssoufian, MD study chair
Verastem, Inc.
64 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPI-145 in people with Rheumatoid Arthritis, run by SecuraBio at 64 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in Poland, Mexico, Russia, Bulgaria, Ukraine and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.