AsthmaPhase 2NCT01653756
A Phase 2a, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects
A Phase 2 study testing IPI-145, a PI3K Inhibitor in people with Asthma, run by SecuraBio at 4 sites in 2 countries.
Trial summary
The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung function in mild asthmatic subjects following allergen challenge. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- IPI-145, a PI3K Inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2012to Sep 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adults between 18 and 60 years of age
- Diagnosis of asthma (mild) for at least 6 months prior to Screening
- Forced expiratory volume in one second (FEV1) ≥70% of predicted value at Screening
- A positive skin prick test to test allergen
Who cannot join
- Any prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor other than IPI-145 in a previous clinical study
- Acute asthma exacerbations within 6 weeks prior to Screening
- Use of any medication for the treatment of asthma other than a short-acting β2 agonist (as needed) within the 4 weeks prior to Screening
- Participation in another clinical study within minimum of 30 days prior to study Screening
- A positive screen result for active or latent tuberculosis
- A history of cardiovascular disease
Show all 9Show fewer
- The concomitant use of acid-reducing agents and cholinesterase inhibiting medication
- Inadequate hepatic function defined by Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) greater than 1.5 times greater limit of normal (ULN)
- Inadequate renal function defined by serum creatinine greater than 2.0 milligrams/dL
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Investigational Site
Berlin
Investigational Site
Großhansdorf
Investigational Site
Wiesbaden
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose, Cross-Over, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects Undergoing Allergen Challenge
The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung function in mild asthmatic subjects following allergen challenge.
Read the detailed description
This is a phase 2a, randomized, double-blind, placebo-controlled, multi-dose, 2-way cross-over study designed to examine the effect of IPI-145 on lung function and inflammatory indices in mild, allergen-reactive asthmatic subjects undergoing allergen challenge.
- Conditions
- Asthma
- Being tested
- IPI-145, a PI3K Inhibitor, Placebo to match IPI-145
- Keywords
- Asthma, Allergen Challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-145, a PI3K InhibitorDrug
Active drug
Placebo to match IPI-145Drug
Comparator
| Study group | Role | What they receive |
|---|---|---|
| IPI-145 | Active comparator | Capsules Receives: Drug: IPI-145, a PI3K Inhibitor; Drug: Placebo to match IPI-145 |
| Placebo | Placebo comparator | Capsules Receives: Drug: IPI-145, a PI3K Inhibitor; Drug: Placebo to match IPI-145 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in one second (FEV1)
Measured: Day 14
Secondary outcomes (3)
Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose
Measured: Day 14
Number of Participants with Adverse Events as a Measure of Safety
Measured: From signing of informed consent through 21 days following study drug administration
Change in C-reactive Protein (CRP) levels
Measured: Screening and/or Day 1 of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 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
- NCT01653756
- Sponsor's protocol ID
- IPI-145-03
- Other IDs
- 2012-001729-28
- Status last verified
- Mar 2021
- First submitted
- 19 Jul 2012
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
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 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose, Cross-Over, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects Undergoing Allergen Challenge
- ClinicalTrials.gov ID
- NCT01653756
- Acronym / sponsor ID
- IPI-145-03
- Conditions
- Asthma
- Keywords
- Asthma, Allergen Challenge
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Jul 2012 (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 examine the effects of multi-dose regimens of IPI-145 on lung function in mild asthmatic subjects following allergen challenge.
Detailed description
This is a phase 2a, randomized, double-blind, placebo-controlled, multi-dose, 2-way cross-over study designed to examine the effect of IPI-145 on lung function and inflammatory indices in mild, allergen-reactive asthmatic subjects undergoing allergen challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPI-145 | Active comparator | Drug: IPI-145, a PI3K Inhibitor, Drug: Placebo to match IPI-145Capsules |
| Placebo | Placebo comparator | Drug: IPI-145, a PI3K Inhibitor, Drug: Placebo to match IPI-145Capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female adults between 18 and 60 years of age
- Diagnosis of asthma (mild) for at least 6 months prior to Screening
- Forced expiratory volume in one second (FEV1) ≥70% of predicted value at Screening
- A positive skin prick test to test allergen
Key exclusion criteria (9 listed)
- Any prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor other than IPI-145 in a previous clinical study
- Acute asthma exacerbations within 6 weeks prior to Screening
- Use of any medication for the treatment of asthma other than a short-acting β2 agonist (as needed) within the 4 weeks prior to Screening
- Participation in another clinical study within minimum of 30 days prior to study Screening
- A positive screen result for active or latent tuberculosis
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-145, a PI3K InhibitorActive drug | Drug | IPI-145, Placebo |
| Placebo to match IPI-145Comparator | Drug | IPI-145, Placebo |
Primary outcome
Forced Expiratory Volume in one second (FEV1)
Time frame: Day 14
3 secondary outcomes
Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose
Time frame: Day 14
Number of Participants with Adverse Events as a Measure of Safety
Time frame: From signing of informed consent through 21 days following study drug administration
Change in C-reactive Protein (CRP) levels
Time frame: Screening and/or Day 1 of each treatment period
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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPI-145, a PI3K Inhibitor in people with Asthma, run by SecuraBio at 4 sites in 2 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 4 inclusion and 9 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 4 sites in Germany, United Kingdom. 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?
Forced Expiratory Volume in one second (FEV1) (time frame: Day 14). 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.