Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT02538536
A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing PBI4050 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Liminal BioSciences Ltd. at 5 sites in Canada.
Trial summary
This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in 40 adult patients with IPF. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- PBI4050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 5 sitesCanada
- Study dates
- Jul 2015to Jan 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is an adult aged 40 years or older
- Patient has signed written informed consent.
- Patient has been diagnosed of IPF according to the most recent guideline on IPF diagnosis and management released by American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Association (ALAT).
- Female patients of childbearing potential must have a negative urine pregnancy test and agree to use adequate birth control from screening throughout the study and for 30 days after the last study drug administration.
- If a male patient has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the last study drug administration.
Who cannot join
- Patient has a known diagnosis of a respiratory disorder other than IPF.
- Substantial emphysema on high resolution computer tomography (HRCT) with degree of emphysema greater than fibrosis.
- Patient is an active smoker.
- Patient has evidence of active infection.
- Patients currently has or has a history of cancer, except basal cell carcinoma or squamous cell carcinoma of the skin.
- Patient has a concurrent medical or psychological condition that, in the investigator's opinion, may compromise the patient's ability to participate in the study or give informed consent, or may complicate the evaluations of the study drug.
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- Patient is receiving another investigational treatment for IPF at screening and/or plans to receive an investigational treatment for IPF during the current study.
- Patient has chronic hepatitis or significantly elevated liver enzyme levels, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × upper limit of normal (ULN) or total bilirubin above ULN.
- Female patient who is pregnant, breast-feeding, or planning a pregnancy during the course of the study.
- Woman of childbearing potential who is unwilling to use adequate birth control throughout the duration of the study.
- Patient has participated in an investigational clinical trial during the last 4 weeks.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Study site
Halifax, Nova Scotia
Study site
Montreal, Quebec
Study site
Sherbrooke, Quebec
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
About this study
Official title: A Phase 2, Open-label, Single Arm, Exploratory, Observational Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in 40 adult patients with IPF.
Read the detailed description
This Phase 2 multi-centre study will be performed by 6 Canadian sites. It is an open-label, single-arm study in patients with Idiopathic Pulmonary Fibrosis (IPF) aged 40 years and older.
The duration of study participation is approximately 20 weeks for each patient and comprises 6 study visits.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- PBI4050
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBI4050Drug
| Study group | Role | What they receive |
|---|---|---|
| PBI4050 | Experimental | Four 200 mg capsules (total 800 mg) administered orally, once daily. Receives: Drug: PBI4050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
Measured: 4 months
Secondary outcomes (3)
Change from baseline on pulmonary function tests
Measured: 3 months
Change from baseline in imaging of thorax
Measured: 3 months
Change from baseline on biomarkers
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liminal BioSciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538536
- Sponsor's protocol ID
- PBI-4050-ATX-9-03
- Status last verified
- Apr 2019
- First submitted
- 25 Aug 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Single Arm, Exploratory, Observational Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT02538536
- Acronym / sponsor ID
- PBI-4050-ATX-9-03
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Liminal BioSciences Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Sep 2015 (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.
This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in 40 adult patients with IPF.
Detailed description
This Phase 2 multi-centre study will be performed by 6 Canadian sites. It is an open-label, single-arm study in patients with Idiopathic Pulmonary Fibrosis (IPF) aged 40 years and older.
The duration of study participation is approximately 20 weeks for each patient and comprises 6 study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PBI4050 | Experimental | Drug: PBI4050Four 200 mg capsules (total 800 mg) administered orally, once daily. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is an adult aged 40 years or older
- Patient has signed written informed consent.
- Patient has been diagnosed of IPF according to the most recent guideline on IPF diagnosis and management released by American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Association (ALAT).
- Female patients of childbearing potential must have a negative urine pregnancy test and agree to use adequate birth control from screening throughout the study and for 30 days after the last study drug administration.
- If a male patient has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the last study drug administration.
Key exclusion criteria (11 listed)
- Patient has a known diagnosis of a respiratory disorder other than IPF.
- Substantial emphysema on high resolution computer tomography (HRCT) with degree of emphysema greater than fibrosis.
- Patient is an active smoker.
- Patient has evidence of active infection.
- Patients currently has or has a history of cancer, except basal cell carcinoma or squamous cell carcinoma of the skin.
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 |
|---|---|---|
| PBI4050 | Drug | PBI4050 |
Primary outcome
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
Time frame: 4 months
3 secondary outcomes
Change from baseline on pulmonary function tests
Time frame: 3 months
Change from baseline in imaging of thorax
Time frame: 3 months
Change from baseline on biomarkers
Time frame: 3 months
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 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PBI4050 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Liminal BioSciences Ltd. at 5 sites in Canada.
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 5 inclusion and 11 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 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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. 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?
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment (time frame: 4 months). 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 Apr 2019.