Idiopathic Pulmonary FibrosisPhase 2NCT01266135
Safety and Efficacy of QAX576 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing QAX576 in people with Idiopathic Pulmonary Fibrosis, run by Novartis Pharmaceuticals at 10 sites in 2 countries.
Trial summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- QAX576
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Dec 2010to Apr 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF), based on an appropriate clinical definition of IPF as detailed in the ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management Diagnosis must be confirmed by a diagnostic HRCT or surgical lung biopsy.
- A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental oxygen allowed).
Who cannot join
- Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine levels in the range defined as 'smokers' per the local lab.
- Lung residual volume > 120% predicted at Screening.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Novartis Investigative Site
Boston, Massachusetts, 02115
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Gainesville, Florida, 32611
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
Orlando, Florida, 32803
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15219
Novartis Investigative Site
San Antonio, Texas, 78229
United Kingdom3 sites
Novartis Investigative Site
Cambridge, CB2 2QQ
Novartis Investigative Site
Leicester, LE3 9QP
Novartis Investigative Site
London, SW3 6PH
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF
This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- QAX576, Placebo
- Keywords
- Interstitial Lung Disease, Usual Interstitial Pneumonia, Fibrosis,, Pulmonary Fibrosis,, Respiratory Disease,, Interstitial Lung Disease,, Biological Therapy,, Therapeutic Uses,
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial, Fibrosis, Pulmonary Fibrosis, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAX576Drug
QAX576 10 mg/kg intravenous infusion
PlaceboDrug
Placebo to QAX576 intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: QAX576 10 mg/kg | Experimental | Not described Receives: Drug: QAX576 |
| Arm 2: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF
Measured: 1 year
Change in forced vital capacity (FVC) at 52 weeks as compared to baseline
Measure: FVC was measured using a spirometer according to American Thoracic Society / European Respiratory Society guidelines at screening and week 52 of the treatment period.
Measured: 1 year
Safety and tolerability of QAX576.
Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.
Measured: 1 year
Secondary outcomes (6)
To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy
Measured: 1 year
To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood
Measured: 1 year
Time to clinical worsening:
Measure: Time to clinical worsening defined as fall in FVC or Diffusing Capacity of the lung for Carbon Monoxide (DLco), lung transplant or lung disease (IPF)-related death
Measured: 1 year
Exacerbation of IPF
Measure: Incidence of exacerbation of IPF during the study
Measured: 1 year
Progression of fibrosis
Measure progression of fibrosis in the lungs as measured by Quantitative High Resolution Computerized Tomography (HRCT)
Measured: 1 year
Pharmacokinetics of QAX576
Measure concentrations of QAX576 and its metabolites in blood throughout the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266135
- Sponsor's protocol ID
- CQAX576A2203
- Other IDs
- 2010-020688-18
- Status last verified
- Apr 2015
- First submitted
- 17 Dec 2010
- Last updated
- 19 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multiple-dose, Exploratory Proof of Concept Study to Assess the Safety, Tolerability, Efficacy, Pharmacodynamic (PD) and Pharmacokinetics of QAX576 in Patients With Rapidly Progressive IPF
- ClinicalTrials.gov ID
- NCT01266135
- Acronym / sponsor ID
- CQAX576A2203
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Interstitial Lung Disease, Usual Interstitial Pneumonia, Fibrosis,, Pulmonary Fibrosis,, Respiratory Disease,, Interstitial Lung Disease,, Biological Therapy,, Therapeutic Uses,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Dec 2010 (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 study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: QAX576 10 mg/kg | Experimental | Drug: QAX576 |
| Arm 2: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF), based on an appropriate clinical definition of IPF as detailed in the ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management Diagnosis must be confirmed by a diagnostic HRCT or surgical lung biopsy.
- A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental oxygen allowed).
Key exclusion criteria (2 listed)
- Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine levels in the range defined as 'smokers' per the local lab.
- Lung residual volume > 120% predicted at Screening.
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 |
|---|---|---|
| QAX576QAX576 10 mg/kg intravenous infusion | Drug | Arm 1: QAX576 10 mg/kg |
| PlaceboPlacebo to QAX576 intravenous infusion | Drug | Arm 2: Placebo |
Primary outcome
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF
Time frame: 1 year
Change in forced vital capacity (FVC) at 52 weeks as compared to baseline
Time frame: 1 year
Measure: FVC was measured using a spirometer according to American Thoracic Society / European Respiratory Society guidelines at screening and week 52 of the treatment period.
Safety and tolerability of QAX576.
Time frame: 1 year
Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.
6 secondary outcomes
To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy
Time frame: 1 year
To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood
Time frame: 1 year
Time to clinical worsening:
Time frame: 1 year
Exacerbation of IPF
Time frame: 1 year
Progression of fibrosis
Time frame: 1 year
Pharmacokinetics of QAX576
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results for CQAX576A2203 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 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 QAX576 in people with Idiopathic Pulmonary Fibrosis, run by Novartis Pharmaceuticals at 10 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, 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 was stopped early. Results are not available in the source record.
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?
To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF (time frame: 1 year). The study lists 3 primary outcomes in all. 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 19 Dec 2020.