Pulmonary Fibrosis Secondary to Systemic SclerosisPhase 2NCT00581997
QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis
A Phase 2 study testing QAX576 in people with Pulmonary Fibrosis Secondary to Systemic Sclerosis, run by Novartis Pharmaceuticals.
Trial summary
This study will evaluate the safety, tolerability, and mechanism of action of multiple doses of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Fibrosis Secondary to Systemic Sclerosis
- What is being tested?
- QAX576
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Apr 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 18 and 65 years with a confirmed diagnosis of pulmonary fibrosis secondary to systemic sclerosis
- Both men and women must be willing to use two forms of contraception. Additional information regarding this requirement is available at screening
Who cannot join
- Certain medical conditions may exclude patients from participation.
- Should not have participated in another clinical study within 4 weeks of study start
- Smokers are not eligible for participation
- Blood loss of donation of 400 mL or more within 2 months of study start
- Pregnant women or women who are breast feeding
- Past medical history of clinically significant ECG abnormalities
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- Connective tissue disorders other than systemic sclerosis.
- Active infection or history of systemic parasitic infection
- History of immunodeficiency diseases, including a positive HIV test result
- History of drug or alcohol abuse within 12 months of study start
- Any condition that may compromise patient safety
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: A Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System Sclerosis
This study will evaluate the safety, tolerability, and mechanism of action of multiple doses of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis
- Being tested
- QAX576, Placebo
- Keywords
- Pulmonary fibrosis, systemic sclerosis
- Medical subject headings
- Pulmonary Fibrosis, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAX576Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | QAX576 Receives: Drug: QAX576 |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Safety assessments including vital Signs, ECG's, Echocardiograms and blood draws. - The pharmacokinetics and pharmacodynamics of multiple doses of the drug will be assessed by blood draws at the 3 dosing visits. A blood sample will also be collected.
Measured: throughout the study
Secondary outcomes (1)
- The effect of the drug on biomarkers of pulmonary fibrosis and systemic sclerosis. - Pulmonary function tests. - Disease specific measurements, active hand extension, oral aperture, MRSS.
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionApr 2009
Why it stopped: Concerns about risk of bronchoscopy procedure in the selected patient population and frequency of SAEs observed to date.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Fibrosis Secondary to Systemic SclerosisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Principal investigator, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581997
- Sponsor's protocol ID
- CQAX576A2201
- Status last verified
- May 2012
- First submitted
- 21 Dec 2007
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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
- A Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System Sclerosis
- ClinicalTrials.gov ID
- NCT00581997
- Acronym / sponsor ID
- CQAX576A2201
- Keywords
- Pulmonary fibrosis, systemic sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Concerns about risk of bronchoscopy procedure in the selected patient population and frequency of SAEs observed to date.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Apr 2009 (actual)
- First posted
- 28 Dec 2007 (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 will evaluate the safety, tolerability, and mechanism of action of multiple doses of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: QAX576QAX576 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women between the ages of 18 and 65 years with a confirmed diagnosis of pulmonary fibrosis secondary to systemic sclerosis
- Both men and women must be willing to use two forms of contraception. Additional information regarding this requirement is available at screening
Key exclusion criteria (12 listed)
- Certain medical conditions may exclude patients from participation.
- Should not have participated in another clinical study within 4 weeks of study start
- Smokers are not eligible for participation
- Blood loss of donation of 400 mL or more within 2 months of study start
- Pregnant women or women who are breast feeding
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 |
|---|---|---|
| QAX576 | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
- Safety assessments including vital Signs, ECG's, Echocardiograms and blood draws. - The pharmacokinetics and pharmacodynamics of multiple doses of the drug will be assessed by blood draws at the 3 dosing visits. A blood sample will also be collected.
Time frame: throughout the study
1 secondary outcome
- The effect of the drug on biomarkers of pulmonary fibrosis and systemic sclerosis. - Pulmonary function tests. - Disease specific measurements, active hand extension, oral aperture, MRSS.
Time frame: throughout the study
Results and safety
The study was stopped early (reason given: Concerns about risk of bronchoscopy procedure in the selected patient population and frequency of SAEs observed to date.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results for CQAX576A2201 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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 principal investigator
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QAX576 in people with Pulmonary Fibrosis Secondary to Systemic Sclerosis, run by Novartis Pharmaceuticals.
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 12 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.
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 (reason given: Concerns about risk of bronchoscopy procedure in the selected patient population and frequency of SAEs observed to date.). 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?
- Safety assessments including vital Signs, ECG's, Echocardiograms and blood draws. - The pharmacokinetics and pharmacodynamics of multiple doses of the drug will be assessed by blood draws at the 3 dosing visits. A blood sample will also be collected. (time frame: throughout the study). 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.