To navigate the following site navigation expect to utilize the tab key to move through items sequentially. The spacebar or enter keys can be utilized to interact with items that open sub-navigation.
When autocomplete results are available use up and down arrows to review and enter to select.
Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Study Purpose
The study will evaluate the efficacy and safety of axatilimab in participants with IPF.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Key
Inclusion Criteria:
- Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European
Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic
Society Clinical Practice Guideline (Raghu 2018).
- Chest high-resolution computed tomography (HRCT) performed within 12 months prior to
first Screening Visit and according to the minimum requirements for IPF diagnosis by
central review based on participant's HRCT only (if no lung biopsy is available) or
based on both HRCT and lung biopsy (with application of the different criteria in
either situation).
If an evaluable HRCT <12 months prior to Screening is not
available, an HRCT can be performed at first Screening Visit to determine eligibility,
according to the same requirements as the historical HRCT. If a participant has an
indeterminate usual interstitial pneumonia (UIP) pattern and their HRCT is >6 months
old, if in the opinion of the Investigator their disease has progressed, an additional
HRCT may be obtained and reviewed for eligibility.
- FVC ≥45% of predicted normal at Screening Visits.
- Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7 at Screening Visits.
- DLco ≥30% and ≤90% of predicted, corrected for hemoglobin at first Screening Visit.
Key
Exclusion Criteria:
- Abnormalities detected on electrocardiogram (ECG) of either rhythm or conduction that
in the opinion of the Investigator are clinical significant.
Participants with
implantable cardiovascular devices (for example, pacemaker) affecting the QT interval
time may be enrolled in the study based upon Investigator judgment following
cardiologist consultation if deemed necessary, and only after discussion with the
Medical Monitor.
- Emphysema present on ≥50% of the HRCT, or the extent of emphysema is greater than the
extent of fibrosis, according to central review of the HRCT.
- Interstitial lung disease associated with known primary diseases (for example,
connective tissue disease, sarcoidosis and amyloidosis), exposures (for example,
radiation, silica, asbestos, and coal dust), or drugs (for example, amiodarone).
- Participants who cannot meet protocol-specified baseline stability criteria.
- Acute IPF exacerbation within 3 months prior to screening.
- Receiving nintedanib in combination with pirfenidone.
- Receiving systemic corticosteroids equivalent to prednisone >10 milligrams (mg)/day or
equivalent within 2 weeks prior to Screening.
- Use of any of the following therapies within 4 weeks prior to Screening and during the
Screening Period, or planned during the study: imatinib, ambrisentan, azathioprine,
mycophenolate mofetil, cyclophosphamide, cyclosporine A, tacrolimus, bosentan,
methotrexate, inhaled treprostinil, phosphodiesterase-5 inhibitors, including
sildenafil (unless for occasional use), prednisone at steady dose >10 mg/day or
equivalent, or other investigational therapy.
- History of cigarette smoking or vaping within the previous 3 months.
- Female participant who is pregnant or breastfeeding.
- Previous exposure to study intervention or known allergy/sensitivity to study drug.
- Receiving an investigational treatment within 28 days of randomization.
- Inadequate IV access.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Syndax Pharmaceuticals
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry, Other
Overall Status
Recruiting
Countries
Australia
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Arms & Interventions
Arms
Experimental: Axatilimab
Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period.
Placebo Comparator: Placebo
Participants will receive placebo every 2 weeks during the 26-week Treatment Period.
Interventions
Drug: - Axatilimab
Administered as intravenous (IV) infusion
Other: - Placebo
Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Wallace Street Specialist Centre, Brisbane, Australia