Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06132256
• Other study ID #: SNDX-6352-0506
• Secondary ID: 2022-502954-15-0
• Status: Recruiting
• Phase: Phase 2
• Start date: December 11, 2023
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Syndax Pharmaceuticals
• Contact: Syndax Pharmaceuticals
• Phone: 781-419-1400
• Email: clinicaltrials[@]syndax.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the efficacy and safety of axatilimab in participants with IPF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: June 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Axatilimab
Administered as intravenous (IV) infusion

Other:
• Placebo
Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient.

Locations

Country	Name	City	State
Australia	Wallace Street Specialist Centre	Brisbane
Australia	Institute for Respiratory Health	Nedlands
Australia	Mater Misericordiae Ltd	Newstead	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Syndax Pharmaceuticals	DevPro Biopharma

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])		Baseline through Week 26
Secondary	Time to disease progression	Disease progression is defined as absolute FVC percent predicted decline of =10%, or occurrence of lung transplant or all-cause death prior to Week 26.	Baseline through Week 26
Secondary	Annualized rate of decline in FVC percent predicted over 26 weeks		Baseline through Week 26
Secondary	Change in St. George's Respiratory Questionnaire (SGRQ) score from Baseline to Week 26		Baseline, Week 26
Secondary	Change in diffusion capacity for carbon monoxide (DLco % of predicted, corrected for hemoglobin) from Baseline to Week 26		Baseline, Week 26