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

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)

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

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Axatilimab; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Syndax Pharmaceuticals; Phone Number: 781-419-1400; Email: clinicaltrials@syndax.com

Study Locations

• Australia
  • Brisbane, Australia, 4032
    • Recruiting
    • Wallace Street Specialist Centre
  • Nedlands, Australia, 6009
    • Recruiting
    • Institute for Respiratory Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Axatilimab; Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period.	Drug: Axatilimab; Administered as intravenous (IV) infusion; Other Names: SNDX-6352
Placebo Comparator: Placebo; Participants will receive placebo every 2 weeks during the 26-week Treatment Period.	Other: Placebo; Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])	Baseline through Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Annualized rate of decline in FVC percent predicted over 26 weeks		Baseline through Week 26
Change in St. George's Respiratory Questionnaire (SGRQ) score from Baseline to Week 26		Baseline, Week 26
Change in diffusion capacity for carbon monoxide (DLco % of predicted, corrected for hemoglobin) from Baseline to Week 26		Baseline, Week 26

Collaborators and Investigators

• Sponsor: Syndax Pharmaceuticals
• Collaborators: DevPro Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: SNDX-6352-0506; 2022-502954-15-00 (Other Identifier: EU-CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes