A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis

AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.

Study Overview

• Status: Withdrawn
• Conditions: IPF
• Intervention / Treatment: Biological: AMB-05X; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects ≥40 years old.
2. History of confirmed diagnosis of IPF
3. Chest HRCT at Screening

4. Subjects who are either:

   • Not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) or
   • Being treated with approved IPF therapies (i.e., nintedanib or pirfenidone)
5. Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted
6. Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70
7. Has adequate hematologic, hepatic, and renal function

Exclusion Criteria:

1. Prior investigational drug use within 30 days or 5 half-lives
2. Presence of emphysema exceeding the extent of fibrosis
3. Active or anticipated need for lung transplant
4. Treatment with prednisone
5. Active cancer
6. Active or chronic infection with HCV, HBV, or HIV
7. Known active tuberculosis
8. History of or current immunosuppressive condition
9. IPF exacerbation within 12 weeks
10. Lower respiratory-tract infection requiring antibiotic therapy
11. Smoking
12. Other forms of interstitial lung disease
13. History of lung volume reduction surgery or lung transplant
14. Contraindications for forced expiratory maneuvers during spirometry
15. Unstable cardiac or pulmonary disease (other than IPF)
16. Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
17. History of drug or alcohol abuse -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMB-05X; AMB-05X will be administered every 4 weeks for 24 weeks (for 6 treatments in total).	Biological: AMB-05X; A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
Placebo Comparator: Placebo; Placebo will be administered every 4 weeks for 24 weeks (for 6 treatments in total).	Drug: Placebo; Saline/D5W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse events	Frequency and severity of reported treatment-emergent adverse events will be graded per CTCAE 5-point scale	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Function	Change in forced vital (FVC) capacity in liters	Week 28
Pharmacodynamics via CSF1	Plasma CSF1 assessment and other exploratory biomarkers	Week 28
ST GEORGE'S RESPIRATORY QUESTIONNAIRE IDIOPATHIC PULMONARY FIBROSIS (SGRQ-I)	Change in health-related quality of life, as measured by St. George's Respiratory Questionnaire (SGRQ-I)	Week 28
Cmax	Peak Plasma Concentration (Cmax) measurement	Week 24
AUC	Area under the plasma concentration versus time curve (AUC) measurement	Week 24

Collaborators and Investigators

• Sponsor: AmMax Bio, Inc.
• Investigators: Study Director: Dorothy Nguyen, MD, AmMax Bio, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Idiopathic Pulmonary Fibrosis; IPF
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: AMB-053-01

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