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

NCT05349760 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: AMB-053-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

IPF

Keywords

Idiopathic Pulmonary Fibrosis; IPF

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent adverse events

  Frequency and severity of reported treatment-emergent adverse events will be graded per CTCAE 5-point scale

  Week 24

Secondary Outcomes (5)

• Pulmonary Function

  Week 28

• Pharmacodynamics via CSF1

  Week 28

• ST GEORGE'S RESPIRATORY QUESTIONNAIRE IDIOPATHIC PULMONARY FIBROSIS (SGRQ-I)

  Week 28

• Cmax

  Week 24

• AUC

  Week 24

Study Arms (2)

AMB-05X

EXPERIMENTAL

AMB-05X will be administered every 4 weeks for 24 weeks (for 6 treatments in total).

Biological: AMB-05X

Placebo

PLACEBO COMPARATOR

Placebo will be administered every 4 weeks for 24 weeks (for 6 treatments in total).

Drug: Placebo

Interventions

AMB-05X BIOLOGICAL

A fully human monoclonal immunoglobulin (IgG2) directed against c-fms

AMB-05X

Placebo DRUG

Saline/D5W

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥40 years old.
• History of confirmed diagnosis of IPF
• Chest HRCT at Screening
• 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)
• Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted
• Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70
• Has adequate hematologic, hepatic, and renal function

You may not qualify if:

• Prior investigational drug use within 30 days or 5 half-lives
• Presence of emphysema exceeding the extent of fibrosis
• Active or anticipated need for lung transplant
• Treatment with prednisone
• Active cancer
• Active or chronic infection with HCV, HBV, or HIV
• Known active tuberculosis
• History of or current immunosuppressive condition
• IPF exacerbation within 12 weeks
• Lower respiratory-tract infection requiring antibiotic therapy
• Smoking
• Other forms of interstitial lung disease
• History of lung volume reduction surgery or lung transplant
• Contraindications for forced expiratory maneuvers during spirometry
• Unstable cardiac or pulmonary disease (other than IPF)

Sponsors & Collaborators

• AmMax Bio, Inc.: lead

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dorothy Nguyen, MD

  AmMax Bio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: IRT and unblinded pharmacists
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 randomization of active to placebo

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 27, 2022
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share