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

Primary Purpose

IPF

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

AMB-05X

Placebo

About this trial

This is an interventional treatment trial for IPF focused on measuring Idiopathic Pulmonary Fibrosis, IPF

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)
Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
History of drug or alcohol abuse -

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AMB-05X

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Treatment-emergent adverse events

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

Secondary Outcome Measures

Pulmonary Function

Change in forced vital (FVC) capacity in liters

Pharmacodynamics via CSF1

Plasma CSF1 assessment and other exploratory biomarkers

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)

Cmax

Peak Plasma Concentration (Cmax) measurement

AUC

Area under the plasma concentration versus time curve (AUC) measurement

Full Information

NCT ID

NCT05349760

First Posted

March 31, 2022

Last Updated

January 17, 2023

Sponsor

AmMax Bio, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05349760

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Withdrawn

Why Stopped

to focus resources on other studies

Study Start Date

March 2023 (Anticipated)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AmMax Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IPF

Keywords

Idiopathic Pulmonary Fibrosis, IPF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

2:1 randomization of active to placebo

Masking

ParticipantInvestigator

Masking Description

IRT and unblinded pharmacists

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMB-05X

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

AMB-05X

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Saline/D5W

Primary Outcome Measure Information:

Title

Treatment-emergent adverse events

Description

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

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Pulmonary Function

Description

Change in forced vital (FVC) capacity in liters

Time Frame

Week 28

Title

Pharmacodynamics via CSF1

Description

Plasma CSF1 assessment and other exploratory biomarkers

Time Frame

Week 28

Title

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

Description

Change in health-related quality of life, as measured by St. George's Respiratory Questionnaire (SGRQ-I)

Time Frame

Week 28

Title

Cmax

Description

Peak Plasma Concentration (Cmax) measurement

Time Frame

Week 24

Title

AUC

Description

Area under the plasma concentration versus time curve (AUC) measurement

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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) Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women) History of drug or alcohol abuse -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dorothy Nguyen, MD

Organizational Affiliation

AmMax Bio, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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