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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05349760

Enrollment

Registered

2022-04-27

Start date

2023-03-31

Completion date

2025-06-30

Last updated

2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IPF

Keywords

Idiopathic Pulmonary Fibrosis, IPF

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.

Interventions

BIOLOGICALAMB-05X

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

DRUGPlacebo

Saline/D5W

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

IRT and unblinded pharmacists

Intervention model description

2:1 randomization of active to placebo

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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 -

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026