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

IPF Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05349760
• Other study ID #: AMB-053-01
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2023
• Est. completion date: June 2025

Study information

• Verified date: January 2023
• Source: AmMax Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• IPF
• Pulmonary Fibrosis

Intervention

Biological:
• AMB-05X
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms

Drug:
• Placebo
Saline/D5W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AmMax Bio, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse events	Frequency and severity of reported treatment-emergent adverse events will be graded per CTCAE 5-point scale	Week 24
Secondary	Pulmonary Function	Change in forced vital (FVC) capacity in liters	Week 28
Secondary	Pharmacodynamics via CSF1	Plasma CSF1 assessment and other exploratory biomarkers	Week 28
Secondary	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
Secondary	Cmax	Peak Plasma Concentration (Cmax) measurement	Week 24
Secondary	AUC	Area under the plasma concentration versus time curve (AUC) measurement	Week 24