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

Phase 2

Withdrawn

• Conditions: IPF
• Interventions: Biological: AMB-05X; Drug: Placebo

• Registration Number: NCT05349760
• Lead Sponsor: AmMax Bio, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19
• Study Start: 2023-03
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pulmonary Function	Week 28	Change in forced vital (FVC) capacity in liters
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)
Pharmacodynamics via CSF1	Week 28	Plasma CSF1 assessment and other exploratory biomarkers
Cmax	Week 24	Peak Plasma Concentration (Cmax) measurement
AUC	Week 24	Area under the plasma concentration versus time curve (AUC) measurement