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
NCT number | NCT05349760 |
Other study ID # | AMB-053-01 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2023 |
Est. completion date | June 2025 |
Verified date | January 2023 |
Source | AmMax Bio, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AmMax Bio, Inc. |
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 |
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