Status:
WITHDRAWN
A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
AmMax Bio, Inc.
Conditions:
IPF
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05349760
Start Date
March 1 2023
End Date
June 1 2025
Last Update
January 19 2023
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