A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
NCT ID: NCT05349760
Last Updated: 2023-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-03-31
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AMB-05X
AMB-05X will be administered every 4 weeks for 24 weeks (for 6 treatments in total).
AMB-05X
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
Placebo
Placebo will be administered every 4 weeks for 24 weeks (for 6 treatments in total).
Placebo
Saline/D5W
Interventions
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AMB-05X
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
Placebo
Saline/D5W
Eligibility Criteria
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Inclusion Criteria
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
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 -
40 Years
ALL
No
Sponsors
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AmMax Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dorothy Nguyen, MD
Role: STUDY_DIRECTOR
AmMax Bio, Inc.
Other Identifiers
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AMB-053-01
Identifier Type: -
Identifier Source: org_study_id
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