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

A

AmMax Bio

Status and phase

Withdrawn
Phase 2

Conditions

IPF

Treatments

Biological: AMB-05X
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05349760
AMB-053-01

Details and patient eligibility

About

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.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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 -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

AMB-05X
Experimental group
Description:
AMB-05X will be administered every 4 weeks for 24 weeks (for 6 treatments in total).
Treatment:
Biological: AMB-05X
Placebo
Placebo Comparator group
Description:
Placebo will be administered every 4 weeks for 24 weeks (for 6 treatments in total).
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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