Science and Research

IMPAHCT: A randomized phase 2b/3 study of inhaled imatinib for pulmonary arterial hypertension

AV-101 (imatinib) powder for inhalation, an investigational dry powder inhaled formulation of imatinib designed to target the underlying pathobiology of pulmonary arterial hypertension, was generally well tolerated in healthy adults in a phase 1 single and multiple ascending dose study. Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT; NCT05036135) is a phase 2b/3, randomized, double-blind, placebo-controlled, dose-ranging, and confirmatory study. IMPAHCT is designed to identify an optimal AV-101 dose (phase 2b primary endpoint: pulmonary vascular resistance) and assess the efficacy (phase 3 primary endpoint: 6-min walk distance), safety, and tolerability of AV-101 dose levels in subjects with pulmonary arterial hypertension using background therapies. The study has an operationally seamless, adaptive design allowing for continuous recruitment. It includes three parts; subjects enrolled in Part 1 (phase 2b dose-response portion) or Part 2 (phase 3 intermediate portion) will be randomized 1:1:1:1 to 10, 35, 70 mg AV-101, or placebo (twice daily), respectively. Subjects enrolled in Part 3 (phase 3 optimal dose portion) will be randomized 1:1 to the optimal dose of AV-101 and placebo (twice daily), respectively. All study parts include a screening period, a 24-week treatment period, and a 30-day safety follow-up period; the total duration is

  • Gillies, H.
  • Chakinala, M. M.
  • Dake, B. T.
  • Feldman, J. P.
  • Hoeper, M. M.
  • Humbert, M.
  • Jing, Z. C.
  • Langley, J.
  • McLaughlin, V. V.
  • Niven, R. W.
  • Rosenkranz, S.
  • Zhang, X.
  • Hill, N. S.

Keywords

  • dry powder inhaler
  • effectiveness
  • study design
  • tolerability
  • tyrosine kinase inhibitor
Publication details
DOI: 10.1002/pul2.12352
Journal: Pulm Circ
Pages: e12352 
Number: 1
Work Type: Original
Location: BREATH
Disease Area: PH
Partner / Member: MHH
Access-Number: 38532768

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