Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)

Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial) - Efficacy and Safety of Nintedanib in Idiopathic Pleuroparenchymal Fibroelastosis (Phase 2 trial)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042946

Enrollment

Registered

2021-02-01

Start date

2021-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pleuroparenchymal fibroelastosis

Interventions

150 mg bid nintedanib over 26 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Provided written informed consent Confirmed definite idiopathic PPFE or probable idiopathic PPFE before the registration Have more than 50% of %FVC Have more than relative 5% decline of %FVC within 1 year of visit 1 etc.

Exclusion criteria

Exclusion criteria: Have a history of treatment either with pirfenidone or nintedanib NAC, prednisone > 15 mg/day or equivalent, azathioprine, cyclosporine or cyclophosphamide received within 8 weeks of visit 1 Have airway obstruction Have lung cancer Have pulmonary hypertension Developed acute exacerbation within 3 months of visit 1 etc.

Design outcomes

Primary

Measure	Time frame
%FVC decline rate during 26-week treatment of nintedanib versus the rate of baseline	—

Countries

Japan

Contacts

Public ContactKojin Murakami

Graduate School of Biomedical Sciences Tokushima University Department of Respiratory Medicine and Rheumatology

murakami.kojin@tokushima-u.ac.jp088-633-7127

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026