Clinical trial • Phase II • Respiratory
PIRFENIDONE for Progressive pulmonary fibrosis | Idiopathic pulmonary fibrosis
Phase II trial of PIRFENIDONE for Progressive pulmonary fibrosis | Idiopathic pulmonary fibrosis. open-label. 220 participants.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Progressive pulmonary fibrosis | Idiopathic pulmonary fibrosis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-02-2025
- First CTIS Authorization Date
- 03-06-2025
Trial design
open-label Phase II trial in Italy, Poland, Czechia and others.
- Open Label
- Yes
- Target Sample Size
- 220
- Trial Duration For Participant
- 364
Eligibility
Recruits 220 No vulnerable population selected. Written informed consent per the Institutional Review Board/Ethics Committee (IRB/EC) is required. Participants must be at least 18 years of age. No assent procedures for minors are described..
- Pregnancy Exclusion
- Is pregnant, nursing, or who plans to become pregnant while in the study.
- Vulnerable Population
- No vulnerable population selected. Written informed consent per the Institutional Review Board/Ethics Committee (IRB/EC) is required. Participants must be at least 18 years of age. No assent procedures for minors are described.
Inclusion criteria
- {"criterion_text":"- Provide written informed consent per the Institutional Review Board/Ethics Committee (IRB/EC)\n- Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either IPF or PPF and with the approval of the Investigator. IPF is defined as: A specific form of chronic fibrosing interstitial pneumonia limited to the lung and associated with the pathological pattern of usual interstitial pneumonia (American Thoracic Society 2000; Raghu et al, 2018). PPF is defined as: At least 2 of 3 criteria (worsening symptoms, radiological progression, and physiological progression) occurring within the past year with no alternative explanation in a patient with an interstitial lung disease other than IPF (Raghu et al, 2022). Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).\n- Male subjects and female subjects of childbearing potential (FOCBP) (defined as females who are fertile, following menarche and until becoming post-menopausal unless permanently sterile) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period. Male subjects must use a condom and female partners of male subjects who are of childbearing potential must use a highly effective method of contraception, defined below: a. A highly effective method of contraception is one that results in a low failure rate (i.e., <1% per year) when used consistently and correctly. The acceptable methods of contraception include: i. sexual abstinence, defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. ii. a vasectomized partner iii. bilateral tubal occlusion iv. any effective intrauterine device/hormone-releasing system, and progesterone-only (oral, injectable, or implantable) or combined (estrogen- and progesterone-containing; oral, intravaginal, or transdermal) hormonal contraception associated with inhibition of ovulation. Note: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. b. The efficacy of oral hormonal contraceptives may be compromised by vomiting and/or diarrhea or other conditions where the drug absorption may be reduced. Advise women taking oral hormonal contraceptives experiencing these conditions to use alternative highly effective contraception. Note: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. In the absence of 12 months of amenorrhea, a single folliclestimulating hormone measurement is insufficient to document menopause.\n- Willingness to comply with all study visits and requirements.\n- Male or female at least 18 years of age at Screening/Baseline (Day 1)."}
Exclusion criteria
- {"criterion_text":"- Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.\n- Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit).\n- Subjects who experienced an acute exacerbation of IPF or of PPF (as defined in Section 12.2.3) within 3 months of Day 1 (Screening/Baseline Visit).\n- Any conditions or abnormalities (including electrocardiogram [ECG] or laboratory abnormalities) which, in the opinion of the Investigator may compromise the safety of the subject or interfere with the subject participating in or completing the study.\n- History of non-adherence to medical regimens, unreliability, medical condition, mental instability or cognitive impairment that, in the opinion of the Investigator, could compromise the validity of informed consent, compromise the safety of the subject, or lead to non-adherence with the study protocol or inability to conduct the study procedures.\n- Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is longer. Subjects may be enrolled in registries.\n- History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.\n- Is pregnant, nursing, or who plans to become pregnant while in the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of adverse events of special interest (AESIs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of treatment-emergent all-cause deaths","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of treatment-emergent respiratory deaths","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of exacerbation of pulmonary fibrosis","definition_or_measurement_approach":""}
- {"endpoint_text":"- Changes from baseline in clinical laboratory tests and vital signs","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in forced vital capacity (FVC) (mL) at intervals of 6 months","definition_or_measurement_approach":"Change from baseline in forced vital capacity (FVC) measured in mL at intervals of 6 months"}
- {"endpoint_text":"- Annual rate of decline in FVC (mL)","definition_or_measurement_approach":"Annual rate of decline in forced vital capacity (FVC) measured in mL"}
Recruitment
- Planned Sample Size
- 220
- Recruitment Window Months
- 80
- Consent Approach
- Written informed consent per Institutional Review Board/Ethics Committee (IRB/EC) is required. Participants must be at least 18 years old and provide their own consent. Informed consent documents (SIS and ICF) are available in multiple languages (English, Italian, French, Spanish, German, Dutch, Polish, Czech) as indicated in the submission documents. No assent procedures for minors are described.
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 121
Italy
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 178
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Internal Medicine – Pulmonology 1
- Principal Investigator Name
- Francesco Amati
- Principal Investigator Email
- francesco.amati@hunimed.eu
- Contact Person Name
- Francesco Amati
- Contact Person Email
- francesco.amati@hunimed.eu
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Pneumology Division
- Principal Investigator Name
- Angelo Guido Corsico
- Principal Investigator Email
- corsico@unipv.it
- Contact Person Name
- Angelo Guido Corsico
- Contact Person Email
- corsico@unipv.it
- Site Name
- Multimedica S.p.A.
- Department Name
- Division of Pulmonary disease, Intensive Respiratory Care U
- Principal Investigator Name
- Sergio Harari
- Principal Investigator Email
- sergio@sergioharari.it
- Contact Person Name
- Sergio Harari
- Contact Person Email
- sergio@sergioharari.it
Poland
- Earliest CTIS Part Ii Submission Date
- 02-05-2025
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 273
- Number Of Sites
- 4
- Number Of Participants
- 30
Sites
- Site Name
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- Oddział Pneumologii
- Principal Investigator Name
- Adam Barczyk
- Principal Investigator Email
- abarczyk@icloud.com
- Contact Person Name
- Adam Barczyk
- Contact Person Email
- abarczyk@icloud.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Alergologii
- Principal Investigator Name
- Amelia Szymanowska-Narloch
- Principal Investigator Email
- aszymanowska@gumed.edu.pl
- Contact Person Name
- Amelia Szymanowska-Narloch
- Contact Person Email
- aszymanowska@gumed.edu.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
- Department Name
- Oddział Kliniczny Pulmonologii i Alergologii z Pododdziałem Chrób Wewnętrznych
- Principal Investigator Name
- Wojciech Piotrowski
- Principal Investigator Email
- wojciech.piotrowski@umed.lodz.pl
- Contact Person Name
- Wojciech Piotrowski
- Contact Person Email
- wojciech.piotrowski@umed.lodz.pl
- Site Name
- Vitamed Galaj I Cichomski Sp. j.
- Department Name
- Poradnia Pulmonologiczna
- Principal Investigator Name
- Iwona Patyk
- Principal Investigator Email
- i.patyk@vitamed.info
- Contact Person Name
- Iwona Patyk
- Contact Person Email
- i.patyk@vitamed.info
Czechia
- Earliest CTIS Part Ii Submission Date
- 02-05-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 266
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Pneumologicka klinika
- Principal Investigator Name
- Martina Sterclova
- Principal Investigator Email
- martina.sterclova@ftn.cz
- Contact Person Name
- Martina Sterclova
- Contact Person Email
- martina.sterclova@ftn.cz
Netherlands
- Earliest CTIS Part Ii Submission Date
- 02-05-2025
- Latest Decision Or Authorization Date
- 22-01-2026
- Processing Time Days
- 265
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- St. Antonius Ziekenhuis
- Department Name
- Department of Pulmonology
- Principal Investigator Name
- Marcel Veltkamp
- Principal Investigator Email
- m.veltkamp@antoniusziekenhuis.nl
- Contact Person Name
- Marcel Veltkamp
- Contact Person Email
- m.veltkamp@antoniusziekenhuis.nl
France
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 137
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de Pneumologie
- Principal Investigator Name
- Vincent Cottin
- Principal Investigator Email
- vincent.cottin@chu-lyon.fr
- Contact Person Name
- Vincent Cottin
- Contact Person Email
- vincent.cottin@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Département de Pneumologie
- Principal Investigator Name
- Frederic Gagnadoux
- Principal Investigator Email
- fgagnadoux@chu-angers.fr
- Contact Person Name
- Frederic Gagnadoux
- Contact Person Email
- fgagnadoux@chu-angers.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Service de Pneumologie et Explorations Fonctionnelles Respiratoires
- Principal Investigator Name
- Laurent Plantier
- Principal Investigator Email
- laurent.plantier@univ-tours.fr
- Contact Person Name
- Laurent Plantier
- Contact Person Email
- laurent.plantier@univ-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service de Pneumologie et Maladies Respiratoires
- Principal Investigator Name
- Arnaud Bourdin
- Principal Investigator Email
- a-bourdin@chu-montpellier.fr
- Contact Person Name
- Arnaud Bourdin
- Contact Person Email
- a-bourdin@chu-montpellier.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 18-08-2025
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 163
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Neumology
- Principal Investigator Name
- Luis Puente Maestu
- Principal Investigator Email
- luis.puente@salud.madrid.org
- Contact Person Name
- Luis Puente Maestu
- Contact Person Email
- luis.puente@salud.madrid.org
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Neumology
- Principal Investigator Name
- Ana Dolores Romero Ortiz
- Principal Investigator Email
- anadoloresromeroortiz@gmail.com
- Contact Person Name
- Ana Dolores Romero Ortiz
- Contact Person Email
- anadoloresromeroortiz@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Neumology
- Principal Investigator Name
- José Luis Velasco Garrido
- Principal Investigator Email
- josel.velasco.sspa@juntadeandalucia.es
- Contact Person Name
- José Luis Velasco Garrido
- Contact Person Email
- josel.velasco.sspa@juntadeandalucia.es
Germany
- Earliest CTIS Part Ii Submission Date
- 28-08-2025
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 151
- Number Of Sites
- 3
- Number Of Participants
- 34
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Interstitial and Rare Lung Disease Centre
- Principal Investigator Name
- Francesco Tommaso Bonella
- Principal Investigator Email
- francesco.bonella@rlk.uk-essen.de
- Contact Person Name
- Francesco Tommaso Bonella
- Contact Person Email
- francesco.bonella@rlk.uk-essen.de
- Site Name
- Studienzentrum Dr. Claus Keller
- Department Name
- Studienzentrum Dr. Klaus Keller
- Principal Investigator Name
- Klaus Keller
- Principal Investigator Email
- ckeller-studien@praxis-ckeller.de
- Contact Person Name
- Klaus Keller
- Contact Person Email
- ckeller-studien@praxis-ckeller.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Pneumologie und Infektiologie, Klinisches Studienzentrum
- Principal Investigator Name
- Jonas Schupp
- Principal Investigator Email
- Schupp.jonas@mh-hannover.de
- Contact Person Name
- Jonas Schupp
- Contact Person Email
- Schupp.jonas@mh-hannover.de
Sponsor
Primary sponsor
- Full Name
- Avalyn Pharma Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Pirfenidone Solution for Inhalation
- Active Substance
- PIRFENIDONE
- Modality
- Small molecule
- Routes Of Administration
- INHALATION
- Route
- INHALATION
- Maximum Dose
- 200 mg
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