Actively Recruiting
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Led by Avalyn Pharma Inc. · Updated on 2026-04-06
375
Participants Needed
152
Research Sites
164 weeks
Total Duration
On this page
Sponsors
A
Avalyn Pharma Inc.
Lead Sponsor
D
DevPro Biopharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
CONDITIONS
Official Title
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant meets criteria for progressive pulmonary fibrosis (PPF) with radiological evidence of pulmonary fibrosis
- Physiological evidence of disease progression within 24 months despite treatment
- Relative decline in forced vital capacity (FVC) ≥10% predicted or decline 5-<10% with worsening symptoms or radiological progression
- Worsening respiratory symptoms and radiological evidence of disease progression
- FVC ≥45% predicted at screening
- FEV1/FVC ≥0.7 or age-adjusted lower limit of normal at screening
- Diffusing capacity of lung for carbon monoxide (DLCO) ≥30% predicted at screening
- Able to perform acceptable spirometry per ATS/ERS criteria
- If on nintedanib, must be on stable dose for at least 6 months or off nintedanib for at least 12 weeks
You will not qualify if you...
- Current or recent (within 3 months) treatment with oral pirfenidone
- Elevated liver enzymes (ALT or AST ≥3 times upper limit of normal) or bilirubin >2.0 x upper limit of normal
- Severe renal disease with creatinine clearance <30 mL/min
- Diagnosis of idiopathic pulmonary fibrosis (IPF)
- Greater emphysema than fibrotic interstitial lung disease on HRCT
- Significant clinical worsening of progressive pulmonary fibrosis between screening visits
- Unable to meet baseline lung function stability criteria for forced vital capacity (FVC)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 152 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States, 85259
Actively Recruiting
3
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
4
Cedars-Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
5
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
6
Newport Native MD, Inc.
Newport Beach, California, United States, 92663
Actively Recruiting
7
Paradigm Clinical Research - Redding
Redding, California, United States, 96001
Actively Recruiting
8
University of California - San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
9
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
10
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
11
UCONN Health
Farmington, Connecticut, United States, 06030
Actively Recruiting
12
Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
13
Clinical Site Partners, LCC
Leesburg, Florida, United States, 34748
Actively Recruiting
14
Renstar Medical Research
Ocala, Florida, United States, 34470
Actively Recruiting
15
Clinical Site Partners
Winter Park, Florida, United States, 32789
Actively Recruiting
16
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States, 30309
Actively Recruiting
17
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
18
Endeavor Health
Evanston, Illinois, United States, 60201
Actively Recruiting
19
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
20
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
21
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
22
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Actively Recruiting
23
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
24
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
25
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
26
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
27
Hannibal Regional Healthcare System
Hannibal, Missouri, United States, 63401
Actively Recruiting
28
Northwell Health - Mount Kisco
Mount Kisco, New York, United States, 10549
Actively Recruiting
29
NYU Langone Health
New York, New York, United States, 10017
Actively Recruiting
30
Weill Cornell
New York, New York, United States, 10021
Actively Recruiting
31
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
32
Columbia University
New York, New York, United States, 10032
Actively Recruiting
33
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
34
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
35
Piedmont HealthCare, PA
Statesville, North Carolina, United States, 28625
Actively Recruiting
36
Accellacare
Wilmington, North Carolina, United States, 28401
Actively Recruiting
37
Southeastern Research Center
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
38
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
39
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
40
Summit Health
Bend, Oregon, United States, 97701
Actively Recruiting
41
The Oregon Clinic Pulmonary East
Portland, Oregon, United States, 97220
Actively Recruiting
42
The Oregon Clinic Pulmonary West
Portland, Oregon, United States, 97225
Actively Recruiting
43
The Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
44
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
45
Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
46
Lowcountry Lung and Critical Care
Charleston, South Carolina, United States, 29406
Actively Recruiting
47
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
48
Clinical Trials Center of Middle Tennessee
Franklin, Tennessee, United States, 37067
Actively Recruiting
49
Vanderbilt Lung Institute
Nashville, Tennessee, United States, 37204
Actively Recruiting
50
Baylor Scott & White Research Institute, Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
51
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
52
El Paso Pulmonary Association
El Paso, Texas, United States, 79902
Actively Recruiting
53
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
54
The University of Texas Health Science Center
Houston, Texas, United States, 77030
Actively Recruiting
55
Metroplex Pulmonary and Sleep Center, PA
McKinney, Texas, United States, 75069
Actively Recruiting
56
Intermountain Medical Center
Murray, Utah, United States, 84157
Actively Recruiting
57
University of Utah Health
Salt Lake City, Utah, United States, 84108
Actively Recruiting
58
Inova Healthcare
Falls Church, Virginia, United States, 22042
Actively Recruiting
59
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
60
Fundacion Respirar
Buenos Aires, Buenos Aires, Argentina, 1427
Actively Recruiting
61
CINME
Buenos Aires, Buenos Aires, Argentina, C1056AB
Actively Recruiting
62
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABH
Actively Recruiting
63
Instituto Ave Pulmo, Fundacion Enfisema
Mar del Plata, Buenos Aires, Argentina, 7600
Actively Recruiting
64
Clinica Monte Grande
Monte Grande, Buenos Aires, Argentina, 1842
Actively Recruiting
65
Centro Respiratorio Quilmes
Quilmes, Buenos Aires, Argentina, B1878
Actively Recruiting
66
Instituto de Medicina Respiratoria
Córdoba, Córdoba Province, Argentina, 5003
Actively Recruiting
67
CIMER Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
68
Investigaciones En Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
69
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
70
Nepean Lung & Sleep
Kingswood, New South Wales, Australia, 2745
Actively Recruiting
71
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
Actively Recruiting
72
Macquarie University Clinical Trials Unit
Sydney, New South Wales, Australia, 2109
Actively Recruiting
73
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
74
Institute for Respiratory Health
Nedlands, Perth West Australia, Australia, 6009
Actively Recruiting
75
Wallace Street Specialist Centre/Lung Research QLD Pty Ltd
Brisbane, Queensland, Australia, 4032
Actively Recruiting
76
Lung Research Victoria
Footscray, Victoria, Australia, 3011
Actively Recruiting
77
Alfred Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
78
Canberra Hospital
Canberra, Australia, 2605
Actively Recruiting
79
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
80
CHU de Liège
Liège, Belgium, 4000
Actively Recruiting
81
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
Actively Recruiting
82
Dynamic Drug Advancement
Ajax, Ontario, Canada, L1S2J5
Actively Recruiting
83
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
84
Research Institute McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
85
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, Canada, G1V4G5
Actively Recruiting
86
CIC Mauricie
Trois-Rivières, Quebec, Canada, G8T7A1
Actively Recruiting
87
CHU de Rennes
Rennes, Cedex NA, France, 35033
Actively Recruiting
88
CHU Tours
Tours, Indre et Loire, France, 37000
Actively Recruiting
89
Robert Schuman Hospital UNEOS
Metz, Lorraine, France, 57000
Actively Recruiting
90
Louis Pradel Hospital
Lyon, Lyon, France, 69677
Actively Recruiting
91
University of Montpellier
Montpellier, Montpellier, France, 34295
Actively Recruiting
92
CHU Angers
Angers, France, 49933
Actively Recruiting
93
APHP - Hopital Bicetre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
94
Hôpital Paris St Jozeph
Paris, France, 75014
Actively Recruiting
95
Hôpital Haut-Lévêque
Pessac, France, 33604
Actively Recruiting
96
Pneumologisches Studienzentrum München-West
Munich, Bavaria, Germany, 81241
Actively Recruiting
97
Muenchen Klinik Bogenhausen - Klinik für Pneumologie und Pneumologische Onkologie
München, Bavaria, Germany, 81925
Actively Recruiting
98
RoMed Klinikum Rosenheim
Rosenheim, Bavaria, Germany, 83022
Actively Recruiting
99
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
100
Studienzentrum Dr. Claus Keller
Frankfurt, Main Hessia, Germany, 60389
Actively Recruiting
101
Ruhrlandklinik Essen, Klinik fuer Pneumologie
Essen, North Rhine-Westphalia, Germany, 45239
Actively Recruiting
102
Universitätsmedizin Mainz - Zentrum für Thoraxerkrankungen
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
103
Uniklinikum Leipzig Medizinische Klinik II - Bereich
Leipzig, Saxony, Germany, 04103
Actively Recruiting
104
Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie
Berlin, State of Berlin, Germany, 12351
Actively Recruiting
105
A.O.U. delle Marche - Ospedale di Torrette
Torrette, Ancona, Italy, 60126
Actively Recruiting
106
Azienda Ospedaliera dei Colli - Ospedale Monaldi
Naples, Campania, Italy, 80131
Actively Recruiting
107
Università degli Studi di Napoli Federico II - Ospedale Monaldi
Naples, Campania, Italy, 80131
Actively Recruiting
108
IRCCS AOU di Bologna - Policlinico Sant' Orsola
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
109
Azienda Sanitaria Universitaria Giuliano Isontina
Venezia, Giulia, Italy, 34149
Actively Recruiting
110
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
Pavia, Lombardy, Italy, 27100
Actively Recruiting
111
Ospedale San Giuseppe
Milan, Milano, Italy, 20123
Actively Recruiting
112
HUMANITAS Research Hospital
Rozzano, Milano, Italy, 20089
Actively Recruiting
113
A.O.U. Policlinico G. Rodolico
Catania, Sicily, Italy, 95123
Actively Recruiting
114
St Antoniusziekenhuis
Nieuwegein, Utrecht, Netherlands, 3435
Actively Recruiting
115
Erasmus University Medical Center
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
116
Greenlane Clinical Centre
Auckland, Auckland, New Zealand, 1051
Actively Recruiting
117
Health New Zealand
Christchurch, Canterbury, New Zealand, 8011
Actively Recruiting
118
Dunedin Hospital
Dunedin, Dunedine, New Zealand, 9016
Actively Recruiting
119
Bay of Plenty Clinical School
Tauranga, South Tauranga, New Zealand, 3112
Actively Recruiting
120
Vitamed Galaj I Cichomski sp.j.
Bydgoszcz, Bydgoszc, Poland, 85-079
Actively Recruiting
121
University Hospital in Krakow
Krakow, Krakow, Poland, 30-688
Actively Recruiting
122
Department of Pneumology of the University Hospital No 1
Lodz, Poland, 90-153
Actively Recruiting
123
PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek Suzin
Lodz, Poland, 90-602
Actively Recruiting
124
AppleTreeClinics Network
Lodz, Łódź Voivodeship, Poland, 90-349
Actively Recruiting
125
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain, 18014
Actively Recruiting
126
Hospital de Sant Pau y la Santa Creu
Barcelona, Barcelona, Spain, 08025
Actively Recruiting
127
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
128
Hospital Gregorio Marañon
Madrid, Madrid, Spain, 28007
Actively Recruiting
129
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
130
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain, 29010
Actively Recruiting
131
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
132
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain, 41013
Actively Recruiting
133
Hospital Universitary de Bellvitge
Barcelona, Spain, 08908
Actively Recruiting
134
Hospital Universitario Puerta del Mar - Leon-Jimenez
Cadiz, Spain, 11009
Actively Recruiting
135
Ege University Medical Faculty Hospital
Bornova, İzmir, Turkey (Türkiye), 35100
Actively Recruiting
136
Cukurova University Medical Faculty
Adana, Turkey (Türkiye), 01240
Actively Recruiting
137
Health Sciences University, Gulhane Faculty of Medicine
Ankara, Turkey (Türkiye), 06010
Actively Recruiting
138
Hull University Teaching Hospital NHS Trust
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Actively Recruiting
139
Birmingham Heartlands Hospital
Birmingham, Heartlands, United Kingdom, B95SS
Actively Recruiting
140
Leicester Biomedical Research Centre - Respiratory Theme
Glenfield, Leicester, United Kingdom, LE3 9QP
Actively Recruiting
141
St George's University Hospitals NHS Foundation Trust
London, London, United Kingdom, sw17 0QT
Actively Recruiting
142
ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
Birmingham, Midlands, United Kingdom, B15 2GW
Actively Recruiting
143
C-TRIC Altnagelvin Hospital
Londonderry, Northern Ireland, United Kingdom, BT46
Actively Recruiting
144
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxon, United Kingdom, OX3 7LE
Actively Recruiting
145
Royal Devon
Exeter, South West, United Kingdom, EX2 5DW
Actively Recruiting
146
The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Actively Recruiting
147
St James University Hospital - LTHT
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Actively Recruiting
148
Royal Papworth Hospital
Cambridge, United Kingdom, CB2 0BB
Actively Recruiting
149
Royal Brompton Hospital
London, United Kingdom, SW3 6HP
Actively Recruiting
150
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M23 9LT
Actively Recruiting
151
Nottingham University NHS Trust
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
152
University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom, ST4 6QG
Actively Recruiting
Research Team
C
Craig S. Conoscenti, MD
CONTACT
D
Daniele Tompkins
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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