Idiopathic Pulmonary FibrosisPhase 2NCT07284459
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing PIPE-791 Dose A and PIPE-791 Dose B in people with Idiopathic Pulmonary Fibrosis, run by Contineum Therapeutics at 99 sites in 16 countries.
Trial summary
This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- PIPE-791 Dose A and PIPE-791 Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 99 sitesin 16 countries
- Study dates
- 8 Jan 2026to Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 40 years of age at the time of Randomization.
- A diagnosis of IPF within 7 years prior to Screening, based on the 2022 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP.
- Percent predicted (pp) FVC ≥ 40% on Screening spirometry.
- Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently.
Who cannot join
- Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.
- Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.
- Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.
- Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.
- Female participants must not be of childbearing potential.
- Additional inclusion and exclusion criteria apply.
Trial locations and contacts
99 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
99 sites in 16 countries
Argentina15 sites, 15 recruiting
- Recruiting
CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215
Buenos Aires, Buenos Aires F.D., C1056ABI
- Recruiting
STAT Research S.A.
Buenos Aires, C1023AAB
- Recruiting
Consultorios Médicos Organización del Buen Ayre SRL
Buenos Aires, C1425FVH
- Recruiting
Centro Médico Dra de Salvo - Fundacion Respirar - PPDS
Buenos Aires, C1426ABP
- Recruiting
Instituto de Medicina Respiratoria - IMER
Córdoba, X5003DCE
- Recruiting
Instituto Ave Pulmo
Mar del Plata, Buenos Aires, B7602DCK
- Recruiting
Centro Respiratorio Quilmes
Quilmes, Buenos Aires, B1878FNR
- Recruiting
Instituto de Especialidades de la Salud Rosario - Clínica del Tórax
Rosario, Santa Fe Province, S2000DBS
- Recruiting
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe Province, S2000DEJ
- Recruiting
Centro de Diagnóstico Y Rehabilitación - Santa Fe - San Luis
San Luis, Santa Fe Province, S3000GBL
- Recruiting
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, Tucumán Province, T4000AXL
- Recruiting
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Tucumán Province, T4000CBC
- Recruiting
IPR-Investigaciones en Patologías Respiratorias
San Miguel de Tucumán, Tucumán Province, T4000IAP
- Recruiting
Centro Modelo de Cardiología-Laprida 554
San Miguel de Tucumán, Tucumán Province, T4000IFL
- Recruiting
IbaMedica
Santa Fe, S3000ASF
Israel11 sites, 11 recruiting
- Recruiting
Assuta Ashdod University Medical Center
Ashdod, Southern District, 7747629
- Recruiting
The Barzilai University Medical Center
Ashkelon, Southern District, 7830604
- Recruiting
Shamir Medical Center
Be’er Ya‘aqov, Central District, 7033001
- Recruiting
Hillel Yaffe Medical Center
Hadera, Haifa District, 3820302
- Recruiting
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, Jerusalem, 9112001
- Recruiting
Shaare Zedek Medical Center
Jerusalem, Yerushala, 9103102
- Recruiting
Meir Medical Center
Kafr Saba, Central District, 4428164
- Recruiting
Rabin Medical Center - PPDS
Petah Tikva, Central District, 4941492
- Recruiting
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Central District, 5262100
- Recruiting
Kaplan Medical Center
Rehovot, Central District, 7661041
- Recruiting
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, 6423906
South Korea9 sites, 9 recruiting
- Recruiting
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong District, 03312
- Recruiting
Severance Hospital Yonsei University Health System
Seoul, Seodaemun, 03722
- Recruiting
Samsung Medical Center
Seoul, Seoul, 06351
- Recruiting
Soon Chun Hyang University Hospital
Seoul, Yongsan-gu, 04401
- Recruiting
Korea University Anam Hospital
Seoul, 2841
- Recruiting
Asan Medical Center
Songpa-dong, Seoul, 05505
Australia8 sites, 8 recruiting
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
- Recruiting
The Prince Charles Hospital
Chermside, Queensland, 4032
- Recruiting
Greenslopes Private Hospital
Greenslopes, Queensland, 4120
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
Institute for Respiratory Health
Midland, Western Australia, 6056
- Recruiting
TrialsWest Pty Ltd
Spearwood, Western Australia, 6163
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Canada7 sites, 7 recruiting
- Recruiting
Dynamic Drug Advancement Ltd.
Ajax, Ontario, L1S 2J5
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Québec, Quebec, G1V 4G5
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
- Recruiting
Centre d'investigation Clinique Mauricie
Trois-Rivières, Quebec City, G8T 7A1
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
- Recruiting
Dr. Anil Dhar Medicine Professional Corporation
Windsor, Ontario, N8X 5A6
United Kingdom7 sites, 7 recruiting
- Recruiting
Birmingham Heartlands Hospital
Birmingham, B3 3HX
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA
- Recruiting
NIHR Leicester Biomedical Research Centre - Glenfield Hospital
Leicester, England, LE3 9QP
- Recruiting
St Bartholomew's Hospital - PPDS
London, Greater London, EC1A 7BE
- Recruiting
Royal Brompton Hospital
London, SW3 6NP
- Recruiting
Perth Royal Infirmary
Perth, Scotland, PH1 1NX
- Recruiting
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Greece6 sites, 6 recruiting
- Recruiting
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, 681 00
- Recruiting
Thoracic General Hospital of Athens I SOTIRIA
Athens, Anatoliki Attiki, 115 27
- Recruiting
University General Hospital - General Hospital of West Attica H Agia Varvara
Chaïdári, Anatoliki Attiki, 124 62
- Recruiting
General Hospital of Thessaloniki ''G. Papanikolaou''
Exochi, Thessaloniki, 570 10
- Recruiting
PAGNI-University General Hospital of Heraklion
Heraklion, Irakleio, 715 00
- Recruiting
University General Hospital of Ioannina
Ioannina, Ioannina, 455 00
Taiwan6 sites, 6 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, 50006
- Recruiting
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 80756
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
- Recruiting
Taichung Veterans General Hospital
Taichung, 407219
- Recruiting
National Taiwan University Hospital
Taipei, 106
- Recruiting
Taipei Veterans General Hospital
Taipei, 112201
Chile5 sites, 5 recruiting
- Recruiting
Centro de Investigacion Curicó
Curicó, Maule Region, 3341643
- Recruiting
CEC SpA
Ñuñoa, Santiago Metropolitan, 7750495
- Recruiting
Biocinetic Servicios Medicos Ltda
Santiago, Santiago Metropolitan, 8320000
- Recruiting
Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
Viña del Mar, Valparaiso, 2520000
- Recruiting
Centro de Investigaciones Clinicas Vina del Mar
Viña del Mar, Valparaiso, 2520000
France5 sites, 5 recruiting
- Recruiting
CHU Amiens Picardie - Site Sud
Amiens, Somme, 80054
- Recruiting
AP-HP - Hopital Avicenne
Bobigny, Seine-Saint-Denis, 93000
- Recruiting
Hospices Civils de Lyon - Groupement Hospitalier Est
Bron, 69500
- Recruiting
CHU de Nice-Hôpital Pasteur
Nice, Alpes-Maritimes, 6001
- Recruiting
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, 35000
New Zealand4 sites, 4 recruiting
- Recruiting
Canterbury Respiratory Research Group
Christchurch, Canterbury, 8001
- Recruiting
Greenlane Clinical Centre
Epsom, Auckland, 1051
- Recruiting
Health New Zealand - Te Whatu Ora - Waikato Hospital
Hamilton, Waikato Region, 3240
- Recruiting
Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS
Papatoetoe, Auckland, 2025
Peru4 sites, 4 recruiting
- Recruiting
Clinica Internacional - PPDS
Lima, Lima Province, 15001
- Recruiting
Clinica Ricardo Palma - PPDS
Lima, Lima Province, 15046
- Recruiting
Clinica Providencia - PPDS
San Miguel, Lima region, 15001
- Recruiting
Clinica San Pablo Surco
Surco, Lima region, 15555
Poland4 sites, 4 recruiting
- Recruiting
Centrum Medycyny Oddechowej Mroz sp. j.
Bialystok, Podlaskie Voivodeship, 15-044
- Recruiting
SpiroClinic
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079
- Recruiting
PULMAG s.c.
Sosnowiec, Silesian Voivodeship, 41-208
- Recruiting
Alergopneuma Centrum Medyczne - Swidnik
Świdnik, Lublin Voivodeship, 21-040
Serbia4 sites, 4 recruiting
- Recruiting
University Clinical Center of Serbia - Koste Todorovica - PPDS
Belgrade, 11000
- Recruiting
Institute of Pulmonary Diseases of Vojvodina
Kamenitz, Syrmia, 21204
- Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
- Recruiting
University Clinical Center Nis
Niš, 18 000
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, 29010
- Recruiting
CHUS-Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010
Portugal1 site, 1 recruiting
- Recruiting
ULS de São José, EPE - Hospital de Santa Marta
Lisbon, 1169-024
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.
Read the detailed description
This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and PK of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis with or without background treatment. The treatment period is 26 weeks and full study duration is up to 36 weeks including Screening and Follow-Up. Approximately 324 participants will be enrolled into one of three treatment arms, PIPE-791 Dose A, PIPE-791 Dose B, or placebo.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- PIPE-791 Dose A, PIPE-791 Dose B, Placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, PIPE 791, Pulmonary Fibrosis, IPF, ILD, Interstitial lung disease
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPE-791 Dose ADrug
Also called PIPE-791
Participants will receive a daily oral dose of PIPE-791 in tablet form
PIPE-791 Dose BDrug
Also called PIPE-791
Participants will receive a daily oral dose of PIPE-791 in tablet form
PlaceboDrug
Participants will receive a daily oral dose of matching Placebo in tablet form
| Study group | Role | What they receive |
|---|---|---|
| PIPE-791 Dose A | Experimental | Not described Receives: Drug: PIPE-791 Dose A |
| PIPE-791 Dose B | Experimental | Not described Receives: Drug: PIPE-791 Dose B |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in forced vital capacity (FVC) (mL)
Measured: From baseline to Week 26
Secondary outcomes (7)
To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE)
Measured: From baseline to Week 30
Relative change in FVC (mL)
Additional assessment of disease progression through lung function measurements
Measured: From baseline to Week 26
Proportion of participants with a ≥10% absolute decline in percent predicted FVC (ppFVC)
Measured: From baseline to Weeks 12 and Week 26
Time to first ≥10% absolute decline in ppFVC
Measured: From baseline to time of first ≥10% absolute decline, up to Week 26
Absolute change in ppFVC
Additional assessment of disease progression through lung function measurements
Measured: From baseline to Week 26
Relative change in ppFVC
Additional assessment of disease progression through lung function measurements
Measured: From baseline to Week 26
Change in quantitative CT-derived lung fibrosis burden on HRCT
Additional assessment of disease progression through imaging
Measured: From baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start8 Jan 2026
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Contineum Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mudiaga O Sowho, MD, MPH, Study director, Contineum Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284459
- Sponsor's protocol ID
- CTX-791-201
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No