Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

NCT07284459 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CTX-791-201
• Study Type: interventional
• Target: 324
• Locations: 8 countries
• Sites: 57

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; PIPE 791; Pulmonary Fibrosis; IPF; ILD; Interstitial lung disease

Outcome Measures

Primary Outcomes (1)

• Absolute change in forced vital capacity (FVC) (mL)

  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)

  From baseline to Week 30

• Relative change in FVC (mL)

  From baseline to Week 26

• Proportion of participants with a ≥10% absolute decline in percent predicted FVC (ppFVC)

  From baseline to Weeks 12 and Week 26

• Time to first ≥10% absolute decline in ppFVC

  From baseline to time of first ≥10% absolute decline, up to Week 26

• Absolute change in ppFVC

  From baseline to Week 26

Study Arms (3)

PIPE-791 Dose A

EXPERIMENTAL

Drug: PIPE-791 Dose A

PIPE-791 Dose B

EXPERIMENTAL

Drug: PIPE-791 Dose B

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PIPE-791 Dose B DRUG

Participants will receive a daily oral dose of PIPE-791 in tablet form

Also known as: PIPE-791

PIPE-791 Dose B

Placebo DRUG

Participants will receive a daily oral dose of matching Placebo in tablet form

Placebo

PIPE-791 Dose A DRUG

Participants will receive a daily oral dose of PIPE-791 in tablet form

Also known as: PIPE-791

PIPE-791 Dose A

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Contineum Therapeutics: lead

Study Sites (57)

Instituto de Especialidades de la Salud Rosario - Clínica del Tórax

Rosario, Santa Fe Province, S2000DBS, Argentina

RECRUITING

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Santa Fe Province, S2000DEJ, Argentina

RECRUITING

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

RECRUITING

CIMER-Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province, T4000CBC, Argentina

RECRUITING

IPR-Investigaciones en Patologías Respiratorias

San Miguel de Tucumán, Tucumán Province, T4000IAP, Argentina

RECRUITING

Centro Modelo de Cardiología-Laprida 554

San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina

RECRUITING

STAT Research S.A.

Buenos Aires, C1023AAB, Argentina

RECRUITING

Consultorios Médicos Organización del Buen Ayre SRL

Buenos Aires, C1425FVH, Argentina

RECRUITING

Centro Médico Dra de Salvo - Fundacion Respirar - PPDS

Buenos Aires, C1426ABP, Argentina

RECRUITING

Instituto de Medicina Respiratoria - IMER

Córdoba, X5003DCE, Argentina

RECRUITING

IbaMedica

Santa Fe, S3000ASF, Argentina

RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Institute for Respiratory Health

Midland, Western Australia, 6056, Australia

RECRUITING

TrialsWest Pty Ltd

Spearwood, Western Australia, 6163, Australia

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Toronto General Hospital

Toronto, Ontaria, M5G 2C4, Canada

RECRUITING

Dynamic Drug Advancement Ltd.

Ajax, Ontario, L1S 2J5, Canada

RECRUITING

Dr. Anil Dhar Medicine Professional Corporation

Windsor, Ontario, N8X 5A6, Canada

RECRUITING

Centre d'investigation Clinique Mauricie

Trois-Rivières, Quebec, G8T 7A1, Canada

RECRUITING

Shamir Medical Center

Be’er Ya‘aqov, Central District, 7033001, Israel

RECRUITING

Meir Medical Center

Kafr Saba, Central District, 4428164, Israel

RECRUITING

Rabin Medical Center - PPDS

Petah Tikva, Central District, 4941492, Israel

RECRUITING

The Chaim Sheba Medical Center - PPDS

Ramat Gan, Central District, 5262100, Israel

RECRUITING

Kaplan Medical Center

Rehovot, Central District, 7661041, Israel

RECRUITING

Hillel Yaffe Medical Center

Hadera, Haifa District, 3820302, Israel

RECRUITING

Hadassah Medical Center- Ein Kerem - PPDS

Jerusalem, Jerusalem, 9112001, Israel

RECRUITING

Assuta Ashdod University Medical Center

Ashdod, Southern District, 7747629, Israel

RECRUITING

The Barzilai University Medical Center

Ashkelon, Southern District, 7830604, Israel

RECRUITING

Shaare Zedek Medical Center

Jerusalem, Yerushala, 9103102, Israel

RECRUITING

Tel Aviv Sourasky Medical Center Ichilov - PPDS

Tel Aviv, 6423906, Israel

RECRUITING

Greenlane Clinical Centre

Epsom, Auckland, 1051, New Zealand

RECRUITING

Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS

Papatoetoe, Auckland, 2025, New Zealand

RECRUITING

Canterbury Respiratory Research Group

Christchurch, Canterbury, 8001, New Zealand

RECRUITING

Health New Zealand - Te Whatu Ora - Waikato Hospital

Hamilton, Waikato Region, 3240, New Zealand

RECRUITING

Institute of Pulmonary Diseases of Vojvodina

Kamenitz, Syrmia, 21204, Serbia

RECRUITING

University Clinical Center of Serbia - Koste Todorovica - PPDS

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

University Clinical Center Nis

Niš, 18 000, Serbia

RECRUITING

The Catholic University of Korea - Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong District, 03312, South Korea

RECRUITING

The Catholic University of Korea, Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, 14647, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Severance Hospital Yonsei University Health System

Seoul, Seodaemun, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

Soon Chun Hyang University Hospital

Seoul, Yongsan-gu, 04401, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, 21565, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 2841, South Korea

RECRUITING

NIHR Leicester Biomedical Research Centre - Glenfield Hospital

Leicester, England, LE3 9QP, United Kingdom

RECRUITING

St Bartholomew's Hospital - PPDS

London, Greater London, EC1A 7BE, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

RECRUITING

Perth Royal Infirmary

Perth, Scotland, PH1 1NX, United Kingdom

RECRUITING

Birmingham Heartlands Hospital

Birmingham, B3 3HX, United Kingdom

RECRUITING

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mudiaga O Sowho, MD, MPH

  Contineum Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Nikki Nepomuceno

CONTACT

858-333-5280; nnepomuceno@contineum-tx.com

Marietta Franco

CONTACT

650-450-6634; mfranco@contineum-tx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 16, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); AR (11); SE (4); GB (7); IL (11); AU (7); NZ (4); KR (8)