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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIPE-791 Dose A | Experimental |
| |
| PIPE-791 Dose B | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIPE-791 Dose A | Drug | Participants will receive a daily oral dose of PIPE-791 in tablet form |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in forced vital capacity (FVC) (mL) | From baseline to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Additional assessment of disease progression through lung function measurements |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Additional inclusion and exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikki Nepomuceno | Contact | 858-333-5280 | nnepomuceno@contineum-tx.com | |
| Marietta Franco | Contact | 650-450-6634 | mfranco@contineum-tx.com |
| Name | Affiliation | Role |
|---|---|---|
| Mudiaga O Sowho, MD, MPH | Contineum Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IPR-Investigaciones en Patologías Respiratorias | Recruiting | San Miguel de Tucumán | Tucumán Province | T4000IAP | Argentina |
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| PIPE-791 Dose B | Drug | Participants will receive a daily oral dose of PIPE-791 in tablet form |
|
|
| Placebo | Drug | Participants will receive a daily oral dose of matching Placebo in tablet form |
|
| 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 | Additional assessment of disease progression through lung function measurements | From baseline to Week 26 |
| Relative change in ppFVC | Additional assessment of disease progression through lung function measurements | From baseline to Week 26 |
| Change in quantitative CT-derived lung fibrosis burden on HRCT | Additional assessment of disease progression through imaging | From baseline to Week 26 |
| Centro Modelo de Cardiología-Laprida 554 | Recruiting | San Miguel de Tucumán | Tucumán Province | T4000IFL | Argentina |
| STAT Research S.A. | Recruiting | Buenos Aires | C1023AAB | Argentina |
| Consultorios Médicos Organización del Buen Ayre SRL | Recruiting | Buenos Aires | C1425FVH | Argentina |
| Centro Médico Dra de Salvo - Fundacion Respirar - PPDS | Recruiting | Buenos Aires | C1426ABP | Argentina |
| IbaMedica | Recruiting | Santa Fe | S3000ASF | Argentina |
| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
| The Prince Charles Hospital | Recruiting | Chermside | Queensland | 4032 | Australia |
| Austin Health | Recruiting | Heidelberg | Victoria | 3084 | Australia |
| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Institute for Respiratory Health | Recruiting | Midland | Western Australia | 6056 | Australia |
| TrialsWest Pty Ltd | Recruiting | Spearwood | Western Australia | 6163 | Australia |
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Toronto General Hospital | Recruiting | Toronto | Ontaria | M5G 2C4 | Canada |
| Dynamic Drug Advancement Ltd. | Recruiting | Ajax | Ontario | L1S 2J5 | Canada |
| Dr. Anil Dhar Medicine Professional Corporation | Recruiting | Windsor | Ontario | N8X 5A6 | Canada |
| Centre d'investigation Clinique Mauricie | Recruiting | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Shamir Medical Center | Recruiting | Be’er Ya‘aqov | Central District | 7033001 | Israel |
| Meir Medical Center | Recruiting | Kafr Saba | Central District | 4428164 | Israel |
| Rabin Medical Center - PPDS | Recruiting | Petah Tikva | Central District | 4941492 | Israel |
| The Chaim Sheba Medical Center - PPDS | Recruiting | Ramat Gan | Central District | 5262100 | Israel |
| Kaplan Medical Center | Recruiting | Rehovot | Central District | 7661041 | Israel |
| Hillel Yaffe Medical Center | Recruiting | Hadera | Haifa District | 3820302 | Israel |
| Hadassah Medical Center- Ein Kerem - PPDS | Recruiting | Jerusalem | Jerusalem | 9112001 | Israel |
| Assuta Ashdod University Medical Center | Recruiting | Ashdod | Southern District | 7747629 | Israel |
| The Barzilai University Medical Center | Recruiting | Ashkelon | Southern District | 7830604 | Israel |
| Shaare Zedek Medical Center | Recruiting | Jerusalem | Yerushala | 9103102 | Israel |
| Tel Aviv Sourasky Medical Center Ichilov - PPDS | Recruiting | Tel Aviv | 6423906 | Israel |
| Greenlane Clinical Centre | Recruiting | Epsom | Auckland | 1051 | New Zealand |
| Aotearoa Clinical Trials Trust - Middlemore Hospital - PPDS | Recruiting | Papatoetoe | Auckland | 2025 | New Zealand |
| Canterbury Respiratory Research Group | Recruiting | Christchurch | Canterbury | 8001 | New Zealand |
| Health New Zealand - Te Whatu Ora - Waikato Hospital | Recruiting | Hamilton | Waikato Region | 3240 | New Zealand |
| Institute of Pulmonary Diseases of Vojvodina | Recruiting | Kamenitz | Syrmia | 21204 | Serbia |
| University Clinical Center of Serbia - Koste Todorovica - PPDS | Recruiting | Belgrade | 11000 | Serbia |
| University Clinical Center Kragujevac | Recruiting | Kragujevac | 34000 | Serbia |
| The Catholic University of Korea - Eunpyeong St. Mary's Hospital | Recruiting | Seoul | Eunpyeong District | 03312 | South Korea |
| The Catholic University of Korea, Bucheon St. Mary's Hospital | Recruiting | Bucheon-si | Gyeonggi-do | 14647 | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | Seodaemun | 03722 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | Seoul | 06351 | South Korea |
| Soon Chun Hyang University Hospital | Recruiting | Seoul | Yongsan-gu | 04401 | South Korea |
| Gachon University Gil Medical Center | Recruiting | Incheon | 21565 | South Korea |
| Korea University Anam Hospital | Recruiting | Seoul | 2841 | South Korea |
| NIHR Leicester Biomedical Research Centre - Glenfield Hospital | Recruiting | Leicester | England | LE3 9QP | United Kingdom |
| Southampton General Hospital | Recruiting | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Royal Infirmary of Edinburgh | Recruiting | Edinburgh | Scotland | EH16 4SA | United Kingdom |
| Perth Royal Infirmary | Recruiting | Perth | Scotland | PH1 1NX | United Kingdom |
| Birmingham Heartlands Hospital | Recruiting | Birmingham | B3 3HX | United Kingdom |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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