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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502954-15-00 | Other Identifier | EU-CT |
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| Name | Class |
|---|---|
| DevPro Biopharma | INDUSTRY |
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The study will evaluate the efficacy and safety of axatilimab in participants with IPF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axatilimab | Experimental | Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period. |
|
| Placebo | Placebo Comparator | Participants will receive placebo every 2 weeks during the 26-week Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axatilimab | Drug | Administered as intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL]) | Baseline through Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression | Disease progression is defined as absolute FVC percent predicted decline of ≥10%, or occurrence of lung transplant or all-cause death prior to Week 26. | Baseline through Week 26 |
| Annualized rate of decline in FVC percent predicted over 26 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Syndax Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| Sunshine Coast University Hospital |
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| Placebo | Other | Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient. |
|
| Baseline through Week 26 |
| Change in St. George's Respiratory Questionnaire (SGRQ) score from Baseline to Week 26 | Baseline, Week 26 |
| Change in diffusion capacity for carbon monoxide (DLco % of predicted, corrected for hemoglobin) from Baseline to Week 26 | Baseline, Week 26 |
| Birtinya |
| Queensland |
| 4575 |
| Australia |
| Wallace Street Specialist Centre | Brisbane | Queensland | 4032 | Australia |
| Mater Misericordiae Ltd | South Brisbane | Queensland | 4101 | Australia |
| Griffith University Clinical Trial Unit | Southport | Queensland | 4222 | Australia |
| Mackay Hospital & Health Service | West Mackay | Queensland | 4740 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Institute for Respiratory Health | Perth | Western Australia | 6009 | Australia |
| OLV Hospital Aalst | Aalst | Oost-Vlaanderen | 9300 | Belgium |
| AZ Groeninge | Kortrijk | West-Vlaanderen | 8500 | Belgium |
| Centre de Recherche Clinique - CHUS | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Dynamic Drug Advancement | Ajax | L1S 2J5 | Canada |
| Thomayer University Hospital | Prague | 140 00 | Czechia |
| CHU Amiens | Amiens | 80054 | France |
| Chu Brest | Brest | 29200 | France |
| CHU Dijon | Dijon | 21000 | France |
| CHU de Rennes | Rennes | 35033 | France |
| Klinikum Konstanz, Innere Medizin, Pneumologie | Konstanz | Baden-Wurttemberg | 78464 | Germany |
| Pneumologisches Studienzentrum München-West | Munich | Bavaria | 81241 | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Klinikum Chemnitz - Zentrum für klinische Studien | Chemnitz | 09116 | Germany |
| Studienzentrum Dr. Keller | Frankfurt am Main | 60389 | Germany |
| Asklepios Lungenklinik Gauting | Gauting | 82131 | Germany |
| RoMed Klinikum Rosenheim | Rosenheim | 83022 | Germany |
| Ospedale Colonnello D'Avanzo | Foggia | Apulia | 71122 | Italy |
| ASST Santi Paolo e Carlo | Milan | Lombardy | 20142 | Italy |
| San Gerardo | Monza | MB | 20900 | Italy |
| Azienda Ospedaliera Universitaria San Luigi Gonzaga | Torino | Orbassano | 10043 | Italy |
| University of Padua | Padova | Padua | 35128 | Italy |
| Azienda Ospedaliera Universitaria Senese | Siena | Tuscany | 53100 | Italy |
| A.O.U. Policlinico "G. Rodolico - San Marco" | Catania | 95123 | Italy |
| Azienda Ospedaliero Universitaria di Careggi | Florence | 50134 | Italy |
| AOU di Modena | Modena | 41124 | Italy |
| AOU Città della Salute e della Scienza di Torino - Molinette | Molinette | Italy |
| ISMETT | Palermo | 90127 | Italy |
| Vitamed Galaj I Cichomski sp.j. | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-079 | Poland |
| Mics Centrum Medyczne Bydgoszcz | Bydgoszcz | Poland |
| Makowskie Centrum medyczne Hamernia Sp zz | Maków Podhalański | 34-220 | Poland |
| Warmia and Mazury Center for Lung Diseases | Olsztyn | 10-357 | Poland |
| Clinica Lavinia Davidescu SRL | Oradea | 410163 | Romania |
| Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara Department of Pneumology | Timișoara | 300310 | Romania |
| Inje University Haeundae Paik Hospital | Haeundae | Busan | 48108 | South Korea |
| Chonnam National University Hospital | Gwangju | Dong-gu | 61469 | South Korea |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul | Eunpyeong-gu | 03312 | South Korea |
| Konkuk University Medical Center | Seoul | Gwangjin-gu | 05030 | South Korea |
| Chung-Ang University Gwangmyeong Hospital | Gyeonggi-do | Gwangmyeong-si | 14353 | South Korea |
| Gachon University Gil Medical Center | Incheon | Namdong-gu | 21565 | South Korea |
| Asian Medical Center | Seoul | Songpa-gu | 05505 | South Korea |
| Jeonbuk National University Hospital | Jeonju | 54907 | South Korea |
| Korea University ANAM Hospital | Seoul | 02841 | South Korea |
| SoonChunHyang University Hospital | Seoul | 04401 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitario Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| University Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Puerta del Mar - Pneumology and Thoracic Surgery Department | Cadiz | 11009 | Spain |
| Giromed Institute | Girona | 17003 | Spain |
| Hospital Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitari Son Espases | Palma de Mallorca | 07120 | Spain |
| Hospital Universitario Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| E-Da Hospital | Kaohsiung City | 824005 | Taiwan |
| Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital | Linkou District | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Royal Papworth Hospital - Clincial Research Facility | Cambridge | Cambridgehsire | CB2 0AY | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | Norfolk | NR4 7UY | United Kingdom |
| Oxford University Hospitals NHS Trust | Oxford | Oxforshire | OX3 7LE | United Kingdom |
| Gannochy Trust Clinical Research Suite | Perth | Scotland | PH11NX | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | W York | LS9 7TF | United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | West Midlands | B15 2WB | United Kingdom |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000711669 | axatilimab |
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