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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518339-12-00 | EU Trial (CTIS) Number |
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The goal of this clinical trial is to learn if the investigational drug CAL101 can help prevent further decline in lung function in adults with Idiopathic Pulmonary Fibrosis.
Researchers will compare CAL101 with placebo to compare change from baseline in forced vital capacity (FVC).
Participants will be randomly assigned to a study group that will receive an IV infusion of either the study medication or placebo about once a month for 6 months.
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CAL101 in participants with IPF, either as standalone treatment or in addition to currently approved antifibrotic treatments..
The study will consist of a 28-days Screening Period, intravenous (IV) infusions of CAL101 or placebo once every 4 weeks over 24 weeks, and a 16 week Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAL101 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAL101 | Drug | Intravenous infusions of CAL101 every 4 weeks over 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in forced vital capacity (FVC) compared to placebo | 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck School of Medicine at USC | Los Angeles | California | 90033 | United States | ||
| National Jewish Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41124966 | Derived | Borchert SV, Hallen J, Hussain RI, Holyer I, Troelsen JT, Klingelhofer J. Development of CAL101-a humanized monoclonal antibody targeting S100A4 to inhibit proinflammatory and profibrotic signaling. J Pharmacol Exp Ther. 2025 Nov;392(11):103722. doi: 10.1016/j.jpet.2025.103722. Epub 2025 Sep 24. |
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| Placebo |
| Drug |
Intravenous infusions of placebo every 4 weeks over 24 weeks |
|
| Denver |
| Colorado |
| 80206 |
| United States |
| Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research | Miami | Florida | 33144 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Pulmonix, LLC | Greensboro | North Carolina | 27403 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| University of Utah Health | Salt Lake City | Utah | 84108 | United States |
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| AP-HP Hopital Avicenne | Bobigny | 93000 | France |
| AP-HP Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| CHU Rennes - Hopital Pontchaillou | Rennes | 35000 | France |
| CHU de Toulouse - Hopital Larrey | Toulouse | 31059 Cedex 9 | France |
| CHRU de Tours - Hôpital Bretonneau | Tours | 37000 | France |
| Azienda Ospedale - Università Padova | Padova | PD | 35128 | Italy |
| Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore | Roma | RM | 00168 | Italy |
| Azienda Ospedaliero Universitaria Senese | Siena | SI | 53100 | Italy |
| Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara | Trieste | TS | 34149 | Italy |
| Azienda Ospedaliero-Universitaria di Modena | Modena | 41124 | Italy |
| AORN - Ospedali dei Colli - Ospedale V. Monaldi | Naples | 80131 | Italy |
| Istituto Clinico Humanitas - Pneumologia 1 | Rozzano | 20089 | Italy |
| Erasmus MC | Rotterdam | South Holland | 3015 GD | Netherlands |
| St. Antonius Ziekenhuis - Locatie Nieuwegein | Nieuwegein | Utrecht | 3435 CM | Netherlands |
| Haukeland University Hospital | Bergen | 5021 | Norway |
| Akershus University Hospital | Lørenskog | 1478 | Norway |
| Oslo University Hospital, Rikshospitalet | Oslo | 0372 | Norway |
| Spitalul Clinic de Pneumoftiziologie ''Leon Daniello'' | Cluj-Napoca | Cluj | 400371 | Romania |
| Spitalul Clinic de Boli Infectioase si Pneumoftiziologie ''Victor Babes'' Craiova | Craiova | Dolj | 200515 | Romania |
| Spitalul Clinic de Boli Infectioase si Pneumoftiziologie dr. Victor Babes Timisoara | Timișoara | Timiș County | 300310 | Romania |
| Institutul de Pneumoftiziologie Marius Nasta | Bucharest | 050159 | Romania |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| University of Health Sciences Gulhane Faculty of Medicine | Ankara | 06010 | Turkey (Türkiye) |
| Uludag University Medical Faculty | Bursa | 16059 | Turkey (Türkiye) |
| Ege University Medical Faculty Hospital | Izmir | 35100 | Turkey (Türkiye) |
| Queen Elizabeth Hospital Birmingham | Birmingham | B15 2GW | United Kingdom |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| NHS Lothian, Edinburgh Royal Infirmary | Edinburgh | EH16 4SA | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| Royal Brompton Hospital | London | SW3 6HP | United Kingdom |
| Manchester University NHS Foundation Trust | Manchester | M23 9QZ | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 7LE | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | SO16 6YD | 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 |
|---|---|
| C552946 | idelalisib |
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