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This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy, safety, and tolerability of 200 mg twice daily (BID) of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBT-877 | Experimental | 200 mg twice daily (BID)of BBT-877 in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib). |
|
| Placebo | Placebo Comparator | 200 mg twice daily (BID)of Placebo in patients with IPF, with or without AF approved background therapies (pirfenidone or nintedanib). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBT-877 | Drug | BBT-877 24 weeks + Follow-up 4 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| In patients with IPF by measuring the reduction in forced vital capacity (FVC) in mL decline compared to placebo | Change from baseline in FVC (in mL). | After 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| In patients with IPF by measuring the reduction in forced vital capacity (FVC) % predicted decline compared to placebo | Change from baseline in FVC (%). | After 24 weeks of treatment |
| To evaluate the effect of on diffusing capacity of lung for carbon monoxide (DLCO) of BBT-877 compared to placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates P.A. | Phoenix | Arizona | 85006-2611 | United States | ||
| Southern Arizona VA Health Care System - NAVREF - PPDS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40404183 | Derived | Maher T, Song JW, Kramer MR, Lancaster L, Corte TJ, Yun J, Kim K, Cho J, Sather LF, George PM, Devaraj A, Jung JH, Jung S. Phase 2 study design and analysis approach for BBT-877: an autotaxin inhibitor targeting idiopathic pulmonary fibrosis. BMJ Open Respir Res. 2025 May 22;12(1):e003038. doi: 10.1136/bmjresp-2024-003038. |
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| Drug |
Placebo 24 weeks + Follow-up 4 weeks |
|
Change from baseline compared to placebo in DLCO |
| After 24 weeks of treatment |
| To evaluate the effect on functional exercise capacity (measured by the 6-Minute Walk Test [6MWT]) of BBT-877 compared to placebo | Change from baseline in functional exercise capacity as measured by change in 6-minute walk distance assessed by the 6MWT | After 24 weeks of treatment |
| To assess the change in IPF impacts from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo | Change in overall respiratory health as measured by the St. George's Hospital Respiratory Questionnaire (SGRQ) total score from baseline and Change in overall IPF impacts as measured by the L-IPF total score from baseline | after 24 weeks of treatment |
| To assess the change in IPF symptoms from the patient perspective after 24 weeks of treatment of BBT-877 compared to placebo | Change in overall IPF symptoms as measured by the L-IPF total score from baseline | after 24 weeks of treatment |
| To evaluate potential effect of BBT-877 on pharmacokinetics (PK)of each antifibrotic(AF)in patients with IPF | Pre-dose and 4 hr-post dose of plasma concentrations | 0, 4, 12, 24 weeks of treatment |
| To evaluate the potential effect of each AF on PK of BBT-877 in patients with IPF | Pre-dose and 4 hr-post dose of plasma concentrations. | 0, 4, 12, 24 weeks of treatment |
| To assess the safety of BBT-877 compared to placebo | The investigator will be asked to provide an assessment of the severity of the AE using the following categories: Mild: Usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate: Usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the patient. Severe: Interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention. | over 24 weeks |
| Tucson |
| Arizona |
| 85723-0001 |
| United States |
| Keck Medical Center of USC | Los Angeles | California | 90033 | United States |
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1207 | United States |
| National Jewish Health Main Campus | Denver | Colorado | 80206-2761 | United States |
| St. Francis Medical Institute - Clinedge | Clearwater | Florida | 33765 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Central Florida Pulmonary Group PA | Orlando | Florida | 32803-5443 | United States |
| Augusta University | Augusta | Georgia | 30912-0004 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611-2993 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153-3328 | United States |
| The Lung Research Center, LLC | Chesterfield | Missouri | 63017-3632 | United States |
| Hannibal Regional Healthcare System-HRMG-Hannibal | Hannibal | Missouri | 63401-6890 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-8900 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37204 | United States |
| Premier Pulmonary Critical Care & Sleep Medicine | Denison | Texas | 75020 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Royal Brisbane & Women's Hospital | Herston | Queensland | 4006 | Australia |
| Institute for Respiratory Health | Nedlands | Western Australia | 6009 | Australia |
| Meir Medical Center | Kfar Saba | Central District | 44281 | Israel |
| Lady Davis Carmel Medical Center | Haifa | Haifa District | 34362 | Israel |
| Hadassah Medical Center | Jerusalem | Jerusalem | 91120 | Israel |
| Tel Aviv Sourasky Medical Center | Ashkelon | Southern District | 78278 | Israel |
| Sheba Medical Center | Ramat Gan | Tel Aviv | 52621 | Israel |
| Barzilai Medical Center | Petah Tikva | 4910000 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Centrum Dentystyczno Lekarskie Promedica Joanna Markiewicz | Będzin | Silesian Voivodeship | 42-500 | Poland |
| Vitamed Galaj i Cichomski sp.j. | Bydgoszcz | 85-681 | Poland |
| Soon Chun Hyang University Hospital Seoul | Cheonan | Chungcheongnam-do | 31151 | South Korea |
| Samsung Medical Center | Seoul | Gangnam-gu | 06351 | South Korea |
| The Catholic University of Korea, Bucheon St. Mary's Hospital | Bucheon-si | Gyeonggi-do | 14647 | South Korea |
| CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | 13497 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Myongji Hospital | Goyang-si | Gyeonggido | 10475 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Gachon University Gil Medical Center | Namdong | Incheon | 21565 | South Korea |
| Korea University Anam Hospital | Seoul | Seongbuk-gu | 02841 | South Korea |
| The Catholic University of Korea - Eunpyeong St. Mary's Hospital | Yeongdeungpo-dong | Seoul | 07345 | South Korea |
| Asan Medical Center | Seoul | Songpa-gu | 05505 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Severance Hospital Yonsei University | Seoul | 03722 | South Korea |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 26, 2025 | Sep 11, 2025 | 19 | ||
| Sep 14, 2025 | Oct 1, 2025 | 20 |
| 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 |
|---|---|
| C000723735 | ATX inhibitor BBT-877 |
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