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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509371-16-00 | Other Identifier | EU CT Number |
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The study met futility criteria at pre-planned interim analysis, showing no clinical efficacy of the investigational drug. Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study.
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Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3915393 | Experimental | Participants will receive GSK3915393 |
|
| Placebo | Placebo Comparator | Participants will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3915393 | Drug | GSK3915393 will be administered. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change from Baseline in Forced Vital Capacity (FVC) (milliliters [mL]) at Week 26 | Baseline and at Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change from Baseline in Forced Vital Capacity (mL) at Weeks 4, 8, 12 and 18 | Baseline and at Week 4, Week 8, Week 12 and Week 18 | |
| Absolute Change from Baseline in Percent Predicted Forced Vital Capacity (%) at Weeks 4, 8, 12, 18 and 26 | Baseline and at Week 4, Week 8, Week 12, Week 18 and Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
Prior/Concomitant Therapy-
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Newport Beach | California | 92663 | United States | ||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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This is a placebo-controlled parallel group study.
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This will be a double-blind study with respect to allocation of GSK3915393 or placebo to participants.
| Drug |
Placebo will be administered. |
|
| Number of Participants Achieving Relative Decline from Baseline in FVC (mL) Less than or Equal to (≤) 5 Percent (%) at Week 26 | Baseline and at Week 26 |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 26 |
| Number of Participants with Clinically Important Findings in Vital Signs | Baseline and up to Week 26 |
| Number of Participants with Clinically Important Findings in Electrocardiogram (ECG) | Baseline and up to Week 26 |
| Number of Participants with Clinically Important Findings in Hematology | Baseline and up to Week 26 |
| Number of Participants with Clinically Important Findings in Hepatobiliary Parameters | Baseline and up to Week 26 |
| Number of Participants with Clinically Important Findings in Clinical Chemistry | Baseline up to Week 26 |
| Maximum observed concentration (Cmax) of GSK3915393 in IPF Participants | At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour post-dose) |
| Area under the time-concentration curve (AUC) from Zero (pre-dose) to 4 hours post-dose sample (AUC0-4 hour) of GSK3915393 | At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour post-dose) |
| Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC-inf) of GSK3915393 | At Week 2 (pre-dose, and 0.5, 1, 1.5, 2, 3 and 4 hour post-dose) |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| GSK Investigational Site | St. Petersburg | Florida | 33704 | United States |
| GSK Investigational Site | Ann Arbor | Michigan | 48109-5360 | United States |
| GSK Investigational Site | Rochester | Minnesota | 55905 | United States |
| GSK Investigational Site | New York | New York | 10065 | United States |
| GSK Investigational Site | Wilmington | North Carolina | 28401 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37204 | United States |
| GSK Investigational Site | Cypress | Texas | 77429 | United States |
| GSK Investigational Site | Buenos Aires | C1426ABP | Argentina |
| GSK Investigational Site | Ciudad Autonoma de Bueno | C1207AAP | Argentina |
| GSK Investigational Site | Florida | B1602DQD | Argentina |
| GSK Investigational Site | La Plata | 1900 | Argentina |
| GSK Investigational Site | Mendoza | M5500CCG | Argentina |
| GSK Investigational Site | Rosario | S2000DBS | Argentina |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| GSK Investigational Site | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| GSK Investigational Site | Ajax | Ontario | L1S 2J5 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8N 4A6 | Canada |
| GSK Investigational Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| GSK Investigational Site | La Tronche | 38700 | France |
| GSK Investigational Site | Paris | 75018 | France |
| GSK Investigational Site | Pessac | 33604 | France |
| GSK Investigational Site | Rennes | 35000 | France |
| GSK Investigational Site | Rouen | 76000 | France |
| GSK Investigational Site | Toulouse | 31059 | France |
| GSK Investigational Site | Essen | 45293 | Germany |
| GSK Investigational Site | Hanover | 30173 | Germany |
| GSK Investigational Site | Heidelberg | 69126 | Germany |
| GSK Investigational Site | Wuppertal | 42283 | Germany |
| GSK Investigational Site | Catania | 95123 | Italy |
| GSK Investigational Site | Monza MB | 20900 | Italy |
| GSK Investigational Site | Naples | Italy |
| GSK Investigational Site | Padova | 35128 | Italy |
| GSK Investigational Site | Perugia | 06132 | Italy |
| GSK Investigational Site | Pisa | 56124 | Italy |
| GSK Investigational Site | Roma | 00168 | Italy |
| GSK Investigational Site | Sassari | 07100 | Italy |
| GSK Investigational Site | Torrette AN | Italy |
| GSK Investigational Site | Eindhoven | 5623 EJ | Netherlands |
| GSK Investigational Site | Rotterdam | 3015 CE | Netherlands |
| GSK Investigational Site | Bialystok | 15-044 | Poland |
| GSK Investigational Site | Lodz | 90-153 | Poland |
| GSK Investigational Site | Poznan | 60-569 | Poland |
| GSK Investigational Site | Barcelona | 08907 | Spain |
| GSK Investigational Site | Barcelona | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Oviedo | 33011 | Spain |
| GSK Investigational Site | Pozuelo de AlarcOn Madr | 28223 | Spain |
| GSK Investigational Site | Santander | 39011 | Spain |
| GSK Investigational Site | Seville | 41013 | Spain |
| GSK Investigational Site | Edinburgh | EH16 4SA | United Kingdom |
| GSK Investigational Site | Leeds West Yorkshire | LS9 7TF | United Kingdom |
| GSK Investigational Site | London | SW3 6HP | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2026 |
| 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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