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The AP13CP02 study is a phase 2, open-label, dose escalation trial to determine how safe and tolerable multiple subcutaneous (SC) injections of APL-9796 are for patients with PH. The study will also assess how effective APL-9796 could be for treating patients with PH and whether the body produces antibodies working against APL-9796.
The trial will be conducted in two parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: in adults with WHO Group 1 PAH. | Experimental | Three (3) APL-9796 dose levels are planned for evaluation using BOIN design. |
|
| Part B (optional): in adults with WHO Group 3 PH-ILD | Experimental | Cohorts will be enrolled sequentially at N=4, at a dose level determined by the Safety Review Committee (SRC) based on data from Part A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APL-9796 | Drug | 3 Cohorts are planned in Part A. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants who experience Treatment-Emergent Adverse Events will be reported which also include the frequency, severity (CTCAE V5.0) and relationship (causality) of AEs | Through study completion (approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the Telemetry Parameters | Telemetry parameter is assessed using Total pulmonary resistance (TPR) | from baseline (CFB) to Day 169 |
| To assess the Telemetry Parameters | Telemetry parameter is assessed using Pulmonary arterial pressures: systolic, diastolic and mean (mPAP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjay Aggarwal, MD | Contact | 781-479-2267 | AP13@apollotx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith/Imperial Hospital | Recruiting | London | London | W12 0HS | United Kingdom |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| APL-9796 |
| Drug |
The decision to initiate optional Part B in WHO Group 3 PH-ILD participants will be made by the Safety Review Committee (SRC). |
|
| from baseline (CFB) to Day 169 |
| To assess Six minute walk test / Six minute walk distance (6MWD) | A 6-minute walk test (6MWT) is assessed per the guidelines of the American Thoracic Society 2003 | from baseline (CFB) to Day 169 |
| To assess NT-proB-type Natriuretic Peptide (NT-proBNP) | The level of NT-proBNP is assessed by blood sample collection and analysis | from baseline (CFB) to Day 169 |
| To assess the Quality of life | Quality of life is assessed using SF-36 questionnaire | from baseline (CFB) to Day 169 |
| To assess the Quality of life | Quality of life is assessed using emPHasis-10 questionnaire | from baseline (CFB) to Day 169 |
| To evaluate the PK of APL-9796 in participants with PH | APL-9796 concentrations in serum | at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508 |
| To evaluate the immunogenicity of APL-9796 in participants with PH. |
| at each visit (approximately every 28 days until day 169), then day 254, day 339 and day 508 |
| Royal United Hospital Bath | Recruiting | Bath | United Kingdom |
| Royal Papworth Hospital | Recruiting | Cambridge | United Kingdom |
| Golden Jubilee Hospital | Recruiting | Clydebank | United Kingdom |
| Royal Brompton Hospital | Recruiting | London | United Kingdom |
| Sheffield Teaching Hospitals | Recruiting | Sheffield | United Kingdom |
| D002318 |
| Cardiovascular Diseases |