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This study aims to see how the body reacts to empasiprubart, administered using an autoinjector (AI). The study will also look at other effects of empasiprubart, how it works in the body, and if it is safe.
The study consists of 2 parts: parts A and B. In part A, eligible participants will be randomized to receive empasiprubart SC AI via abdomen, empasiprubart SC AI via thigh, or empasiprubart IV (intravenously). In part B, eligible participants will be randomized to receive empasiprubart SC AI via abdomen or empasiprubart IV.
Participants from part A will be in the study for approximately up to 37 weeks . Participants from part B will be in the study for up to approximately 43 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label treatment period (part A): empasiprubart SC AI (via abdomen) | Experimental | Participants randomized to receive empasiprubart SC AI via abdomen. |
|
| Open-label treatment period (part A): empasiprubart SC AI (via thigh) | Experimental | Participants randomized to receive empasiprubart SC AI via thigh. |
|
| Open-label treatment period (part A): empasiprubart IV | Experimental | Participants randomized to receive empasiprubart IV. |
|
| Open-label treatment period (part B): empasiprubart SC AI | Experimental | Participants randomized to receive empasiprubart IV and empasiprubart SC AI. |
|
| Open-label treatment period (part B): empasiprubart IV | Experimental | Participants randomized to receive empasiprubart IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| empasiprubart SC AI | Biological | Subcutaneous injection of empasiprubart via Autoinjector (AI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV | aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous | Up to 33 weeks |
| aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV | aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous | Up to 33 weeks |
| Ctrough at week 8 | Ctrough = trough concentration | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| empasiprubart Cmax | Cmax = maximum observed concentration | Up to 33 weeks |
| AUCw4-8 over time | AUCw4-8 = area under the concentration-time curve from week 4 to week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Coppieters, MD | Contact | 857-350-4834 | clinicaltrials@argenx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences | Recruiting | Mount Royal | Quebec | H3P 3P1 | Canada |
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| empasiprubart IV | Biological | Intravenous infusion of empasiprubart |
|
| Up to 39 weeks |
| Cavg over time | Cavg = average concentration | Up to 39 weeks |
| Ctrough over time | Ctrough = trough concentration | Up to 39 weeks |
| Percentage change from baseline in free C2 and total C2 over time | C2 = complement component 2 | Up to 33 weeks (Part A) + up to 39 weeks (Part B) |
| Incidence of ADA against empasiprubart in serum | ADA = antidrug antibody(ies) | Up to 33 weeks (Part A) + up to 39 weeks (Part B) |
| Incidence of AEs, SAEs, and AEs leading to empasiprubart discontinuation | AE=adverse event; SAE=serious adverse event | Up to 33 weeks (Part A) + up to 39 weeks (Part B) |