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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524153-14-00 | EU Trial (CTIS) Number |
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The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP.
The study consists of an open label treatment phase where participants will receive empasiprubart for up to 27 months approximately. After the final dose of empasiprubart, participants will enter a safety follow-up period for up to 14 months approximately.
The overall study duration for each participant is up to 43 months.
More information can be found here: clinicaltrials.argenx.com/emlight
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empasiprubart IV | Experimental | Participants will receive empasiprubart IV |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empasiprubart IV | Biological | Intravenous infusions of empasiprubart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Empasiprubart serum concentrations as input for a population PK-driven analysis to determine the effect of age and body size on CL and Vd | CL = Clearance; Vd = apparent volume of distribution. | Up to 8 weeks |
| Free and total C2 levels as input for PK/PD modeling analysis | C2 = complement component 2. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs, SAEs and AESIs | AE = Adverse event ; SAE = Serious adverse event ; AESI = Adverse event of special interest. | Up to 180 weeks |
| Empasiprubart serum concentrations over time | Up to 180 weeks |
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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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| Label | URL |
|---|---|
| Study website | View source |
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| Percentage reductions from baseline of free and total C2 levels over time | C2 = complement component 2. | Up to 180 weeks |
| Incidence of ADA and NAb against empasiprubart in serum | ADA = antidrug antibody(ies); NAb = neutralizing antibody(ies). | Up to 180 weeks |
| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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