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The goal of this clinical trial is to learn if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy. It will also learn about the safety of ripertamab. The main questions it aims to answer are:
Does ripertamab reduce the risk of recurrence in patients? What medical problems do participants have when taking ripertamab? Researchers will compare ripertamab to a placebo (a look-alike substance that contains no drug) to see if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy.
Participants will:
A single intravenous infusion of drug ABC or placebo. Visit the clinic for checkups and tests during W1, W2, W4, W8, W12 Keep a diary of their symptoms and the number of times they undergo rescue therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ripertamab | Drug | On Day 1 of the treatment period, an intravenous infusion of Ripertamab at a dose of 375 mg/m² body surface area will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time to first increase of ≥1 point in the aINCAT score compared to baseline. | Within 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| Placebo | Drug | On Day 1 of the treatment period, an intravenous infusion of Placebo at a dose of 375 mg/m² body surface area will be administered. |
|
| 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 |