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IgPro20 · 1 trial · 2 indications
Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score). The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
| Arm | Type | Description |
|---|---|---|
| IgPro20 low dose | EXPERIMENTAL | - |
| IgPro20 high dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| IgPro20 (low dose) | BIOLOGICAL | 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization: 0.2 g/kg body weight (low dose arm) |
| Placebo | BIOLOGICAL | 2% human albumin administered by weekly SC infusions during the SC treatment period of the study. |
| IgPro10 | BIOLOGICAL | 10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during Restabilization Period of the study and/or as Rescue Therapy during SC Treatment Period for subjects with a CIDP relapse. |
| IgPro20 (high dose) | BIOLOGICAL | 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization: 0.4 g/kg body weight (high dose arm) |
Inclusion Criteria: * Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010. * An IVIG treatment during the last 8 weeks prior to enrollment. * Age ≥18 years. * Written informed consent for study participation obta...
IgPro20 is an investigational monoclonal antibody being developed for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a neurological condition. It is administered subcutaneously and is currently in Phase 3 clinical development. The drug is not yet approved and remains under investigation for this indication.
IgPro20 is being developed by Icon Plc, a biopharmaceutical company traded on the NASDAQ under the ticker ICLR. The company is conducting clinical trials to evaluate the drug's safety and efficacy for Chronic Inflammatory Demyelinating Polyneuropathy.
IgPro20 is in Phase 3 clinical development for Chronic Inflammatory Demyelinating Polyneuropathy. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug remains under clinical investigation.
IgPro20 has one completed Phase 3 clinical trial, identified as NCT01545076. This randomized, double-blind, placebo-controlled study enrolled 208 participants with Chronic Inflammatory Demyelinating Polyneuropathy across multiple countries, including the United States, Australia, Belgium, Canada, and Japan.
IgPro20 is a subcutaneous immunoglobulin formulation being studied for Chronic Inflammatory Demyelinating Polyneuropathy. The completed clinical trial NCT01545076 evaluated treatment with subcutaneous immunoglobulin (IgPro20) in this condition, indicating the drug is a subcutaneous form of immunoglobulin therapy.