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alemtuzumab GZ402673 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| alemtuzumab (subcutaneous injection) | EXPERIMENTAL | Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. |
| alemtuzumab (intravenous infusion) | EXPERIMENTAL | Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine \[loratadine, cetirizine, dexchlorpheniramine\], paracetamol, acyclovir) will be administered prior alemtuzumab administration. |
| Name | Type | Description |
|---|---|---|
| Acyclovir | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| Methylprednisolone | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| alemtuzumab GZ402673 | DRUG | Pharmaceutical form:solution for infusion Route of administration: intravenous |
| Paracetamol | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| Loratadine | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| Ceterizine | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| Dexchlorpheniramine | DRUG | Pharmaceutical form:tablet Route of administration: oral |
Inclusion criteria: * Male or female adults with a diagnosis of Multiple Sclerosis (MS) based on 2010 revision of McDonald criteria. * Diagnosis of progressive MS including primary progressive MS and secondary progressive MS. * Age ≥18 years. * Signed informed consent form. * Covered by a health in...
Alemtuzumab GZ402673 is an investigational monoclonal antibody developed by Sanofi for progressive multiple sclerosis. It is a Phase 1 candidate in the neurology therapeutic area. The compound is a CD52 inhibitor and has been studied in a single completed clinical trial. It is not described as approved for any use.
Alemtuzumab GZ402673 is being studied for progressive multiple sclerosis. The only recorded trial enrolled patients with progressive multiple sclerosis, and it was conducted in Spain. The drug remains investigational and is not described as approved for treating multiple sclerosis or any other condition.
Alemtuzumab GZ402673 targets CD52. It is a monoclonal antibody that acts as an inhibitor of CD52, a protein found on the surface of certain immune cells. This CD52-directed binding is the basis for its investigation in progressive multiple sclerosis, an immune-mediated neurological condition.
Sanofi develops alemtuzumab GZ402673. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the sponsor of the clinical program studying this CD52-targeting monoclonal antibody in progressive multiple sclerosis.
Alemtuzumab GZ402673 is in Phase 1 development. The program has one completed Phase 1 trial, and no active trials are recorded. Because it is still in clinical development, alemtuzumab GZ402673 is investigational and is not described as FDA approved for any indication.
Alemtuzumab GZ402673 has been studied in trial NCT02583594, titled A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis. That Phase 1 trial is completed, enrolled 24 participants, was randomized and controlled, and was conducted in Spain in adults 18 years and older.