Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02583594 | A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis | PHASE1 | COMPLETED | 24 | — | — | Dec 6, 2015 | Mar 1, 2021 | Mar 10, 2021 | 1 | Spain |
| 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...