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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02977533 | A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis | PHASE1 | COMPLETED | 20 | — | — | Dec 1, 2016 | May 16, 2018 | Apr 25, 2022 | 1 | Germany |
| NCT02282826 | A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis | PHASE1 | COMPLETED | 48 | — | — | Oct 1, 2014 | Mar 1, 2016 | Apr 13, 2016 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| GZ402668 | EXPERIMENTAL | Dose 1 (up to a maximum optional Dose 2) will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration. |
| Placebo | PLACEBO_COMPARATOR | A dose of matching placebo will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration. |
| Dose 1 IV | EXPERIMENTAL | GZ402668 dose 1 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 2 IV | EXPERIMENTAL | GZ402668 dose 2 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 3 IV | EXPERIMENTAL | GZ402668 dose 3 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 3 SC | EXPERIMENTAL | GZ402668 dose 3 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 4 SC | EXPERIMENTAL | GZ402668 dose 4 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 5 SC | EXPERIMENTAL | GZ402668 dose 5 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Placebo SC | PLACEBO_COMPARATOR | placebo subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Placebo IV | PLACEBO_COMPARATOR | placebo intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Name | Type | Description |
|---|---|---|
| GZ402668 | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Placebo | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Acyclovir | DRUG | Pharmaceutical form: tablet Route of administration: oral |
Inclusion criteria : * Male or female adult with a diagnosis of progressive multiple sclerosis (MS) including primary progressive MS, secondary progressive MS, or progressive relapsing MS. * Aged between 18 and 65 years, inclusive. * Body weight greater than 40.0 kg. * Female patients of child bear...