Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pepinemab · 1 trial · 1 indication
TEAEs are defined as Adverse events (AEs) with onset after date-time of first dose, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP.
| Arm | Type | Description |
|---|---|---|
| pepinemab 40mg/kg | EXPERIMENTAL | The study drug, pepinemab, will be administered via monthly intravenous infusions. |
| Placebo | PLACEBO_COMPARATOR | .A placebo control will be administered via monthly intravenous infusions. |
| Name | Type | Description |
|---|---|---|
| Pepinemab | DRUG | Pepinemab is a humanized IgG4 monoclonal antibody. The antibody is formulated at 20 mg/mL in 20 mM Sodium Acetate buffer, pH 5.4, containing 130 mM Sodium Chloride and 0.02% Polysorbate 80 |
| Placebo | DRUG | Placebo consists of formulation buffer only which is 20 mM Sodium Acetate buffer, pH 5.4, containing 130 mM Sodium Chloride and 0.02% Polysorbate 80 |
Inclusion 1. Written informed consent from the participant and legally acceptable representative (trial partner). 2. Have a reliable and competent trial partner who must have a close relationship with the participant, who has face to face contact at least three days a week for a minimum of ten waki...
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