Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Xembify · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| XEMBIFY + Standard Medical Treatment (SMT) | EXPERIMENTAL | Participants will receive a loading dose of 150 milligrams per kilograms per day (mg/kg/day) (Week 1, Days 1 to 5) subcutaneously (SC) for 5 consecutive daily doses followed by biweekly infusions of 300 mg/kg/2-week starting Week 3 (Day 15) through Week 51 (end of Treatment Phase). The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation. |
| Placebo + SMT | PLACEBO_COMPARATOR | Participants will receive sterile 0.9 percent Sodium Chloride Injection (commercially available in the corresponding country) starting at Week 1 (Days 1 to 5) SC for 5 consecutive daily doses followed by biweekly infusions starting at Week 3 (Day 15) through Week 51. The SMT will include the active treatments and the other supportive treatments that the participants will need during their participation. |
| Name | Type | Description |
|---|---|---|
| Xembify | DRUG | SC infusion pump |
| Placebo | DRUG | SC infusion pump |
Inclusion Criteria: * Participants ≥18 years of age at screening visit * Participants with documented and confirmed diagnosis of any of the below diseases: * B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4) * MM ...