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 ...
Xembify is an investigational therapy being studied for hypogammaglobulinemia, a condition characterized by low antibody levels. It is being evaluated in patients with recurrent or severe infections associated with B-cell chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma. The drug is currently in Phase 3 clinical development.
Xembify is a small molecule being developed to address hypogammaglobulinemia. Its specific molecular target has not been disclosed. The drug is being studied for its ability to prevent infections in patients with recurrent or severe infections linked to certain B-cell malignancies.
Xembify is being developed by Grifols, S.A., a biopharmaceutical company. The company is conducting a Phase 3 clinical trial to evaluate the drug's efficacy and safety in patients with hypogammaglobulinemia and recurrent or severe infections associated with B-cell chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma.
Xembify is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is recruiting participants to assess the drug's efficacy, safety, and pharmacokinetics compared to placebo.
Xembify is being studied in a Phase 3 clinical trial registered as NCT05645107. This randomized, double-blind, placebo-controlled study is evaluating Xembify plus standard medical treatment compared to placebo plus standard medical treatment to prevent infections in participants with hypogammaglobulinemia and recurrent or severe infections associated with B-cell chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma.
Xembify is the drug name used in the ongoing clinical trial. No alternative names have been reported for this investigational therapy. It is being studied under the name Xembify in the Phase 3 trial for hypogammaglobulinemia and related conditions.