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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02502903 | Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders | PHASE1 | COMPLETED | 122 | — | — | Jul 13, 2015 | Mar 31, 2021 | Apr 25, 2022 | 1 | Austria |
Serious and Non-Serious adverse events probably or possibly attributable to BIVV009
| Arm | Type | Description |
|---|---|---|
| Part A | PLACEBO_COMPARATOR | Single ascending dose (SAD) in NHVs, 7 cohorts, BIVV009 by IV infusion (0.3,1, 3, 10, 30, 60, or 100 mg/kg) or placebo. |
| Part B | PLACEBO_COMPARATOR | Multiple ascending dose (MAD) in NHVs, 2 cohorts, 4 weekly IV doses of BIVV009 (30 or 60mg/kg) or placebo. |
| Part C | EXPERIMENTAL | Multiple dose (MD) in a single cohort of patients with various complement-mediated disorders. All patients in Part C will receive a single IV test dose of BIVV009 of 10 mg/kg followed by 4 weekly doses of 60 mg/kg. |
| Part E | EXPERIMENTAL | Multiple dose (MD) in a single cohort of patients with cold agglutinin disease previously treated with BIVV009. All patients in Part E will receive a single IV test dose at week 0, week 1, and every 2 weeks thereafter until EOT. Patients who weigh less than 75 kg will receive fixed doses of 6.5 grams of BIVV009; patients who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009. Dose will be increased from 6.5g to 7.5g dose level if patients current weight is \>= 75 kg and there is evidence of hematologic breakthrough OR patients current weight is \>= 75 kg and there has been at least a 10 percent increase from the patients last recorded weight. Dose will be decreased from 7.5g to 6.5g for patients whose last weight was \>= 75 kg and current weight decreased to \< 75 kg. Dose decrease will require Sponsor approval. |
| Name | Type | Description |
|---|---|---|
| BIV009 | DRUG | - |
| Placebo | OTHER | - |
Inclusion Criteria: Part A/B: * healthy male or female volunteers, age \>= 18 years old * if female, must be post-menopausal, surgically sterilized, or willing/able to use dual, redundant methods of contraception (e.g., barrier plus oral contraceptives) throughout the study * previously vaccinated...