Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIV009 · 1 trial · 4 indications
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...
BIV009 is an investigational small molecule being developed for Bullous Pemphigoid (BP), a blistering skin condition. It is also being studied in other complement-mediated disorders. The drug is currently in Phase 1 clinical development and is not yet approved.
BIV009 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical trials and is not yet approved for any indication.
BIV009 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, which included healthy volunteers and patients with complement-mediated disorders.
BIV009 has one completed Phase 1 clinical trial, registered as NCT02502903. This study evaluated the safety, tolerability, and activity of BIV009 in healthy volunteers and patients with complement-mediated disorders, including Bullous Pemphigoid, Cold Agglutinin Disease, Warm Autoimmune Hemolytic Anemia, and End-stage Renal Disease.
BIV009 is also known as BIVV009. The drug is being developed by Sanofi and is currently in Phase 1 clinical trials for Bullous Pemphigoid and other complement-mediated disorders. It is an investigational small molecule and has not been approved.