Approval Probability
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Adjusted LOA
ML Risk
Crizanlizuamb · 1 trial · 1 indication
The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 12. A reduction from baseline indicates improvement in patients.
| Arm | Type | Description |
|---|---|---|
| crizanlizumab + standard of care | EXPERIMENTAL | 5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment. |
| standard of care | ACTIVE_COMPARATOR | Patients in the standard of care alone arm will continue to receive their usual standard of care treatment. |
| Name | Type | Description |
|---|---|---|
| Crizanlizuamb | DRUG | Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab |
| Standard of Care | DRUG | HU/HC (hydroxyurea/hydroxycarbamide) and/or ACE (angiotensin-converting enzyme) inhibitors and/or ARBs (angiotensin-receptor blocker) |
Inclusion Criteria: * Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible) * Patients with eGFR ≥ 45 to ≤ 140 mL/min/1.73 m2 based on CKD EPI formula (patients ≥ 18) or the Creatinine-based "Bedside Schwartz" equation (patients \< 18) * Patients with ACR of ≥ 100 to \< 2000 m...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 5 | PHASE3 | Etavopivat Low dose |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Crizanlizumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | PCV21, 20vPCV |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | CTX001 |
| Agios Pharmaceuticals, Inc. | AGIO | 2 | PHASE2 | Mitapivat |
| Pfizer Inc. | PFE | 1 | PHASE2 | Osivelotor |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE1 | BMS-986470, Famotidine, Pantoprazole |
| Fulcrum Therapeutics, Inc. | FULC | 1 | PHASE2 | Pociredir |
| Beam Therapeutics, Inc. | BEAM | 2 | PHASE1 | BEAM-101 |
| Editas Medicine, Inc. | EDIT | 2 | PHASE1 | EDIT-301 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-3405 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
Crizanlizumab is used for Sickle Cell Disease (SCD), specifically in patients with chronic kidney disease caused by sickle cell disease. It is an investigational small molecule being studied for its effect on kidney function in this patient population.
Crizanlizumab is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.
Crizanlizumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 study has been completed.
Crizanlizumab has one completed Phase 2 clinical trial, identified as NCT04053764. The trial studied the effect of crizanlizumab on kidney function in patients with chronic kidney disease caused by sickle cell disease, enrolling 58 participants across multiple countries.
The Phase 2 trial of crizanlizumab (NCT04053764) was randomized and active-controlled, but it was not double-blind. The study enrolled 58 patients with sickle cell disease and chronic kidney disease.