Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Inclacumab · 1 trial · 3 indications
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. The rate of VOC was defined as number of VOC events per 48 weeks and presented in this outcome measure.
| Arm | Type | Description |
|---|---|---|
| inclacumab, 30 mg/kg | EXPERIMENTAL | Participants will receive inclacumab 30 mg/kg administered IV every 12 weeks |
| placebo | PLACEBO_COMPARATOR | Participants will receive placebo administered IV every 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Inclacumab | DRUG | Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion. |
| Placebo | DRUG | Placebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug |
Inclusion Criteria: 1. Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype). Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening. 2. Part...
Top 12 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 6 | PHASE3 | Etavopivat |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Crizanlizumab, OTQ923, ITU512 |
| Agios Pharmaceuticals, Inc. | AGIO | 3 | PHASE3 | Mitapivat, Tebapivat |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | PCV21, rilzabrutinib |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | CTX001 |
| Pfizer Inc. | PFE | 1 | PHASE2 | Osivelotor |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE3 | L-Citrulline |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE1 | BMS-986470 |
| Fulcrum Therapeutics, Inc. | FULC | 1 | PHASE2 | Pociredir |
| Beam Therapeutics, Inc. | BEAM | 2 | PHASE1 | BEAM-101 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-3405 |
| Editas Medicine, Inc. | EDIT | 2 | PHASE1 | EDIT-301 |
Inclacumab is an investigational monoclonal antibody being studied to reduce vaso-occlusive crises in people with sickle cell disease. It was tested in a Phase 3 trial in participants aged 12 years and older who were experiencing vaso-occlusive pain episodes, including vaso-occlusive crisis.
Inclacumab targets SELP, also known as P-selectin, and acts as an antagonist. By blocking P-selectin, the antibody is designed to interfere with the cell adhesion processes involved in vaso-occlusive crises in sickle cell disease.
Inclacumab is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 3 clinical study of the drug in sickle cell disease.
Inclacumab is in Phase 3 development. It is investigational and has not been approved by the FDA. The Phase 3 study evaluating it in sickle cell disease has been completed.
Inclacumab was evaluated in the Phase 3 trial NCT04935879, titled A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises. The completed trial enrolled 241 participants across the United States, Brazil, Colombia, Egypt, France, Kenya, Lebanon, Nigeria, Oman, Saudi Arabia, Tanzania, and Turkey.
The Phase 3 trial NCT04935879 was a randomized, double-blind, placebo-controlled study. It enrolled 241 participants aged 12 years and older with sickle cell disease who were experiencing vaso-occlusive crises, and it has been completed.