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...
| 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 |
Inclacumab is an investigational small molecule being studied for the treatment of Sickle Cell Disease, specifically for patients experiencing vaso-occlusive crises. It is being evaluated to assess its safety and efficacy in reducing these painful episodes. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Inclacumab is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical research to evaluate the drug's potential in treating Sickle Cell Disease, with the most recent trial being a Phase 3 study.
Inclacumab is in Phase 3 clinical development. A Phase 3 trial, NCT04935879, has been completed, evaluating the drug in 241 participants with Sickle Cell Disease experiencing vaso-occlusive crises. As an investigational drug, Inclacumab has not yet received FDA approval and remains under clinical investigation.
Inclacumab has one completed clinical trial, NCT04935879, a Phase 3 study assessing its safety and efficacy in participants with Sickle Cell Disease experiencing vaso-occlusive crises. The trial enrolled 241 participants across multiple countries, including the United States, Brazil, France, and Nigeria. It was a randomized, double-blind, placebo-controlled study.
Inclacumab is a distinct investigational small molecule developed by Pfizer. No alternative names for this drug have been reported in clinical trial records. It is being studied specifically for Sickle Cell Disease and vaso-occlusive crises, and is not known to be identical to any other marketed or investigational agent.