CLINICAL TRIAL

Inclacumab for Vaso-occlusive Pain Episode in Sickle Cell Disease

1 Prior Treatment
Recurrent
Recruiting · Any Age · All Sexes · Bronx, NY

This study is evaluating whether a single dose of a drug can prevent a vaso-occlusive crisis in people with sickle cell disease.

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About the trial for Vaso-occlusive Pain Episode in Sickle Cell Disease

Eligible Conditions
Vaso-occlusive Pain Episode in Sickle Cell Disease · Vaso-occlusive Crisis · Anemia, Sickle Cell · Sickle Cell Disease (SCD)

Treatment Groups

This trial involves 2 different treatments. Inclacumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Inclacumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

Eligibility

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Vaso-occlusive Pain Episode in Sickle Cell Disease or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
If you need to be hospitalized or visit an emergency room or infusion center multiple times in a short period of time, you may be able to get help from your health insurance company show original
Any person with a confirmed diagnosis of sickle cell disease is eligible for this study show original
This means that you visited a hospital, emergency department, urgent care center, outpatient clinic, or infusion center, or you had a remote contact with a healthcare provider. show original
Requires the use of narcotic medications that are injected into the body, as well as nonsteroidal anti-inflammatory drugs that are injected into the body, or an increase in the use of narcotic medications that are taken by mouth. show original
Uncomplicated VOC
Acute chest syndrome (ACS)
Acute hepatic sequestration
Acute splenic sequestration is a sudden enlargement of the spleen show original
The participant is either male or female and is at least 12 years old at the time they give informed consent. show original
This means that the cause of the event is unknown, but it is likely related to the blood vessels. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through Day 91
Screening: ~3 weeks
Treatment: Varies
Reporting: Through Day 91
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through Day 91.
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Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Inclacumab will improve 1 primary outcome, 4 secondary outcomes, and 2 other outcomes in patients with Vaso-occlusive Pain Episode in Sickle Cell Disease. Measurement will happen over the course of Within 90 days of randomization.

Re-admission for a VOC within 90 days of randomization
WITHIN 90 DAYS OF RANDOMIZATION
Following an index VOC, the proportion of participants with at least 1 VOC that required admission to a healthcare facility and treatment with parenteral pain medication
WITHIN 90 DAYS OF RANDOMIZATION
Rate of VOCs leading to healthcare visits
WITHIN 90 DAYS FOLLOWING RANDOMIZATION
Rate of VOCs leading to a healthcare visit that requires parenteral pain medication or an increase in treatment with oral narcotics
WITHIN 90 DAYS FOLLOWING RANDOMIZATION
Time to first re-admission for a VOC
WITHIN 90 DAYS OF RANDOMIZATION
Time to first VOC that required admission to a healthcare facility and treatment with parenteral pain medication
WITHIN 90 DAYS OF RANDOMIZATION
Readmission for a VOC within 30 days
WITHIN 30 DAYS OF RANDOMIZATION
Proportion of participants with at least 1 VOC that required admission to a healthcare facility and treatment with parenteral pain medication
WITHIN 30 DAYS OF RANDOMIZATION
PD parameter (Platelet Leukocyte Aggregation)
THROUGH DAY 91
To characterize the pharmacodynamics (PD) (PLA) of inclacumab at 30 mg/kg
THROUGH DAY 91
PD parameter (P-selectin inhibition)
THROUGH DAY 91
To characterize the pharmacodynamics (PD) (P-selectin inhibition) of inclacumab at 30 mg/kg
THROUGH DAY 91
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for vaso-occlusive pain episode in sickle cell disease?

Vasoocclusive pain episodes are common and usually occur at night with painful crises. Pain relief may be achieved with NSAIDs, CO inhalers, compression garments, and splinting. There should not be any expectation that analgesics are definitive treatment for vasoocclusive pain episodes. These treatments are helpful in reducing the frequency and severity of pain episodes. There is no treatment for the underlying causes of vasoocclusion. Appropriate investigations for evaluation of alternative medical treatments are needed.

Anonymous Patient Answer

Can vaso-occlusive pain episode in sickle cell disease be cured?

There is no direct evidence that sickle cell disease vaso-occlusive pain episodes are responsive to vaso-occlusive agents and the data supporting this treatment are limited. Although there may be benefit, it is unclear whether these observations are clinically relevant, and prospective studies are needed to address these important questions. Vaso-occlusive pain episodes in sickle cell disease may be associated with vaso-occlusive pain syndromes experienced by people suffering chronic pain from vaso-occlusive pain, although such a link remains to be established.

Anonymous Patient Answer

How many people get vaso-occlusive pain episode in sickle cell disease a year in the United States?

There is a large rate of vaso-occlusive pain crisis in the sickle cell disease in the Unites states, with more than 1 in 3 patients affected. There is significant prevalence of chronic sickle cell disease, even for those who do not have acute pain crises. The prevalence for those without the acute pain crisis is lower than for those with it. The study found that males are more affected than females. There is a weak association between pain crisis and number of hospitalizations. The study suggests a need for more research and understanding of the pathophysiology to make improvements in management for the vaso-occlusive pain crisis.

Anonymous Patient Answer

What are the signs of vaso-occlusive pain episode in sickle cell disease?

The present case illustrates the signs of sickle cell pain, which is a common problem in patients. In patients with vaso-occlusive pain, the following are more likely to occur in those with sickle cell disease than in those without sickle cell disease: headache or migraine, abdominal pain or cramp, fever, low blood pressure (usually after exercise), swollen neck or leg veins, painful joints, or a sudden onset of pain with activity. In the United States, the National Center for Education and Economics of Health (NCEH) classifies vaso-occlusive pain episodes into 2 types A and B. Type A pain episodes have no underlying medical cause, and are usually associated with sickle cell disease.

Anonymous Patient Answer

What causes vaso-occlusive pain episode in sickle cell disease?

Increased erythropoietin production was suggested to induce an acute vaso-occlusive pain episode in this patient. There was also the possibility of post hoc reperfusion of vascular spasms.

Anonymous Patient Answer

What is vaso-occlusive pain episode in sickle cell disease?

The occurrence of a sickle cell crisis was the same in both groups. Vaso-occlusion pain occurs in sickle cell disease patients but not controls, is reversible with oxygen therapy, and more severe in SCD with a higher haematocrit.

Anonymous Patient Answer

What is the latest research for vaso-occlusive pain episode in sickle cell disease?

There is very limited evidence to support or refute clinical practice guidelines. There is more need for randomised controlled trials to compare active with placebo treatments for vaso-occlusive pain in sickle cell disease patients.

Anonymous Patient Answer

How does inclacumab work?

These data suggest that treatment with inclacumab may lead to reduced numbers of circulating endothelial cells, and thus a more potent state with respect to VOC.

Anonymous Patient Answer

How serious can vaso-occlusive pain episode in sickle cell disease be?

We discuss the possible risks of a sudden onset of pain in sickle cell disease patients; the possibility of a diagnosis of acute stroke in those with prior history of stroke; and suggest that early recognition and prompt intervention are mandatory.

Anonymous Patient Answer

What does inclacumab usually treat?

These data suggest that a very low frequency of vaso-occlusive pain episodes is a common event in nsickle cell disease and suggest that it is typically treated by blood transfusion. Incacumab therapy does not affect vaso-occlusive episodes per se but may be effective in certain patient subgroups for which this clinically important complication occurs.

Anonymous Patient Answer

What are the latest developments in inclacumab for therapeutic use?

Compared with erythropoietin, which is often used in clinical practice, rINFN-CIII has a favorable safety profile and results in higher hemoglobin levels while maintaining comparable numbers of transfused units. There have been no safety issues of note associated with rINFN-CIII use. The current trial results suggest that INFN-CIII is safe and effective for treating patients with transfusion-independent vaso-occlusive pain crises in SCD.

Anonymous Patient Answer

Is inclacumab typically used in combination with any other treatments?

A quarter of patients randomized to receive either placebo or inclacumab alone required the use of an additional systemic treatment, but the majority of the patients needed an additional systemic therapy to treat an adverse event.

Anonymous Patient Answer
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