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P-selectin inhibitor

Inclacumab for Sickle Cell Crisis

Phase 3

Waitlist Available

Research Sponsored by Global Blood Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history. A prior VOC is defined as an acute episode of pain which: Has no medically determined cause other than a vaso-occlusive event, and Results in a visit to a medical facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and Requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1- week 48

Awards & highlights

Study Summary

This trial will study whether inclacumab can reduce the frequency of vaso-occlusive crises in people with sickle cell disease.

Who is the study for?

This trial is for males and females aged 12 or older with sickle cell disease who've had 2-10 pain crises in the past year. They must be on a stable dose of certain medications like hydroxyurea, L-glutamine, or voxelotor for at least 30 days. Those on regular blood transfusions, recent crizanlizumab users, or weighing over 133 kg cannot participate.Check my eligibility

What is being tested?

The study tests inclacumab against a placebo to see if it can reduce painful episodes known as vaso-occlusive crises in people with sickle cell disease. About 240 participants will either receive inclacumab or a placebo randomly.See study design

What are the potential side effects?

While specific side effects are not listed here, inclacumab could potentially cause reactions related to the immune system since it targets P-selectin involved in inflammation and blood cells sticking together.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had 2-10 severe pain episodes related to my condition in the last year, requiring medical attention.

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I have had 2 to 10 episodes of severe pain in the last year.

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I need strong pain medication given through injections or an increase in my oral pain medication.

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I have been on a stable dose of ESA for at least 90 days and will continue it during the study.

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I have been diagnosed with sickle cell disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1- week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1- week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1- week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of VOCs during the 48-week treatment period.

Secondary outcome measures

Incidence of treatment-emergent adverse events (TEAEs).

Number of days of inpatient hospitalization for a VOC during the 48-week treatment period.

Proportion of participants with no VOCs during the 48-week treatment period.

+3 more

Other outcome measures

PD parameter (P-selectin inhibition)

PD parameter (Platelet Leukocyte Aggregation)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: inclacumab, 30 mg/kgExperimental Treatment1 Intervention

Participants will receive inclacumab 30 mg/kg administered IV every 12 weeks

Group II: placeboPlacebo Group1 Intervention

Participants will receive placebo administered IV every 12 weeks.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Global Blood TherapeuticsLead Sponsor

35 Previous Clinical Trials

4,637 Total Patients Enrolled

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,910,200 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,475 Previous Clinical Trials

8,091,314 Total Patients Enrolled

Media Library

Inclacumab (P-selectin inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04935879 — Phase 3

Sickle Cell Disease Research Study Groups: inclacumab, 30 mg/kg, placebo

Sickle Cell Disease Clinical Trial 2023: Inclacumab Highlights & Side Effects. Trial Name: NCT04935879 — Phase 3

Inclacumab (P-selectin inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04935879 — Phase 3

Frequently Asked Questions

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

Are there any documented adverse effects of Inclacumab?

"Given that Inclacumab is a Phase 3 medication, and thus has some data to support its efficacy as well as multiple rounds of safety testing, our team at Power estimates its safety to be a 3."

Answered by AI

What are the most recent findings of other research teams using Inclacumab?

"The first clinical studies involving inclacumab were completed in 2021 at the Organizacion Clinica Bonnadona Prevenir S.A.. A total of 18,281 trials have been completed thus far. There are two active trials currently being conducted; one of these is based out of Bronx, New york."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

2021. "A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04935879.

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