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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    240
  • sponsor
    Global Blood Therapeutics
Updated on 14 November 2021
hydroxyurea
narcotics
glutamine
thalassemia
voxelotor

Summary

This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants ( 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

Description

Eligible participants will be administered inclacumab or placebo intravenous (IV) every 12 weeks.

The total duration of treatment for each participant will be 48 weeks.

Participants that complete the study through Week 48 will be provided the opportunity to enroll in an open-label extension (OLE) study.

Details
Condition SICKLE CELL ANEMIA, Vaso-occlusive Crisis, Vaso Occlusive Crisis, Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease
Treatment Placebo, Inclacumab
Clinical Study IdentifierNCT04935879
SponsorGlobal Blood Therapeutics
Last Modified on14 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
\. Participant is male or female, 12 years of age at the time of informed
consent
\. 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. 4. Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study. 5. Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta) must be on a stable dose for at least 30 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study

Exclusion Criteria

Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion)
Participant is taking or has received crizanlizumab (ADAKVEO) within 90 days prior to the Screening Visit
Participant weighs > 133 kg (292 lbs.)
Other protocol-defined Inclusion/Exclusion may apply
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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