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A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Exp

Zahra Pakbaz


A Study On:

  • Blood - Hematologic

Status:

  • Open

Eligibility

12 Years and older (Child, Adult, Older Adult)
Sickle Cell Disease
Vaso-occlusive Pain Episode in Sickle Cell Disease
Vaso-occlusive Crisis

Interested in joining this trial?

Official Title

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Details

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.


Eligibility

You can join if...

Inclusion Criteria:

  1. Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype).
  2. Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening.
  3. Participant is male or female, greater than or equal to 12 years of age at the time of informed consent.
  4. 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: a) Has no medically determined cause other than a vaso-occlusive event, and; b) 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; c) Requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics.
  5. 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.
  6. 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:

  1. Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).
  2. Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to the Screening Visit
  3. Participant weighs > 133 kg (292 lbs.).
    Other protocol-defined Inclusion/Exclusion may apply.

Get in touch with our study team