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

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Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Multiple Oral Doses of AG-348 in Subjects With Stable Sickle Cell Disease A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared to Placebo in Subjects With Stable Sickle Cell Disease The Effect of Rivaroxaban in Sickle Cell Disease Muscle Function and Its Biological and Physiological Determinants in Sickle Cell Disease Safety of Single Ascending Doses of CSL889 in Adult Patients With Stable Sickle Cell Disease Sickle Cell Disease and CardiovAscular Risk – Red Cell Exchange Trial (SCD-CARRE) Dose-Finding Study of SC411 in Children With Sickle Cell Disease A Pilot Study on Neuroimaging in SCD: Part of The Boston Consortium to Cure Sickle Cell Disease Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain The Brigance Assessment Of Individual Neurodevelopment In 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Inflammation in Adults Living With Sickle Cell Disease Nitric Oxide and Transfusion Therapy for Sickle Cell Patients With Pulmonary Hypertension L-Glutamine Therapy for Sickle Cell Anemia and Sickle ß0 Thalassemia Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS) Web-MAP Intervention for Youth With Sickle Cell Disease Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease Effect of MitoQ on Platelet Function and Reactive Oxygen Species Generation in Patients With Sickle Cell Anemia Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients Carbon Monoxide Levels and Sickle Cell Disease Severity Myeloablative Conditioning, Prophylactic Defibrotide and Haplo AlloSCT for Patients With Sickle Cell Disease Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease – Sickle With Ibuprofen & Morphine Peripheral Blood Stem Cell Collection for Sickle Cell Disease (SCD) Patients Treatment of Sickle Cell Anemia With Stem Cell Transplant Neurovascular Determinants of Cognitive Function in Adults With Sickle Cell Disease Stem Cell Transplantation for Sickle Cell Anemia Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient Safety of Blood Stem Cell Mobilization With Plerixafor in Patients With Sickle Cell Disease Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia N-Acetylcysteine in Patients With Sickle Cell Disease Atorvastatin Therapy to Improve Endothelial Function in Sickle Cell Disease Stem Cell Transplant in Patients With Severe Sickle Cell Disease Study of Blood Platelets in Sickle Cell Disease Clinical and Laboratory Characteristics of Sickle Cell Anemia Patients Admitted With Fever Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil Evaluating Barriers to Stroke Screening and Prevention in Children With Sickle Cell Disease Codeine in Sickle Cell Disease Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease Analysis of T-Cell Immune Reconstitution Following Allogeneic Hematopoietic BMT for Severe SCD Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial A Study of the Efficacy and Safety of ICA-17043 (With or Without Hydroxyurea) in Patients With Sickle Cell Anemia. Inhaled Corticosteroid Use to Prevent Acute Chest Syndrome Recurrence in Children Between 1 and 4 With Sickle Cell Disease: a Feasibility Trial Absorption, Metabolism, and Excretion of a Single Dose of Ferriprox® in Patients With Sickle Cell Disease A Safety Study of Eptifibatide in Patients With Sickle Cell Disease A Study Evaluating the Efficacy and Safety of LentiGlobin BB305 Drug Product in Beta-Thalassemia Major and Sickle Cell Disease Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease The Link Between Anemia and Deficits in Memory and Attention in Individuals With Sickle Cell Disease The Feasibility of the PAINReportIt Guided Relaxation Intervention-INPATIENT Safety and Efficacy of Sodium Nitrite in Sickle Cell Disease Cerebrovascular Reserve Measurements in Sickle Cell Disease Examining the Knowledge, Attitudes, and Beliefs of Sickle Cell Disease Patients, Parents of Patients With Sickle Cell Disease, and Providers Towards the Integration of CRISPR in Clinical Care A New Reagent Assay Examining Natural Parvovirus B19 Infection in Sickle Cell Disease MAP to Provide Access to Crizanlizumab, for Sickle Cell Disease Patients A Pilot Study of Azithromycin Prophylaxis for Acute Chest Syndrome in Sickle Cell Disease Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease Nitric Oxide to Improve Blood Flow in Sickle Cell Disease Risk Clinical Stratification of Sickle Cell Disease in Nigeria, Assessment of Efficacy/Safety of Hydroxyurea Treatment The Efficacy of Jobelyn (Sorghum Bicolor Extract)in the Treatment of Sickle Cell Anemia A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD) Sickle Cell Disease: A Retrospective Chart Review Kidney Function in Sickle Cell Anemia A Multi-Center Study of Riociguat in Patients With Sickle Cell Diseases Sickle Cell Disease Conditioning for Bone Marrow Transplant Study of Beet Juice for Patients With Sickle Cell Anemia Hydroxyurea for the Treatment of Patients With Sickle Cell Anemia Hematopoietic Stem Cell Transplant for Sickle Cell Disease Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503) Music Therapy in Sickle Cell Transition Study Evaluation of Hydroxyurea Plus L-arginine or Sildenafil to Treat Sickle Cell Anemia Vitamin D and Bisphosphonates in the Treatment of Sickle Cell Disease Hypnosis to Manage Pain and Symptoms in Patients With Sickle Cell Disease Exercise-induced Pulmonary Hypertension in Patients With Sickle-cell Anemia Kidney Transplantation in Patients With Sickle Cell Disease Simvastatin (Zocor) Therapy in Sickle Cell Disease MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS) Hydroxyurea for Children and Young Adults With Sickle Cell Disease and Pulmonary Hypertension Omega-3 Fatty Acids in Sickle Cell Disease Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease HLA Haploidentical Bone Marrow Transplant in Patients With Severe Sickle Cell Disease Bone Marrow Transplantation in Treating Children With Sickle Cell Disease Stem Cell Transplant in Sickle Cell Disease and Thalassemia Evaluation of Different Dose Regimens of Aes-103 Given for 28 Days to Subjects With Stable Sickle Cell Disease Pain Management Protocol for Pediatric Sickle Cell Disease Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia Haploidentical Transplantation With Pre-Transplant Immunosuppressive Therapy for Patients With Sickle Cell Disease A Study of Varespladib Infusion in Subjects With Sickle Cell Disease. Sickle Cell Disease and Endothelial Progenitor Cells (EPCs) Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing Vaso-Occlusive Crises Rate in Pediatric Patients With Sickle Cell Disease. Vitamin D Supplementation in Children With Sickle Cell Disease L-Arginine and Sickle Cell Disease Sleep Apnea in Sickle Cell Disease Microvessels and Heart Problems in Sickle Cell Disease Dose-Escalation Study of SCD-101 in Sickle Cell Disease Minimizing Toxicity in HLA-identical Related Donor Transplantation for Children With Sickle Cell Disease Oxygen Therapy and Pregnancy in Sickle Cell Disease A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease A Pilot Study of Chronic Red Blood Cell Transfusion in Sickle Cell Disease-Associated Pulmonary Hypertension Aspirin Prophylaxis in Sickle Cell Disease Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics Novel Cardiac Magnetic Resonance Imaging to Define a Unique Restrictive Cardiomyopathy in Sickle Cell Disease DREPAMASSE Study – Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry Study of Hydroxyurea to Treat Sickle Cell Disease Evaluation of the Prevalence of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease A Phase II Trial of Regadenoson in Sickle Cell Anemia Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease The Role of Endothelin-1 in Sickle Cell Disease Adolescent, Caregiver, and Young Adult Perspectives of the Transition From Pediatric to Adult Care for Sickle Cell Disease: A Preliminary Evaluation of the Sickle Cell Disease Transition Program Long Term Effects of Hydroxyurea Therapy in Children With Sickle Cell Disease Neuropathic Pain in Jamaicans With Sickle Cell Disease Families Taking Control (FTC): Family-based Problem-solving Intervention for Children With Sickle Cell Disease Measurement of Cerebral Blood Flow Using Transcranial Doppler Ultrasound in Children With Sickle Cell Disease Study of a Red Blood Cell Deformability Parameter in Patients With Sickle Cell Disease Sickle Cell Disease Biofluid Chip Technology (SCD BioChip) Sleep Respiratory Disorders Evaluation in Sickle Cell Disease Children SMART Mobile Application Technology Utilization in the Treatment of Sickle Cell Disease Post Day Hospital Discharge Hydroxyurea in Young Children With Sickle Cell Anemia Contraception in Women With Sickle Cell Disease Efficacy of a Decision Aid for Hydroxyurea in Sickle Cell Disease Sickle Cell Disease, Hemechip Transplantation Using Reduced Intensity Approach for Patients With Sickle Cell Disease From Mismatched Family Donors of Bone Marrow Medication Adherence in Youth With Sickle Cell Disease (SCD) The Feasibility of Text Messaging to Assess Secondhand Smoke Exposure Among Youngsters With Cancer or Sickle Cell Disease Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia A Randomized Trial of LOVAZA in Pediatric Sickle Cell Disease (SCD) Stem Cell Transplantation With Identical Donors for Patients With Sickle Cell Disease Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease A Sickle CEll Disease ComplicatioN Trial Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients Effect of Simvastatin Treatment on Vaso-occlusive Pain in Sickle Cell Disease Inflammatory Response to Hydroxyurea Therapy in Sickle Cell Disease Blood Sampling for Research Related to Sickle Cell Disease Pediatric -Adult Care Transition Program of Patients With Sickle Cell Disease Assessment of Algorithm-Based Hydroxyurea Dosing on Fetal Hemoglobin Response, Acute Complications, and Organ Function in People With Sickle Cell Disease Qualitative Survey of Potential Exercise Activity in Adults With Sickle Cell Anemia (SCA) Sickle Cell Anemia in an Arab Bedouin Village in the Northern Israel Non-Myeloablative Bone Marrow Transplant for Patients With Sickle Cell Anemia and Other Blood Disorders Hydroxyurea in the Treatment of Sickle Cell Disease Stem Cell Gene Therapy for Sickle Cell Disease Safety, Pharmacokinetic, and Pharmacodynamic Study of NKTT120 in Adult Patients With Stable Sickle Cell Disease (SCD) A Phase 2 Study of the Effects of 6R-BH4 in Subjects With Sickle Cell Disease State Of The Art Functional Imaging In Sickle Cell Disease Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease Survey in a Population of Sickle Cell Disease Patients to Evaluate the Transition Between the Queen Fabiola Children Hospital and the CHU Brugmann Hospital, and the Quality of the Hospital Care Within the CHU Brugmann Hospital. Study of Ventilatory Mechanics in Patients With Sickle Cell Anemia A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy Ph I/II Study of Allogeneic SCT for Clinically Aggressive Sickle Cell Disease (SCD) Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease MACS Study – Microparticles and Coagulation in Sickle Cell Disease Prasugrel Versus Placebo in Adult Sickle Cell Disease Evaluating the Safety and Effectiveness of Bone Marrow Transplants in Children With Sickle Cell Disease (BMT CTN 0601) PK Study of Ticagrelor in Children Aged Less Than 24 Months, With Sickle Cell Disease (HESTIA4) Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators Therapeutic Application of Intravascular Nitrite for Sickle Cell Disease PK and PD Responses to Oral L-Citrulline in Patients With Sickle Cell Disease Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease Haplo T-Cell Depleted Transplantation in High-Risk Sickle Cell Disease A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease HLA-Identical Sibling Donor Bone Marrow Transplantation for Individuals With Severe Sickle Cell Disease Using a Reduced Intensity Conditioning Regimen Sickle Cell Disease (SCD) Decision Aid Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC) Study of Vitamin D in Children With Sickle Cell Disease Psychometric Evaluation of the IPPAQ in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain Haploidentical Stem Cell Transplant for Patients With Sickle Cell Disease and Prior Stroke or Abnormal Transcranial Ultrasound Sickle Cell Anemia WE CARE Improving Emergency Department Management of Adults With Sickle Cell Disease Transfusion Alternatives Pre-Operatively in Sickle Cell Disease (TAPS) Exploring Adherence Monitoring in Sickle Cell Disease Niacin to Improve Blood Flow in People With Sickle Cell Disease Propanolol and Red Cell Adhesion Non-asthmatic Children Sickle Cell Disease Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease Spectralis HRA+OCT Imaging of the Retina With Autofluorescence in Sickle Cell Disease A Pilot Study of N-acetylcysteine in Patients With Sickle Cell Disease Carbon Monoxide Measurement to Screen for Sickle Cell Disease SALT: Alternative Donor Bone Marrow and Cord Blood Transplantation for High Risk Sickle Cell Disease Safety and Pharmacokinetics of SANGUINATE™ in Sickle Cell Disease (SCD) Patients Cardiovascular Complications of Sickle Cell Disease Bone Marrow Transplantation in Young Adults With Severe Sickle Cell Disease Quantitative MRI for Patients With Sickle Cell Disease Undergoing Hematopoietic Cell Transplant Molecular Phenotyping of Asthma in Sickle Cell Disease Secondary Pulmonary Hypertension in Adults With Sickle Cell Anemia Liver Fibrosis in Sickle Cell Disease Evaluation of the Lung Capillary Blood Volume in Children With Sickle Cell Disease Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia Sickle Cell Disease – Stroke Prevention in Nigeria Trial Exercise Capacity in Pediatric Sickle Cell Anemia A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients Links Between Cognitive Functions and Clinical, Biological and Neuroradiological Outcomes in Adults With Sickle Cell Disease. Phase 1 Study of Zoledronic Acid in Sickle Cell Disease Biological, Genetic and Environmental Involved in the Complications of Sickle Cell Disease Community Health Workers and mHealth for Sickle Cell Disease Care Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease Sleep and Pain in Sickle Cell Disease A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease Gene Transfer for Patients With Sickle Cell Disease Vitamin D3 in Patients With Sickle Cell Disease Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease Risk Factors for Allo-immunization in Sickle Cell Disease Sickle-cell Disease Registry of the GPOH Microvascular Blood Flow in Sickle Cell Anemia Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease

Brief Title

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

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

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Rate of VOCs during the 48-week treatment period.

Secondary Outcome

 Time to first VOC during the 48-week treatment period.

Condition

Sickle Cell Disease

Intervention

Inclacumab

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

240

Start Date

August 31, 2021

Completion Date

October 31, 2023

Primary Completion Date

July 31, 2023

Eligibility Criteria

        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. Participant is male or female, ≥ 12 years of age at the time of informed consent.

          3. 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:

          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.
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 650-822-8728, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04935879

Organization ID

GBT2104-131

Secondary IDs

2020-005286-13

Responsible Party

Sponsor

Study Sponsor

Global Blood Therapeutics


Study Sponsor

, , 


Verification Date

August 2021