About THRIVE 131

About Sickle Cell Disease

Have questions? Contact the Clinical Trial Information Center at THRIVEstudy@gbt.com

The THRIVE-131 Trial


THRIVE-131 is a clinical research study evaluating the safety and efficacy of inclacumab, an investigational study drug for the potential treatment related to sickle cell disease. This trial is being conducted to help address the need for therapies for sickle cell disease.

Last updated: Month X, 2022



Overview

Condition

Sickle Cell Disease

Age

16+

16 and Older

Countries

17

17 Countries

Status

Actively Recruiting

Find out if the THRIVE-131 Study is right for you.



Summary

In this study, researchers are looking at the safety and efficacy of inclacumab, a potential treatment related to sickle cell disease (SCD). Clinical studies are conducted to learn about the effects of investigational drugs. The studies are the most important way researchers can confirm that a new drug or treatment is safe and effective.



About the Drug

Inclacumab is an investigational study drug related to sickle cell disease.



About the Trial

The THRIVE-131, phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in approximately 240 adult and adolescent participants (≥ 16 years of age) with SCD. Participants will be randomized to receive inclacumab or placebo.

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.*

*Please contact THRIVEstudy@gbt.com if you have any questions.



What to Do Next?

Inclacumab is an investigational study drug related to sickle cell disease.

  Am I eligible?

Find out if you are eligible to participate in the THRIVE-131 study.



Dates


Study Duration:
October 2021 to October 2023

Total Duration per Participant:
48 weeks


Trial Locations


CONNECTICUT

University of Connecticut

Farmington, CT 06030

GBT2104-131

GBT2104-131

WASHINGTON, DC

Children's National Hospital

Washington, DC 20010

GBT2104-131

GBT2104-131

MASSACHUSETTS

Brigham and Women’s Hospital

Boston, MA 02215

GBT2104-131

GBT2104-131

NEW YORK

Jacobi Medical Center

Bronx, NY 10461

GBT2104-131

GBT2104-131

NEW YORK

Erie County Medical Center

Buffalo, NY 14215

GBT2104-131

GBT2104-131

ILLINOIS

University of Illinois at Chicago

Chicago, IL 60612

GBT2104-131

GBT2104-131

ILLINOIS

Rush University Medical Center

Chicago, IL 60612

GBT2104-131

GBT2104-131

MICHIGAN

University of Michigan

Ann Arbor, MI 48109

GBT2104-131

GBT2104-131

ALABAMA

University of South Alabama Children's and Women's Hospital

Mobile, AL 36604

GBT2104-131

GBT2104-131

ARKANSAS

Arkansas Children's Hospital

Little Rock, AR 72202

GBT2104-131

GBT2104-131

FLORIDA

University of South Florida

Tampa, FL 33606

GBT2104-131

GBT2104-131

NORTH CAROLINA

Duke University Medical Center

Durham, NC 27710

GBT2104-131

GBT2104-131

TENNESSEE

St Jude Children's Research Hospital

Memphis, TN 38105

GBT2104-131

GBT2104-131

TEXAS

University of Texas Health Science Center at Houston

Houston, TX 77030

GBT2104-131

GBT2104-131

ARIZONA

Phoenix Children’s Hospital

Phoenix, AZ 85016

GBT2104-131

GBT2104-131

CALIFORNIA

UCSF Benioff Children's Hospital

Oakland, CA 94609

GBT2104-131

GBT2104-131

CALIFORNIA

UC Irvine Medical Center

Orange, CA 92868

GBT2104-131

GBT2104-131





About Sickle Cell Disease


Overview
Symptoms & Treatment


Red blood cells are responsible for carrying oxygen throughout the body. In a person living with sickle cell, some red blood cells change shape and become sickled, or banana shaped. The sickling process begins with hemoglobin, the part of the red blood cell that carries oxygen. When cells sickle, they can break down and there are fewer red blood cells to carry oxygen to all parts of the body. This can cause serious, long-term complications. Sickle cell is always causing damage in the body, even when pain might not be felt.

STATS

It is estimated that:

100K

Americans affected
by SCD

1 in 365

Black or African-American babies are born with SCD

~20%

of people living with SCD usually receive their care in an emergency room

SDC is a genetic, hereditary disease

Requires medical diagnosis

Lab tests or imaging always required

Chronic: lifelong

For informational purposes only. Consult your local medical authority for advice.
Content ources:  National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention

SYMPTOMS

Pain areas: in the joints

Pain types: can be sudden in the chest, can include vaso-occlusive crises (VOCs)

Whole body: dizziness, fatigue, low oxygen in the body, or malaise

Urinary: inability to make concentrated or dilute urine or blood in urine

Also common: abnormal breakdown of red blood cells, delayed development, inflamed fingers or toes, pallor, shortness of breath, or yellow skin and eyes

A vaso-occlusive crisis (VOC) is defined as an acute episode of pain that:

  • has no medically determined cause other than a vaso-occlusive event, and
  • results in a visit to a medical facility (hospitalization, 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 non-steroidal anti-inflammatory drugs (NSAIDS), or an increase in treatment with oral narcotics.

TREATMENT

Management of sickle cell is usually aimed at avoiding pain episodes, like VOCs, relieving symptoms and preventing complications. Treatments might include medications and blood transfusions. Vaccinations and penicillin can be used to help prevent life-threatening infections.

For informational purposes only. Consult your local medical authority for advice. Content source: Mayo Clinic

Contact the Clinical Trial Information Center

Would you like to know more?
Contact us at THRIVEstudy@gbt.com


Find out if the THRIVE-131 Study is right for you