THRIVE-131: A study to potentially reduce VOCs in sickle cell

verified Patient-friendly certified What is this?
The Sickle Cell 101 research team in collaboration with study investigator have reviewed this information to ensure it is patient-friendly and accurate.

About the Study

The THRIVE-131 study will evaluate the safety and efficacy of an investigational therapy called inclacumab to decrease vaso-occlusive crises in participants with sickle cell disease. 

Over the course of 48 weeks, eligible participants will be given inclacumab or placebo intravenously every 12 weeks to determine if this investigational drug therapy can improve the life of individuals living with sickle cell disease by decreasing the number of painful vaso-occlusive crises (VOCs).

Read more

Participation information

Age

12

Gender

All

Genotypes

SCD type SS
SCD type SC
SCD type Sβ0 thalassemia
SCD type Sβ+ thalassemia

Study Information

Study type

Clinical

Interventions

Inclacumab, placebo

Phase

3

Compensation

The study doctor will discuss potential compensation with participant

Am I Eligible?

Requirements

You may be eligible to participate in this study if you:
  • Have a confirmed diagnosis of sickle cell disease
  • Have had between 2 and 10 vaso-occlusive crises over the past 12 months. A VOC is defined as pain which:
    • Has no cause other than a VOC; and 
    • Results in a visit to a hospital, emergency department, urgent care center, outpatient clinic, or infusion center or results in a call to a doctor about the VOC; and 
    • Requires IV pain medication, or an increase in treatment with oral pain medication (eg. opioids/narcotics). 
  • Are taking other drugs for sickle cell diseases, at a stable dose for at least 30 to 90 days before the screening visit and expect to stay on that same dose for the entire study. 
  • Participants who can get pregnant may be eligible to participate in the study if they have a negative pregnancy test prior to the Screening Visit and agree to use highly effective methods to prevent getting pregnant for the duration of the study and 165 days following the conclusion of the study.

Restrictions

You can't participate in this study if you:
  • Receive monthly red blood cell transfusions
  • Receive or have received crizanlizumab (ADAKVEO®) within 90 days prior to the Screening Visit.
  • Weigh more than 292 lbs.

Study point of contact

Global Blood Therapeutics
[email protected]
ClinicalTrials.gov Enroll in this Study
Last updated September 23, 2022