THRIVE-131 Study: A study to potentially reduce VOCs in sickle cell
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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, both through intravenous (IV) 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).
This study is currently recruiting study participants in Atlanta, Georgia; Boston, Massachusetts; Ann Arbor, Michigan; Tripoli, Lebanon, Nini Hospital. If you live in other locations, please contact the study point of contact below to see if you can enroll in this study at a different time.
Study point of contact
| Supriya Rao | |
| [email protected] |
Locations
3 USA sites
1 Lebanon site
Age
12 years and older
Genotypes
All types of SCD
Study type
Clinical trial
Gender
All
Compensation
Yes
participation requirements
A person CAN be eligible to participate in this study if they:
- 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.
participation restrictions
A person CANNOT be eligible to participate in this study if they:
- 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.