Up to approximately 520 participants who have completed a prior inclacumab clinical trial will be enrolled. SCD
Conditions
Interventions
This multicenter, global, open-label extension study is designed to assess the safety of long-term treatment with inclacumab in participants with SCD. The study will be conducted globally and will be
All participants will receive inclacumab 30 mg/kg administered IV Q12W. All infusions of inclacumab will be administered at the study site.
Treatment
Sponsors
Global Blood Therapeutics, Inc.
Eligibility
Sex/Gender
All
Age
12 Years to 90 Years
Inclusion criteria
Inclusion criteria: Participants who meet all the following criteria will be eligible for study enrollment: 1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study. 2. Participant has completed the originating inclacumab study within 30 calendar days of the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related adverse event (AE), but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab. 3. Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1. Note: Female participants who become of childbearing potential during the study must be willing to have a negative urine pregnancy test to remain in the study. 4. If sexually active, female participants of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug. 5. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant’s legal representative or legal guardian and the participant’s assent (where applicable) must be obtained based on local requirement.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following exclusion criteria will not be eligible for study enrollment: 1. Female participant who is breastfeeding or pregnant. 2. Participant had an infusion-related reaction (IRR) in the originating inclacumab clinical study. 3. Participant withdrew consent from the originating inclacumab clinical study. 4. Participant was lost to follow-up from the originating inclacumab clinical study. 5. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: Safety;Timepoints: each visit ;Measure: Incidence of treatment-emergent adverse events (TEAEs).;Name: Safety;Timepoints: each visit ;Measure: Change from Baseline in laboratory assessments (hematology, chemistry, and coagulation).;Name: Safety;Timepoints: each visit ;Measure: Vital signs and physical examination | — |
Contacts
Public ContactAziz Zoghbi
Director of Country Oversight and Manageme nt MENA, Gulf and Africa
Outcome results
None listed