A Study to Evaluate the Long-Term Safety of Inclacumab Administered to Participants with Sickle Cell Disease

Phase 1

Active, not recruiting

• Conditions: Sickle Cell Disease; MedDRA version: 21.0Level: PTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2020-005289-32-IT
• Lead Sponsor: GLOBAL BLOOD THERAPEUTICS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

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 days prior to 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 childbearing 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 use highly effective methods of contraception until 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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 482
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Additional objectives are to evaluate the incidence of vaso-occlusive crises (VOCs), hospitalizations, missed work/school days, red blood cell (RBC) transfusions, and quality of life (QoL) with long-term use of inclacumab.;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable;Main Objective: The primary objective of this study is to evaluate the long-term safety of every 12 week dosing of inclacumab in participants with sickle cell disease (SCD) that have completed a prior inclacumab clinical trial.