Trials / Terminated
TerminatedNCT05348915
A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease
An Open-label Extension Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (SCD). Participants in this study will have completed a prior study of inclacumab.
Detailed description
The study will include approximately 520 adult and adolescent participants (≥ 12 years of age) with SCD. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inclacumab | Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion. |
Timeline
- Start date
- 2022-03-29
- Primary completion
- 2025-11-07
- Completion
- 2025-11-07
- First posted
- 2022-04-27
- Last updated
- 2025-12-17
Locations
50 sites across 10 countries: United States, Brazil, Colombia, Kenya, Lebanon, Nigeria, Oman, Saudi Arabia, Tanzania, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05348915. Inclusion in this directory is not an endorsement.