Phase 3
N=241
A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
Sickle Cell Disease · Vaso-occlusive Pain Episode in Sickle Cell Disease · Vaso-occlusive Crisis
Bottom Line
View on ClinicalTrials.gov: NCT04935879 ↗Enrolled (actual)
241
Serious AEs
20.9%
Results posted
Dec 2025
Primary outcome: Primary: Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48 — 1.49; 1.58 Events per 48 weeks — p=0.6967
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Inclacumab (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48 |
1.49; 1.58 | 0.6967 |
| SECONDARY Time to First VOC Through Week 48 |
28.7; 21.6 | 0.4298 |
| SECONDARY Time to Second VOC Through Week 48 |
NA; NA | — |
| SECONDARY Percentage of Participants With no VOCs Through Week 48 |
36.0; 25.7 | 0.0912 |
| SECONDARY Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48 |
0.85; 0.83 | 0.9246 |
| SECONDARY Rate of Inpatient Hospitalization Days for a VOC Through Week 48 |
4.96; 5.37 | =0.8263 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
87; 97 | — |
Summary
This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.
Eligibility Criteria
Inclusion Criteria
- Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype).
Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening.
- Participant is male or female, ≥ 12 years of age at the time of informed consent.
- Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history. A prior VOC is defined as an acute episode of pain which:
- Has no medically determined cause other than a vaso-occlusive event, and
- Results in a visit to a medical facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and
- Requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics.
- Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.
- Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.
Exclusion Criteria
- Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).
- Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to the Screening Visit
- Participant weighs > 133 kg (292 lbs.).
Other protocol-defined Inclusion/Exclusion may apply.
Data sourced from ClinicalTrials.gov (NCT04935879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.