A Phase 3 interventional study of Inclacumab and Placebo in Sickle Cell Disease, Vaso-occlusive Crisis and Vaso-occlusive Pain Episode in Sickle Cell Disease, sponsored by Pfizer. Terminated at 59 sites in 14 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This Phase 3 study will assess the safety and efficacy of a single dose of inclacumab, a P-selectin inhibitor, for a vaso-occlusive crisis (VOC) after an index VOC in participants with sickle cell disease (SCD). Participants will be randomized to receive either inclacumab or placebo.
The study will include approximately 280 adult and adolescent participants (≥ 12 years of age) with SCD.
Eligible participants will be administered inclacumab or placebo intravenous (IV) as a single dose.
Participants that complete the study through Day 90 will be provided the opportunity to enroll in an open-label extension (OLE) study.
1,125 studies on the registry are indexed under Anemia, Sickle Cell; 239 are open to participants now.
This study's enrollment of 72 is above the median of 40 across 762 interventional studies indexed under Anemia, Sickle Cell.
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Participant has an index VOC. The index VOC is any VOC that required admission to a healthcare facility and treatment with parenteral pain medication. An admission for the index VOC includes:
for an acute episode of pain with no other cause other than a vaso- occlusive event that includes the following:
Participant has experienced between 2 and 10 VOCs within the 12 months prior to Screening as determined by documented medical history. The index VOC is not to be considered as one of the 2 to 10 events. A prior VOC is defined as an acute episode of pain that:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion may apply.
Inclacumab 30 mg/kg administered intravenously (IV)
Drug: Inclacumab
Placebo administered IV
Drug: Placebo
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.
Placebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug.
Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomization
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for \>= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. An acute episode of pain with no other cause other than a vaso-occlusive event included: uncomplicated VOC, acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD.
Time frame: Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91])
Time to First VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomization
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. Time to first VOC that required admission to a healthcare facility and treatment with parenteral pain medication within 90 days was defined as the time between randomization date and onset date of first VOC event. For participants who did not experience a protocol-defined VOC within 90 days of randomization, time to first VOC was censored at the end of their time at risk (participant's end of study date or Study Day 91, whichever was earlier). An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for \>= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. Kaplan-Meier method used for analysis.
Time frame: Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91]) or censored day, whichever occurred earlier
Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 30 Days of Randomization
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for \>= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. An acute episode of pain with no other cause other than a vaso-occlusive event included: uncomplicated VOC, acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD.
Time frame: Within 30 days of randomization (randomization happened on Day 1 [Day 1 to Day 31])
Rate of VOCs Leading to a Healthcare Visit That Requires Parenteral Pain Medication or an Increase in Treatment With Oral Narcotics Within 90 Days Following Randomization
VOC leading to a healthcare visit was defined as VOC at (hospital, emergency room, clinic visit, or remote contact with a healthcare provider) that required parenteral pain medication (e.g., parenteral narcotic agents or parenteral nonsteroidal anti-inflammatory drugs \[NSAIDs\]), or an increased treatment with oral narcotics. Complicated VOCs included acute chest syndrome (ACS),hepatic sequestration, splenic sequestration, and priapism. For each participant, the time period at risk for evaluation of VOCs was from date of randomization to the participant's end of study date or study Day 91, whichever was earlier. In this outcome measure adjusted rates of VOCs (percentages) reported were based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline hydroxyurea use (yes, no). All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD.
Time frame: Within 90 days of randomization (randomization happened on Day 1 [Day 1 to Day 91])
In this study, participants with sickle cell disease (SCD), aged greater than or equal to (\>=) 12 years were randomized to receive either inclacumab or placebo for reducing the frequency of re-admissions due to vaso-occlusive crisis (VOC) after an index VOC.
| Milestone | Inclacumab 30 mg/kg | Placebo |
|---|---|---|
| Started | 37 | 35 |
| Completed | 34 | 33 |
| Not completed | 3 | 2 |
| Withdrew: Other | 2 | 1 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Adverse event | 1 | 0 |
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for \>= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. An acute episode of pain with no other cause other than a vaso-occlusive event included: uncomplicated VOC, acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD.
| Percentage of participants | Inclacumab 30 mg/kg | Placebo |
|---|---|---|
| Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomization | 45.4 ± 28.7 | 37.5 ± 20.7 |
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. Time to first VOC that required admission to a healthcare facility and treatment with parenteral pain medication within 90 days was defined as the time between randomization date and onset date of first VOC event. For participants who did not experience a protocol-defined VOC within 90 days of randomization, time to first VOC was censored at the end of their time at risk (participant's end of study date or Study Day 91, whichever was earlier). An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for \>= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD. Kaplan-Meier method used for analysis.
| Days | Inclacumab 30 mg/kg | Placebo |
|---|---|---|
| Time to First VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 90 Days of Randomization | NA (NA to NA) | NA (NA to NA) |
A VOC was a complication of SCD characterized by vaso-occlusion presenting as recurrent pain episodes. An admission for a VOC included a hospital admission, or an admission to an emergency room, observation unit, or infusion center for \>= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. An acute episode of pain with no other cause other than a vaso-occlusive event included: uncomplicated VOC, acute chest syndrome, hepatic sequestration, splenic sequestration, or priapism. All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD.
| Percentage of participants | Inclacumab 30 mg/kg | Placebo |
|---|---|---|
| Percentage of Participants With at Least 1 VOC That Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication Within 30 Days of Randomization | 8.2 ± 0.0 | 25.0 ± 9.6 |
VOC leading to a healthcare visit was defined as VOC at (hospital, emergency room, clinic visit, or remote contact with a healthcare provider) that required parenteral pain medication (e.g., parenteral narcotic agents or parenteral nonsteroidal anti-inflammatory drugs \[NSAIDs\]), or an increased treatment with oral narcotics. Complicated VOCs included acute chest syndrome (ACS),hepatic sequestration, splenic sequestration, and priapism. For each participant, the time period at risk for evaluation of VOCs was from date of randomization to the participant's end of study date or study Day 91, whichever was earlier. In this outcome measure adjusted rates of VOCs (percentages) reported were based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline hydroxyurea use (yes, no). All on-study VOCs were adjudicated by an independent, blinded VOC Adjudication Committee comprised of experts in SCD.
| Percentage of VOCs | Inclacumab 30 mg/kg | Placebo |
|---|---|---|
| Rate of VOCs Leading to a Healthcare Visit That Requires Parenteral Pain Medication or an Increase in Treatment With Oral Narcotics Within 90 Days Following Randomization | 0.83 ± 0.57 | 0.76 ± 0.51 |
Collected over Day 1 through Day 161. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inclacumab 30 mg/kg | 1/36 (2.8%) | 4/36 (11.1%) | 20/36 (55.6%) |
| Placebo | 0/33 (0%) | 1/33 (3%) | 11/33 (33.3%) |
| Event | Inclacumab 30 mg/kg | Placebo |
|---|---|---|
| MalariaInfections and infestations | 1/36 | 1/33 |
| BradycardiaCardiac disorders | 1/36 | 0/33 |
| PneumoniaInfections and infestations | 1/36 | 0/33 |
| SepsisInfections and infestations | 1/36 | 0/33 |
| Acute kidney injuryRenal and urinary disorders | 1/36 | 0/33 |
| HaemothoraxRespiratory, thoracic and mediastinal disorders | 1/36 | 0/33 |
| Event | Inclacumab 30 mg/kg | Placebo |
|---|---|---|
| MalariaInfections and infestations | 5/36 | 3/33 |
| HeadacheNervous system disorders | 4/36 | 1/33 |
| Upper respiratory tract infectionInfections and infestations | 2/36 | 2/33 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/36 | 2/33 |
| Sickle cell anaemia with crisisBlood and lymphatic system disorders | 2/36 | 0/33 |
| HypertransaminasaemiaHepatobiliary disorders | 2/36 | 0/33 |
| Urinary tract infectionInfections and infestations | 2/36 | 0/33 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/36 | 1/33 |
| OsteonecrosisMusculoskeletal and connective tissue disorders | 2/36 | 0/33 |
| DizzinessNervous system disorders | 2/36 | 1/33 |
The intent-to-treat (ITT) population included all randomized participants.
| Age, Continuous(Years) | Inclacumab 30 mg/kg | Placebo | Total |
|---|---|---|---|
| Mean | 23.5 ± 6.95 | 24.9 ± 8.34 | 24.2 ± 7.64 |
| Sex: Female, Male(Participants) | Inclacumab 30 mg/kg | Placebo | Total |
|---|---|---|---|
| Female | 22 | 17 | 39 |
| Male | 15 | 18 | 33 |
| Ethnicity (NIH/OMB)(Participants) | Inclacumab 30 mg/kg | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 33 | 33 | 66 |
| Unknown or Not Reported | 1 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
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Studies of the drug tested here: Inclacumab