Trial · NCT04935879

A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

NCT04935879, Phase 3, Completed, Pfizer; results first posted 2025-12-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises. Trials, record NCT04935879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04935879

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
NCT number: NCT04935879
Status: Completed
Phases: Phase 3
Enrollment: 241 participants, actual
Lead sponsor: Pfizer
Conditions: Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Vaso-occlusive Crisis
Interventions: Inclacumab, Placebo
First posted: 2021-06-23
Last updated: 2025-12-02
Other registries' IDs: eudract:2020-005286-13
Results first posted: 2025-12-02

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48	Randomization (Day 1) up to Week 48	A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. The rate of VOC was defined as number of VOC events per 48 weeks and presented in this outcome measure.
Secondary	Time to First VOC Through Week 48	Randomization (Day 1) up to Week 48	A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to first VOC was the time between randomization date and onset date of first VOC event during 48 weeks. Kaplan-Meier method was used for estimation.
Secondary	Time to Second VOC Through Week 48	Randomization (Day 1) up to Week 48	A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to second VOC was the time between randomization date and onset date of second VOC event during 48 weeks. Kaplan-Meier method was used for estimation.
Secondary	Percentage of Participants With no VOCs Through Week 48	Randomization (Day 1) up to Week 48	A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Participants without an observed VOC who discontinued the study prior to the end of the 48-week treatment period were assumed to had experienced at least one VOC.
Secondary	Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48	Randomization (Day 1) up to Week 48	A VOC that required admission to a healthcare facility and treatment with parenteral pain medication where admission 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. The rate of VOC was defined as number of VOC events per 48 weeks; rate of VOCs which required admission to a healthcare facility and treatment with parenteral pain medication is presented in this outcome measure.
Secondary	Rate of Inpatient Hospitalization Days for a VOC Through Week 48	Randomization (Day 1) up to Week 48	A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility hospitalization. For each VOC event requiring inpatient hospitalization (regardless of treatment received) during the 48-week, the number of days hospitalized were determined based on the hospital admission and discharge dates. The rate of inpatient hospitalization days was defined as number of inpatient hospitalization days for a VOC per 48 weeks and presented in this outcome measure.
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Day 1 up to Week 60 (12 week of follow-up post Week 48)	An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE was defined as an AE with an onset after the initiation of dosing for the first dose of study drug. A serious adverse events (SAE) or serious suspected adverse reaction is an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization and congenital anomaly/birth defect. AEs included both serious and all non-SAEs.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48	Randomization (Day 1) up to Week 48	The ITT population included all randomized participants.	Events per 48 weeks	NUMBER
SECONDARY	Time to First VOC Through Week 48	Randomization (Day 1) up to Week 48	The ITT population included all randomized participants.	Weeks	MEDIAN
SECONDARY	Time to Second VOC Through Week 48	Randomization (Day 1) up to Week 48	The ITT population included all randomized participants.	Weeks	MEDIAN
SECONDARY	Percentage of Participants With no VOCs Through Week 48	Randomization (Day 1) up to Week 48	The ITT population included all randomized participants.	Percentage of participants	NUMBER
SECONDARY	Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48	Randomization (Day 1) up to Week 48	The ITT population included all randomized participants.	Events per 48 weeks	NUMBER
SECONDARY	Rate of Inpatient Hospitalization Days for a VOC Through Week 48	Randomization (Day 1) up to Week 48	The ITT population included all randomized participants.	Hospitalization days per 48 weeks	NUMBER
SECONDARY	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Day 1 up to Week 60 (12 week of follow-up post Week 48)	Safety population included randomized participants who received treatment with study drug.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48	Inclacumab	1.49	95% Confidence Interval 1.22 to 1.83	Events per 48 weeks
Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48	Placebo	1.58	95% Confidence Interval 1.30 to 1.93	Events per 48 weeks
Time to First VOC Through Week 48	Inclacumab	28.7	95% Confidence Interval 15.7 to 43.1	Weeks
Time to First VOC Through Week 48	Placebo	21.6	95% Confidence Interval 17.3 to 28.7	Weeks
Time to Second VOC Through Week 48	Inclacumab	NA	95% Confidence Interval NA to NA	Weeks
Time to Second VOC Through Week 48	Placebo	NA	95% Confidence Interval NA to NA	Weeks
Percentage of Participants With no VOCs Through Week 48	Inclacumab	36.0	95% Confidence Interval 27.1 to 45.0	Percentage of participants
Percentage of Participants With no VOCs Through Week 48	Placebo	25.7	95% Confidence Interval 17.7 to 33.7	Percentage of participants
Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48	Inclacumab	0.85	95% Confidence Interval 0.65 to 1.10	Events per 48 weeks
Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48	Placebo	0.83	95% Confidence Interval 0.64 to 1.08	Events per 48 weeks

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Inclacumab	119
Overall Study	STARTED	Placebo	122
Overall Study	Treated	Inclacumab	118
Overall Study	Treated	Placebo	121
Overall Study	COMPLETED	Inclacumab	103
Overall Study	COMPLETED	Placebo	108
Overall Study	NOT COMPLETED	Inclacumab	16
Overall Study	NOT COMPLETED	Placebo	14

Source ClinicalTrials.gov

Adverse events542

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Sickle cell anaemia with crisis	Blood and lymphatic system disorders	Inclacumab	21	118
other	Sickle cell anaemia with crisis	Blood and lymphatic system disorders	Placebo	21	121
other	Anaemia	Blood and lymphatic system disorders	Inclacumab	5	118
other	Anaemia	Blood and lymphatic system disorders	Placebo	9	121
other	Thrombocytopenia	Blood and lymphatic system disorders	Inclacumab	4	118
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	0	121
other	Neutropenia	Blood and lymphatic system disorders	Inclacumab	3	118
other	Neutropenia	Blood and lymphatic system disorders	Placebo	0	121
other	Haemolysis	Blood and lymphatic system disorders	Inclacumab	1	118
other	Haemolysis	Blood and lymphatic system disorders	Placebo	0	121

1 to 10 of 542Source ClinicalTrials.gov

See all 542 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Inclacumab	3	118
Total, all-cause mortality	Placebo	2	121
Total, other adverse events	Inclacumab	83	118
Total, other adverse events	Placebo	90	121
Total, serious adverse events	Inclacumab	23	118
Total, serious adverse events	Placebo	27	121

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Inclacumab vs Placebo: Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Trial comparisons
Inclacumab vs Placebo: deaths from any cause	Trial comparisons
Inclacumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04935879

GET https://conductscience.org/api/trials/v1/NCT04935879/events?page=2

API reference For AI assistants