Home › Trials › NCT06439082

Investigating Crizanlizumab for Sickle Cell Disease in Adolescents and Adults

A Phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) Versus Placebo, With or Without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Frequent Vaso-Occlusive Crises

Phase 3 Interventional Novartis · NCT06439082

This study is testing if a new medication called crizanlizumab can help reduce painful episodes in adolescents and adults with sickle cell disease.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment315 (estimated)
Ages12 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionscrizanlizumab
Locations31 sites (Birmingham, Alabama and 30 other locations)
Trial IDNCT06439082 on ClinicalTrials.gov

What this trial studies

This phase III, multicenter, randomized, double-blind study evaluates the efficacy and safety of crizanlizumab (5 mg/kg) compared to a placebo in adolescents and adults with sickle cell disease who experience frequent vaso-occlusive crises. Participants aged 12 years and older will be randomly assigned to receive either crizanlizumab or placebo, with stratification based on concurrent hydroxyurea/hydroxycarbamide therapy and geographic region. The study aims to determine if crizanlizumab can reduce the frequency of vaso-occlusive crises in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adolescents and adults aged 12 years and older with a confirmed diagnosis of sickle cell disease who have experienced 4 to 12 vaso-occlusive crises in the past year.

Not a fit: Patients who do not experience frequent vaso-occlusive crises or those with other severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of painful vaso-occlusive crises in patients with sickle cell disease.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific investigation into crizanlizumab is novel in its focus on frequent vaso-occlusive crises.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to \<18 years old and adults include participants aged 18 years and older.
2. Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible.
3. Experienced 4 to 12 VOCs (refer to Section 8.3.1 for study definition of VOC) that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source.
4. If the participant is on HU/HC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU/HC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU/HC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment.

Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit.

Key Exclusion Criteria:

1. Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source.
2. History of stem cell transplant and/or gene therapy.
3. Received blood products within 30 days prior to Week 1 Day 1 dosing.
4. Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded.
5. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted.
6. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.

Where this trial is running

Birmingham, Alabama and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sickle Cell DiseaseSCDSEG101CrizanlizumabHydroxyurea/ Hydroxycarbamide TherapyVaso-Occlusive CrisesSickle Cell Anemiablood disorders
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.