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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

A phase III, multi-center, 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

• 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.

• 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.

• 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.

Locations
United States
Washington, D.c.
Childrens National Hospital
RECRUITING
Washington D.c.
Florida
University of Florida
RECRUITING
Jacksonville
Georgia
Augusta University Georgia
RECRUITING
Augusta
WCG Sonar Clinical Research
RECRUITING
Riverdale
Kentucky
Norton Children s Hospital
RECRUITING
Louisville
North Carolina
East Carolina University
RECRUITING
Greenville
New York
Childrens Hospital at Montefiore
RECRUITING
The Bronx
Pennsylvania
Spoknwrdclinicaltrials
RECRUITING
Easton
Other Locations
Colombia
Novartis Investigative Site
RECRUITING
Medellín
Novartis Investigative Site
RECRUITING
Montería
Novartis Investigative Site
RECRUITING
Santiago De Cali
Novartis Investigative Site
RECRUITING
Santiago De Cali
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2030-04-19
Participants
Target number of participants: 315
Treatments
Experimental: Crizanlizumab (SEG101) at 5.0 mg/kg
Participants receive Crizanlizumab (SEG101) at 5.0 mg/kg and standard of care.
Placebo_comparator: Placebo
Participants receive the placebo drug and standard of care.
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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