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Sickle Cell Disease (STAND)

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

Overview

This Study Is Recruiting: Phase III Actual Start Date: [April 29, 2019] Estimated Completion Date: [September 7, 2027] Novartis Reference Number: CSEG101A2301
Condition: Sickle Cell Disease Interventions: Crizanlizumab, placebo Estimated Enrollment: [240 participants] ClinicalTrials.gov Identifier: NCT03814746
This Study Is Recruiting: Phase III Actual Start Date: [April 29, 2019]
Estimated Completion Date: [September 7, 2027] Novartis Reference Number: CSEG101A2301
Condition: Sickle Cell Disease Interventions: Crizanlizumab, placebo
Estimated Enrollment: [240 participants] ClinicalTrials.gov Identifier: NCT03814746

Study Goal

The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

Participants may be eligible to participate if they:

  • Are ≥ 12 years of age
  • Have a confirmed diagnosis of sickle cell disease
  • Experienced at least 2 vaso-occlusive crises leading to healthcare visit within the last 12 months prior to screening
  • Meet other eligibility

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.

Other sickle cell disease trials you might be interested in:

A Phase II, Multicenter, Open-Label Study to Assess Appropriate Dosing and to Evaluate Safety of Crizanlizumab, With or Without Hydroxyurea/Hydroxycarbamide, in Sequential, Descending Age Groups of Pediatric Sickle Cell Disease Patients With Vaso-Occlusive Crisis.

A Prospective Phase II, Open-Label, Single-arm, Multicenter, Study to Assess Efficacy and Safety of SEG101 (Crizanlizumab), in Sickle Cell Disease Patients With Priapism (SPARTAN)

Definitions:
ICF - informed consent form, SCD - sickle cell disease, VOC - vaso-occlusive crisis

Last Updated: July 31, 2019

7/19 M-GON-1216063