Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia



Status:Recruiting
Conditions:Anemia, Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:8 - 20
Updated:2/17/2019
Start Date:April 5, 2017
End Date:August 7, 2020
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.co
Phone:1-888-669-6682

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A Multiple-dose, Subject- and Investigator-blinded, Placebo-controlled, Parallel Design Study to Assess the Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia

To determine the effect of canakinumab versus placebo on daily pain experienced by sickle
cell anemia patients (Reduction of average daily pain VAS over the period of Week 8 to 12 as
compared to baseline levels).


Inclusion Criteria:

- Male and female subjects ages 8-20 years of age (both inclusive) diagnosed with sickle
cell anemia (HbSS) or sickle beta0 thalassemia (documented by family studies, or
analysis of either hemoglobin or DNA).

- Patient's written informed consent from those ≥18 years of age must be obtained before
any assessment is performed. Parent or legal guardian's written informed consent and
child's assent, if appropriate, are required before any assessment is performed for
patients < 18 years of age.

- Detectable baseline of background or episodic pain measured by daily e-diary over 1 to
2 weeks during screening period as defined below: Average daily pain score ≥ 1 cm
without analgesic use over a period of at least 7 days and/or, At least one episode of
pain requiring analgesic use during a period of up to 14 days.

- History of ≥2 vaso-occlusive pain episodes in the past year, as defined as pain with
no other, non-sickle cell identifiable cause that requires analgesia and interferes
with the patient's normal daily routine.

Exclusion Criteria:

- History of known hypersensitivity to canakinumab.

- Ongoing or treatment with the past 3 months with red blood cell transfusion therapy,
or have evidence of iron overload requiring chelation therapy.

- Transcranial Doppler ultrasound in the past year or at screening in patients with an
accessible transtemporal window, demonstrating velocity in middle or anterior cerebral
or internal carotid artery ≥200 cm/sec.

- Administration of any other blood products within 3 weeks of screening visit.

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
7
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Toronto, Ontario
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Atlanta, Georgia 30322
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Augusta, Georgia 30904
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Greenville, North Carolina 27834
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Miami, Florida 33136
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Philadelphia, Pennsylvania 19102
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