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

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Medical Conditions
  • Sickle Cell Anemia
Primary Contact Details
Novartis Pharmaceuticals
1-888-669-6682
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02961218
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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).
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Ilaris, Canakinumab, Drug : Placebo

Study Arm Groups : Ilaris, Canakinumab, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Reduction of average daily pain; Week 8 to 12
Secondary Outcome Measures
    Reduction of average daily pain over 24 weeks; Baseline, 24 weeks; The effect of canakinumab versus placebo on sickle cell anemia related days missed from school or work; 56 weeks; Measurement of pharmacokinetics of canakinumab in sickle cell anemia patients, which will be presented as descriptive summary statistics of pharmacokinetic concentrations.; 48 weeks; Week 12 versus baseline of white blood cell count; Baseline, 12 weeks; Week 12 versus baseline of absolute counts of blood neutrophils; Baseline, 12 weeks; Week 12 versus baseline of absolute counts of blood monocytes; Baseline, 12 weeks; Week 12 versus baseline of serum hs-CRP; Baseline, 12 weeks; Week 12 versus baseline of Hemoglobin concentration; Baseline, 12 weeks; Week 12 versus baseline of reticulocyte count; Baseline, 12 weeks; Week 12 versus baseline of Haptoglobin; Baseline, 12 weeks; Week 12 versus baseline of LDH; Baseline, 12 weeks; Week 12 versus baseline of total bilirubin; Baseline, 12 weeks; Week 12 versus baseline of oxygen percent saturation (SAO2); Baseline, 12 weeks
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
8 Years - 20 Years
Who Can Participate
Patients
Number of Participants
60
Participant Inclusion Criteria
    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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
SE1 7EH
London
SE5 9RS
London
E1 1BB
London
NW1 2BU
Staffordshire
WS11 5XY
Trial Contact(s)
Primary Trial Contact
Novartis Pharmaceuticals
1-888-669-6682
Other Trial Contacts
Novartis Pharmaceuticals
+41613241111
Countries Recruiting
Canada, Germany, Israel, South Africa, Turkey, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CACZ885X2206
Sponsor(s)
Novartis Pharmaceuticals
Key Dates

Recruitment Start Date

Apr 2017

Recruitment End Date

Aug 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

20 Oct 2016

Date updated in source

12 Feb 2019