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Trial details
Trial details
Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients ( STAND)
Current status:
Approved
|
Date registered:
09/12/2022
Trial version(s)
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
History: 11/06/2019
Current: 11/06/2019
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Main Information
Primary registry identifying number
LBCTR2019060244
Protocol number
CSEG101A2301
MOH registration number
24334/2019
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients ( STAND)
Acronym
Scientific title
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)
Acronym
Brief summary of the study: English
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.
Brief summary of the study: Arabic
دراسة مرحلة ثالثة، متعددة المراكز، عشوائيّة التوزيع ومزدوجة التعمية لتقييم فعاليّة وسلامة جرعتين من دواء كريزانليزوماب مقابل الدواء الوهمي، مع أو بدون علاج هيدروكسي يوريا / هيدروكسي كاربامايد، لدى المرضى المراهقين والبالغين المصابين بداء الكريات المنجليّة مع نوبات انسداد وعائيّ (STAND)
Health conditions/problem studied: Specify
Sickle Cell Disease
Interventions: Specify
•Drug: Crizanlizumab (SEG101) Crizanlizumab will be supplied in single use 10 mL glass vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab. This is a concentrate for solution for infusion IV. Other Name: SEG101 •Drug: Placebo Placebo will be supplied in single use 10 mL glass vials at a concentration of 10 mg/mL. One vial contains 100 mg of placebo. This is a concentrate for solution for infusion IV.
Key inclusion and exclusion criteria: Inclusion criteria
1.Written informed consent must be obtained prior to any screening procedures 2.Male or female patients aged 12 years and older on the day of signing informed consent. Adolescent include patients aged 12 to 17 years old and adults ≥ 18 years and older 3.Confirmed diagnosis of SCD by hemoglobin electrophoresis or high performance liquid chromatography (HPLC) [performed locally]. All SCD genotypes are eligible, genotyping is not required for study entry 4.Experienced at least 2 VOCs leading to healthcare visit within the 12 months prior to screening visit as determined by medical history. Prior VOC leading to healthcare visit must include: a.Pain crisis defined as an acute onset of pain for which there is no other medically determined explanation other than vaso- occlusion - b.a visit to a medical facility and/or healthcare professional, c.and receipt of oral/parenteral opioids or parenteral nonsteroidal anti-inflammatory drug (NSAID) analgesia As well as other complicated crises, such as acute chest syndrome, priapism, and hepatic or splenic sequestration 5.If receiving HU/HC or erythropoietin stimulating agent or L-glutamine, must have been receiving the drug for at least 6 months prior to Screening visit and plan to continue taking at the same dose and schedule until the subject has reached one year of study treatment 6.Patients must meet the following central laboratory values at the screening visit: ◦Absolute Neutrophil Count ≥1.0 x 109/L ◦Platelet count ≥75 x 109/L ◦Hemoglobin: for adults (Hb) ≥4.0 g/dL and for adolescents (Hb) ≥5.5 g/dL ◦Glomerular filtration rate ≥ 45 mL/min/1.73 m2 using CKD-EPI formula in adults, and Shwartz formula in adolescents ◦Direct (conjugated) bilirubin < 2.0 x ULN ◦Alanine transaminase (ALT) < 3.0 x ULN 7.ECOG performance status ≤2.0 for adults and Karnofsky ≥ 50% for adolescents
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
12
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
1.History of stem cell transplant. 2.Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning on undergoing an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted. 3.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. 4.Received active treatment on another investigational trial within 30 days (or 5 half-lives of that agent, whichever is greater) prior to Screening visit or plans to participate in another investigational drug trial. 5.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they are using highly effective methods of contraception during dosing and for 15 weeks after stopping treatment. 6.Concurrent severe and/or uncontrolled medical conditions which, in the opinion of the Investigator, could cause unacceptable safety risks or compromise participation in the study. 7.History or current diagnosis of ECG abnormalities indicating significant risk of safety such as: ◦Resting QTcF ≥470 msec at pretreatment (baseline) for both male and female or inestability to determine QTc ◦Concomitant clinically significant cardiac arrhythmias (e.g ventricular tachycardia), and clinically significant second or third degree AV block without a pacemaker ◦History of familial long QT syndrome or know family history of Torsades de Pointes 8.Not able to understand and to comply with study intructions and requirements.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Prevention
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
SEG101 - Crizanlizumab
Type of IMP
Immunological
Pharmaceutical class
anti-human P-selectin antibody G1
Therapeutic indication
prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD)
Therapeutic benefit
To compare the efficacy of 5.0 mg/kg versus placebo and 7.5 mg/kg of crizanlizumab versus placebo in addition to standard of care. To compare the efficacy of 7.5 mg/kg versus placebo on the annualized rate of all VOCs (managed at home + leading to healthcare visit), based on documentation by health care provider following contact with participant. To compare the efficacy of 5.0 mg/kg versus placebo on the annualized rate of all VOCs (managed at home + leading to healthcare visit)
Biospecimen retention
Samples without DNA
Biospecimen description
All Blood samples and Urine Samples will be shipped to Covance Geneva Central Lab
Target sample size
17
Actual enrollment target size
11
Date of first enrollment: Type
Actual
Date of first enrollment: Date
07/08/2019
Date of study closure: Type
Actual
Date of study closure: Date
29/07/2027
Recruitment status
Complete
Date of completion
24/06/2021
IPD sharing statement plan
No
IPD sharing statement description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT03814746?term=cseg101a2301&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinicaltrials.gov
NCT03814746
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Adlette
Inati
Tripoli
Lebanon
03228033
adlette.inati@lau.edu.lb
Nini Hospital
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Miguel
Abboud
Beirut
Lebanon
03534213
ma56@aub.edu.lb
American University of Beirut Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Nini Hospital
Adlette Inati
Hematology
Approved
AUBMC
Miguel Abboud
Hematology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Nini Hospital
20/05/2019
Nabil Kabbara
Nabil.kabbara@hopitalnini.com
+961 (0) 6 431 400 ext 1062
American University of Beirut Medical Center
30/12/2019
Fuad Ziyadeh
fz05@aub.edu.lb
+961 (0) 1 350 000 ext:5445
Countries of Recruitment
Name
Lebanon
Belgium
Netherlands
United Kingdom
United States of America
Jordan
Health Conditions or Problems Studied
Condition
Code
Keyword
Sickle Cell Disease
Sickle-cell disorders (D57)
SCD
Interventions
Intervention
Description
Keyword
ICF, Lab tests, IMP , Questionnaires
ICF, Lab tests, IMP , Questionnaires
ICF, Lab tests, IMP , Questionnaires
Primary Outcomes
Name
Time points
Measure
Rate of vaso-occlusive crisis (VOC) events leading to
1 year
1 year
To compare the efficacy of 5.0 mg/kg versus placebo and 7.5 mg/kg of crizanlizumab versus placebo in addition to standard of care
1 year
1 year
Key Secondary Outcomes
Name
Time points
Measure
•Rate of all VOCs leading to healthcare visit and treated at home
1 year, 5 years
1 year, 5 years
•Number of days with VOC leading to healthcare visit
1 year
1 year
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Annual Review
02/12/2022
SEG101 SUSARS 01APR2022 30SEP2022
02/12/2022
SEG101 IB Edittion 12
02/12/2022
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