Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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22 March 2021 |
Main ID: |
NCT02583594 |
Date of registration:
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16/10/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis
SCALA |
Scientific title:
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A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis |
Date of first enrolment:
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December 6, 2015 |
Target sample size:
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24 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02583594 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Spain
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Contacts
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Name:
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Clinical Sciences & Operations |
Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Male or female adults with a diagnosis of Multiple Sclerosis (MS) based on 2010
revision of McDonald criteria.
- Diagnosis of progressive MS including primary progressive MS and secondary progressive
MS.
- Age =18 years.
- Signed informed consent form.
- Covered by a health insurance system where applicable, and/or in compliance with the
recommendations of the national laws in force relating to biomedical research.
- Not under any administrative or legal supervision.
Exclusion criteria:
- Patients with relapsing remitting MS.
- Any prior treatment with alemtuzumab or other anti-CD52 antibodies.
- Treatment with natalizumab in the 4 months prior to Study Visit 1.
- Progressive multifocal leukoencephalopathy (PML), or any clinical or imaging signs
possibly indicative of undiagnosed PML. Particular vigilance is needed for patients
with prior natalizumab exposure, even if the last exposure was more than 4 months
prior to Study Visit 1.
- Treatment with methotrexate, azathioprine, or cyclosporine in the past 6 months.
- Treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, or any other
immunosuppressant or cytotoxic therapy (other than steroids) in the last 12 months, or
determined by the treating physician to have residual immune suppression from these
treatments.
- Treatment with glatiramer acetate or interferon beta in the past 4 weeks.
- Treatment with fingolimod within the past 2 months.
- Treatment with dimethyl fumarate in the past 4 weeks.
- Treatment with teriflunomide within the past 12 months unless the patient has
completed an accelerated clearance with cholestyramine or activated charcoal.
- Any known contraindications to the symptomatic therapy used in the infusion management
guidance for this study.
- Hypersensitivity or contraindication to acyclovir.
- History of a hypersensitivity reaction other than localized injection site reaction to
any biological molecule.
- If female, pregnancy (defined as positive ß-HCG blood test) or lactating or
breast-feeding.
- Current participation in another investigational interventional study.
- Any significant change in chronic treatment medication (ie, new chronic medication)
within 14 days before inclusion.
- An investigational medicinal product within 3 months or 5 half-lives, whichever is
longer, before study inclusion.
- Total lymphocyte or CD3+ counts are below normal limits at screening. If abnormal cell
count(s) return to within normal limits, eligibility may be reassessed.
- Live, attenuated vaccine within 3 months prior to the randomization (Day 1) visit,
such as varicella-zoster, oral polio, rubella vaccines.
- Any clinically relevant findings in the physical examination, medical history, or
laboratory assessments which would compromise the safety of the patient.
- Women of childbearing potential not protected by highly-effective method(s) of birth
control and/or who are unwilling or unable to be tested for pregnancy.
- Latent or active tuberculosis infection, verified by testing as per local practice.
- Infection with human immunodeficiency virus (HIV).
- Known Hepatitis B (HBV) or Hepatitis C (HCV) infection.
- Active infection, eg, deep tissue infection, that the Investigator considers
sufficiently serious to preclude study participation.
- Prior history of invasive fungal infections.
- Any patient who, in the judgment of the Investigator, is likely to be noncompliant
during the study, or unable to cooperate because of a language problem or poor mental
development.
- Any patient in the exclusion period of a previous study according to applicable
regulations.
- Any patient who cannot be contacted in case of emergency.
- Any patient who is the Investigator or any subinvestigator, research assistant,
pharmacist, study coordinator, other staff or relative thereof directly involved in
the conduct of the protocol.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Progressive Multiple Sclerosis
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Intervention(s)
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Drug: Dexchlorpheniramine
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Drug: Ceterizine
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Drug: Loratadine
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Drug: Acyclovir
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Drug: Paracetamol
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Drug: Methylprednisolone
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Drug: alemtuzumab GZ402673
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Primary Outcome(s)
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Change from baseline in the CD3+ lymphocyte subset after alemtuzumab administration
[Time Frame: Baseline, 30 days after each treatment course]
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Secondary Outcome(s)
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Change from baseline in lymphocyte subsets after alemtuzumab administration
[Time Frame: Baseline, 30 days after each treatment course]
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Assessment of pharmacokinetic parameter after alemtuzumab administration: area under plasma concentration versus time curve from time zero until the last measurable concentration (AUClast)
[Time Frame: 30 days after each treatment course]
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Assessment of pharmacokinetic parameter after alemtuzumab administration: maximum plasma concentration observed (Cmax)
[Time Frame: 30 days after each treatment course]
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Number of patients with injection site reactions
[Time Frame: 2 years]
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Change from baseline in total lymphocyte count after alemtuzumab administration
[Time Frame: Baseline, 30 days after each treatment course]
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Number of patients with adverse events of special interest
[Time Frame: 4 years]
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Assessment of pharmacokinetic parameter after alemtuzumab administration: terminal half-life (t1/2z)
[Time Frame: 30 days after each treatment course]
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Assessment of pharmacokinetic parameter after alemtuzumab administration: area under plasma concentration (AUC)
[Time Frame: 30 days after each treatment course]
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Assessment of pharmacokinetic parameter after alemtuzumab administration: time to reach Cmax (Tmax)
[Time Frame: 30 days after each treatment course]
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Change from baseline in helper/suppressor ratio after alemtuzumab administration
[Time Frame: Baseline, 30 days after each treatment course]
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Number of patients with adverse events
[Time Frame: 4 years]
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Secondary ID(s)
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U1111-1171-7939
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2015-002550-12
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TDU14260
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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