World Health Organization site
Skip Navigation Links

Main
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: ClinicalTrials.gov
Last refreshed on: 22 March 2021
Main ID:  NCT02583594
Date of registration: 16/10/2015
Prospective Registration: Yes
Primary sponsor: Genzyme, a Sanofi Company
Public title: A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis SCALA
Scientific title: 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: December 6, 2015
Target sample size: 24
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02583594
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Spain
Contacts
Name:     Clinical Sciences & Operations
Address: 
Telephone:
Email:
Affiliation:  Sanofi
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Progressive Multiple Sclerosis
Intervention(s)
Drug: Dexchlorpheniramine
Drug: Ceterizine
Drug: Loratadine
Drug: Acyclovir
Drug: Paracetamol
Drug: Methylprednisolone
Drug: alemtuzumab GZ402673
Primary Outcome(s)
Change from baseline in the CD3+ lymphocyte subset after alemtuzumab administration [Time Frame: Baseline, 30 days after each treatment course]
Secondary Outcome(s)
Change from baseline in lymphocyte subsets after alemtuzumab administration [Time Frame: Baseline, 30 days after each treatment course]
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]
Assessment of pharmacokinetic parameter after alemtuzumab administration: maximum plasma concentration observed (Cmax) [Time Frame: 30 days after each treatment course]
Number of patients with injection site reactions [Time Frame: 2 years]
Change from baseline in total lymphocyte count after alemtuzumab administration [Time Frame: Baseline, 30 days after each treatment course]
Number of patients with adverse events of special interest [Time Frame: 4 years]
Assessment of pharmacokinetic parameter after alemtuzumab administration: terminal half-life (t1/2z) [Time Frame: 30 days after each treatment course]
Assessment of pharmacokinetic parameter after alemtuzumab administration: area under plasma concentration (AUC) [Time Frame: 30 days after each treatment course]
Assessment of pharmacokinetic parameter after alemtuzumab administration: time to reach Cmax (Tmax) [Time Frame: 30 days after each treatment course]
Change from baseline in helper/suppressor ratio after alemtuzumab administration [Time Frame: Baseline, 30 days after each treatment course]
Number of patients with adverse events [Time Frame: 4 years]
Secondary ID(s)
U1111-1171-7939
2015-002550-12
TDU14260
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history