Progressive Multiple SclerosisPhase 1SCALANCT02583594
A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis
A Phase 1 study testing Acyclovir, Methylprednisolone and alemtuzumab GZ402673 in people with Progressive Multiple Sclerosis, run by Genzyme, a Sanofi Company at 1 site in Spain.
Trial summary
Primary Objective: To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab administered by subcutaneous injection and 2 treatment courses of alemtuzumab administered by intravenous infusion in patients with progressive multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Multiple Sclerosis
- What is being tested?
- Acyclovir, Methylprednisolone and alemtuzumab GZ402673
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 6 Dec 2015to 1 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 31Show fewer
- 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 β-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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Primary Objective:
- To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab administered by subcutaneous injection and 2 treatment courses of alemtuzumab administered by intravenous infusion in patients with progressive multiple sclerosis.
Secondary Objectives:
- To characterize the pharmacokinetic profiles of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis.
- To characterize the safety and tolerability of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis.
Read the detailed description
The duration of study per patient will be approximately 61 months.
- Conditions
- Progressive Multiple Sclerosis
- Being tested
- Acyclovir, Methylprednisolone, alemtuzumab GZ402673, Paracetamol, Loratadine
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
alemtuzumab GZ402673Drug
Pharmaceutical form:solution for infusion Route of administration: intravenous
alemtuzumab GZ402673Drug
Pharmaceutical form:injection Route of administration: subcutaneous
ParacetamolDrug
Pharmaceutical form:tablet Route of administration: oral
LoratadineDrug
Pharmaceutical form:tablet Route of administration: oral
CeterizineDrug
Pharmaceutical form:tablet Route of administration: oral
DexchlorpheniramineDrug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| alemtuzumab (subcutaneous injection) | Experimental | Dose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration. Receives: Drug: Acyclovir; Drug: Methylprednisolone; Drug: alemtuzumab GZ402673; Drug: Paracetamol; Drug: Loratadine; Drug: Ceterizine; Drug: Dexchlorpheniramine |
| alemtuzumab (intravenous infusion) | Experimental | Dose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration. Receives: Drug: Acyclovir; Drug: Methylprednisolone; Drug: alemtuzumab GZ402673; Drug: Paracetamol; Drug: Loratadine; Drug: Ceterizine; Drug: Dexchlorpheniramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the CD3+ lymphocyte subset after alemtuzumab administration
Measured: Baseline, 30 days after each treatment course
Secondary outcomes (11)
Change from baseline in lymphocyte subsets after alemtuzumab administration
Measured: Baseline, 30 days after each treatment course
Change from baseline in total lymphocyte count after alemtuzumab administration
Measured: Baseline, 30 days after each treatment course
Change from baseline in helper/suppressor ratio after alemtuzumab administration
Measured: Baseline, 30 days after each treatment course
Assessment of pharmacokinetic parameter after alemtuzumab administration: maximum plasma concentration observed (Cmax)
Measured: 30 days after each treatment course
Assessment of pharmacokinetic parameter after alemtuzumab administration: time to reach Cmax (Tmax)
Measured: 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)
Measured: 30 days after each treatment course
Assessment of pharmacokinetic parameter after alemtuzumab administration: area under plasma concentration (AUC)
Measured: 30 days after each treatment course
Assessment of pharmacokinetic parameter after alemtuzumab administration: terminal half-life (t1/2z)
Measured: 30 days after each treatment course
Number of patients with adverse events
Measured: 4 years
Number of patients with adverse events of special interest
Measured: 4 years
Number of patients with injection site reactions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start6 Dec 2015
- Primary completionMar 2016
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583594
- Sponsor's protocol ID
- TDU14260
- Other IDs
- 2015-002550-12, U1111-1171-7939, 2015
- Acronym
- SCALA
- Status last verified
- Mar 2021
- First submitted
- 16 Oct 2015
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Montalban X, Rodriguez-Acevedo B, Nos C, Resina M, Forner M, Wu Y, Chirieac M. SCALA: a randomized phase I trial comparing subcutaneous and intravenous alemtuzumab in patients with progressive multiple sclerosis. Ther Adv Neurol Disord. 2024 Nov 6;17:17562864241291655. doi: 10.1177/17562864241291655. eCollection 2024.
PubMed 39513023
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02583594
- Acronym / sponsor ID
- SCALA / TDU14260
- Conditions
- Progressive Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To characterize the pharmacodynamic profile of 2 treatment courses of alemtuzumab administered by subcutaneous injection and 2 treatment courses of alemtuzumab administered by intravenous infusion in patients with progressive multiple sclerosis.
Secondary Objectives:
- To characterize the pharmacokinetic profiles of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis.
- To characterize the safety and tolerability of alemtuzumab administered by subcutaneous injection or intravenous infusion to patients with progressive multiple sclerosis.
Detailed description
The duration of study per patient will be approximately 61 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alemtuzumab (subcutaneous injection) | Experimental | Drug: Acyclovir, Drug: Methylprednisolone, Drug: alemtuzumab GZ402673, Drug: Paracetamol, Drug: Loratadine, Drug: Ceterizine, Drug: DexchlorpheniramineDose 1 (initial course) of alemtuzumab will be administered subcutaneously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration. |
| alemtuzumab (intravenous infusion) | Experimental | Drug: Acyclovir, Drug: Methylprednisolone, Drug: alemtuzumab GZ402673, Drug: Paracetamol, Drug: Loratadine, Drug: Ceterizine, Drug: DexchlorpheniramineDose 1 (initial course) of alemtuzumab will be administered intravenously on 5 consecutive days, followed by Dose 2 (second course) on 3 consecutive days administered 12 months after initial course. Pre-medications (methylprednisolone, antihistamine [loratadine, cetirizine, dexchlorpheniramine], paracetamol, acyclovir) will be administered prior alemtuzumab administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcyclovirPharmaceutical form:tablet Route of administration: oral | Drug | alemtuzumab (intravenous infusion), alemtuzumab (subcutaneous injection) |
| MethylprednisolonePharmaceutical form:tablet Route of administration: oral | Drug | alemtuzumab (intravenous infusion), alemtuzumab (subcutaneous injection) |
| alemtuzumab GZ402673Pharmaceutical form:solution for infusion Route of administration: intravenous | Drug | alemtuzumab (intravenous infusion) |
| alemtuzumab GZ402673Pharmaceutical form:injection Route of administration: subcutaneous | Drug | alemtuzumab (subcutaneous injection) |
| ParacetamolPharmaceutical form:tablet Route of administration: oral | Drug | alemtuzumab (intravenous infusion), alemtuzumab (subcutaneous injection) |
| LoratadinePharmaceutical form:tablet Route of administration: oral | Drug | alemtuzumab (intravenous infusion), alemtuzumab (subcutaneous injection) |
| CeterizinePharmaceutical form:tablet Route of administration: oral | Drug | alemtuzumab (intravenous infusion), alemtuzumab (subcutaneous injection) |
| DexchlorpheniraminePharmaceutical form:tablet Route of administration: oral | Drug | alemtuzumab (intravenous infusion), alemtuzumab (subcutaneous injection) |
Primary outcome
Change from baseline in the CD3+ lymphocyte subset after alemtuzumab administration
Time frame: Baseline, 30 days after each treatment course
11 secondary outcomes
Change from baseline in lymphocyte subsets after alemtuzumab administration
Time frame: Baseline, 30 days after each treatment course
Change from baseline in total lymphocyte count after alemtuzumab administration
Time frame: Baseline, 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
Assessment of pharmacokinetic parameter after alemtuzumab administration: maximum plasma concentration observed (Cmax)
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
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: area under plasma concentration (AUC)
Time frame: 30 days after each treatment course
Assessment of pharmacokinetic parameter after alemtuzumab administration: terminal half-life (t1/2z)
Time frame: 30 days after each treatment course
Number of patients with adverse events
Time frame: 4 years
Number of patients with adverse events of special interest
Time frame: 4 years
Number of patients with injection site reactions
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 39513023Montalban X, Rodriguez-Acevedo B, Nos C, Resina M, Forner M, Wu Y, Chirieac M. SCALA: a randomized phase I trial comparing subcutaneous and intravenous alemtuzumab in patients with progressive multiple sclerosis. Ther Adv Neurol Disord. 2024 Nov 6;17:17562864241291655. doi: 10.1177/17562864241291655. eCollection 2024.
Related trials for Progressive Multiple Sclerosis
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acyclovir, Methylprednisolone and alemtuzumab GZ402673 in people with Progressive Multiple Sclerosis, run by Genzyme, a Sanofi Company at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the CD3+ lymphocyte subset after alemtuzumab administration (time frame: Baseline, 30 days after each treatment course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02583594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.