Back to resultsA Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
Primary Purpose
Progressive Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
GZ402668
Placebo
Acyclovir
Sponsored by
About this trial
This is an interventional treatment trial for Progressive Multiple Sclerosis
Eligibility Criteria
Inclusion criteria :
- Male or female adult with a diagnosis of progressive multiple sclerosis (MS) including primary progressive MS, secondary progressive MS, or progressive relapsing MS.
- Aged between 18 and 65 years, inclusive.
- Body weight greater than 40.0 kg.
- Female patients of child bearing potential must use 2 highly effective contraception methods.
- Male patients, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, 2 highly effective contraception methods. Males patient, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after investigational medicinal product administration.
- Males patient who has agreed not to donate sperm for 4 months after product administration.
Exclusion criteria:
- Significant medical diseases or conditions, including poorly controlled hypertension, cardiovascular disease, inflammatory disorders, immunodeficiency, autoimmune disease, renal failure, liver dysfunction, cancer (except treated basal skin cell carcinoma), or active infection.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- History or presence of drug or alcohol abuse.
- Smoking more than 5 cigarettes or equivalent per day.
- If female, pregnancy, lactating, or breast-feeding.
- Patients with relapsing-remitting MS.
- Treatment with natalizumab, 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 past 4 weeks.
- Treatment with teriflunomide within the past 12 months unless patient has completed an accelerated clearance with cholestyramine.
- Previous treatment with alemtuzumab.
- Live, attenuated vaccine within 3 months prior to the randomization visit, such as varicella-zoster, oral polio, and rubella vaccines.
- Clinically significant abnormality in thyroid function.
- Inability to undergo magnetic resonance imaging with gadolinium administration.
- Hypersensitivity or contraindication to acyclovir.
- Known bleeding disorder.
- Significant autoimmune disease.
- Active infection or at high risk for infection.
- Latent or active tuberculosis.
- Major psychiatric disorder that is not adequately controlled by treatment.
- Epileptic seizures that are not adequately controlled by treatment.
- Prior history of invasive fungal infections.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 276001
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GZ402668
Placebo
Arm Description
Dose 1 (up to a maximum optional Dose 2) will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration.
A dose of matching placebo will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration.
Outcomes
Primary Outcome Measures
Number of participants with treatment emergent adverse events
Secondary Outcome Measures
Assessment of PK parameter: maximum concentration (Cmax)
Assessment of PK parameter: area under curve (AUC)
Number of participants with lymphocyte depletion
Number of participants with anti-drug antibodies
Number of participants with injection site reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02977533
Brief Title
A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
Official Title
A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of GZ402668 in Men and Women With Progressive Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
May 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective:
To assess the safety and tolerability of GZ402668 after a single subcutaneous (SC) dose in men and women with progressive multiple sclerosis.
Secondary Objectives:
To assess in men and women with progressive multiple sclerosis:
The pharmacokinetic (PK) parameters of GZ402668 after a single SC dose.
The pharmacodynamic (PD) response to GZ402668 after a single SC dose.
Detailed Description
The total study duration from screening for a patient can be approximately up to 8 weeks. Upon completion of this trial, patients treated with GZ402668 will be required to enroll in a 4 year safety follow-up study for continued safety observation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GZ402668
Arm Type
Experimental
Arm Description
Dose 1 (up to a maximum optional Dose 2) will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A dose of matching placebo will be given as a single subcutaneous administration under fed conditions. Acyclovir will be given twice daily starting on Day 1 and continuing for 28 days after investigational medicinal product administration.
Intervention Type
Drug
Intervention Name(s)
GZ402668
Intervention Description
Pharmaceutical form: solution
Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: solution
Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Acyclovir
Intervention Description
Pharmaceutical form: tablet
Route of administration: oral
Primary Outcome Measure Information:
Title
Number of participants with treatment emergent adverse events
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Assessment of PK parameter: maximum concentration (Cmax)
Time Frame
4 weeks
Title
Assessment of PK parameter: area under curve (AUC)
Time Frame
4 weeks
Title
Number of participants with lymphocyte depletion
Time Frame
4 weeks
Title
Number of participants with anti-drug antibodies
Time Frame
4 weeks
Title
Number of participants with injection site reactions
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Male or female adult with a diagnosis of progressive multiple sclerosis (MS) including primary progressive MS, secondary progressive MS, or progressive relapsing MS.
Aged between 18 and 65 years, inclusive.
Body weight greater than 40.0 kg.
Female patients of child bearing potential must use 2 highly effective contraception methods.
Male patients, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, 2 highly effective contraception methods. Males patient, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after investigational medicinal product administration.
Males patient who has agreed not to donate sperm for 4 months after product administration.
Exclusion criteria:
Significant medical diseases or conditions, including poorly controlled hypertension, cardiovascular disease, inflammatory disorders, immunodeficiency, autoimmune disease, renal failure, liver dysfunction, cancer (except treated basal skin cell carcinoma), or active infection.
Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
History or presence of drug or alcohol abuse.
Smoking more than 5 cigarettes or equivalent per day.
If female, pregnancy, lactating, or breast-feeding.
Patients with relapsing-remitting MS.
Treatment with natalizumab, 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 past 4 weeks.
Treatment with teriflunomide within the past 12 months unless patient has completed an accelerated clearance with cholestyramine.
Previous treatment with alemtuzumab.
Live, attenuated vaccine within 3 months prior to the randomization visit, such as varicella-zoster, oral polio, and rubella vaccines.
Clinically significant abnormality in thyroid function.
Inability to undergo magnetic resonance imaging with gadolinium administration.
Hypersensitivity or contraindication to acyclovir.
Known bleeding disorder.
Significant autoimmune disease.
Active infection or at high risk for infection.
Latent or active tuberculosis.
Major psychiatric disorder that is not adequately controlled by treatment.
Epileptic seizures that are not adequately controlled by treatment.
Prior history of invasive fungal infections.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 276001
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
We'll reach out to this number within 24 hrs