A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT02977533

Collaborator

(none)

Enrollment

Location

Arms

17.4

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Progressive Multiple Sclerosis	Drug: GZ402668 Drug: Placebo Drug: Acyclovir	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

May 16, 2018

Actual Study Completion Date :

May 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GZ402668 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.	Drug: GZ402668 Pharmaceutical form: solution Route of administration: subcutaneous Drug: Acyclovir Pharmaceutical form: tablet Route of administration: oral
Placebo Comparator: Placebo 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.	Drug: Placebo Pharmaceutical form: solution Route of administration: subcutaneous Drug: Acyclovir Pharmaceutical form: tablet Route of administration: oral

Arm

Intervention/Treatment

Experimental: GZ402668

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.

Drug: GZ402668

Pharmaceutical form: solution Route of administration: subcutaneous

Drug: Acyclovir

Pharmaceutical form: tablet Route of administration: oral

Placebo Comparator: Placebo

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.

Drug: Placebo

Pharmaceutical form: solution Route of administration: subcutaneous

Drug: Acyclovir

Pharmaceutical form: tablet Route of administration: oral

Outcome Measures

Primary Outcome Measures

Number of participants with treatment emergent adverse events [4 weeks]

Secondary Outcome Measures

Assessment of PK parameter: maximum concentration (Cmax) [4 weeks]
Assessment of PK parameter: area under curve (AUC) [4 weeks]
Number of participants with lymphocyte depletion [4 weeks]
Number of participants with anti-drug antibodies [4 weeks]
Number of participants with injection site reactions [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 276001	Berlin		Germany	10117

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT02977533

Other Study ID Numbers:

TDU14981
2016-002415-18
U1111-1184-8607

First Posted:

Nov 30, 2016

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Multiple Sclerosis

Multiple Sclerosis, Chronic Progressive

Sclerosis

Acyclovir

Study Results

No Results Posted as of Apr 25, 2022