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A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02282826
First Posted: November 4, 2014
Last Update Posted: April 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  Purpose

Primary Objective:

To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV) and subcutaneous (SC) doses in men and women with progressive multiple sclerosis.

Secondary Objectives:

To assess the following in men and women with progressive multiple sclerosis:

  • The pharmacokinetic (PK) parameters of GZ402668 after ascending single IV doses.
  • The pharmacodynamics (PD) of GZ402668 after ascending single IV doses.
  • The PK parameters of GZ402668 after ascending single SC doses.
  • The PD of GZ402668 after ascending single SC doses.

Condition Intervention Phase
Progressive Multiple Sclerosis Drug: GZ402668 Drug: placebo Drug: acyclovir Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Intravenous and Subcutaneous Doses of GZ402668 in Men and Women With Progressive Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • Number of participants with treatment emergent adverse events [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • maximum concentration (Cmax) [ Time Frame: 4 weeks ]
  • area under curve (AUC) [ Time Frame: 4 weeks ]
  • Number of participants with lymphocyte depletion [ Time Frame: 4 weeks ]
  • Number of participants with anti-drug antibodies [ Time Frame: 4 weeks ]
  • Number of participants with injection site reactions [ Time Frame: 2 weeks ]
  • Number of participants with corrected QT interval (QTcF) prolongation [ Time Frame: 4 weeks ]

Enrollment: 48
Study Start Date: October 2014
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 IV
GZ402668 dose 1 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Drug: GZ402668
Pharmaceutical form:solution Route of administration: intravenous
Drug: acyclovir
Pharmaceutical form:tablet Route of administration: oral
Experimental: Dose 2 IV
GZ402668 dose 2 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Drug: GZ402668
Pharmaceutical form:solution Route of administration: intravenous
Drug: acyclovir
Pharmaceutical form:tablet Route of administration: oral
Experimental: Dose 3 IV
GZ402668 dose 3 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Drug: GZ402668
Pharmaceutical form:solution Route of administration: intravenous
Drug: acyclovir
Pharmaceutical form:tablet Route of administration: oral
Experimental: Dose 3 SC
GZ402668 dose 3 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Drug: GZ402668
Pharmaceutical form:solution Route of administration: subcutaneous
Drug: acyclovir
Pharmaceutical form:tablet Route of administration: oral
Experimental: Dose 4 SC
GZ402668 dose 4 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Drug: GZ402668
Pharmaceutical form:solution Route of administration: subcutaneous
Drug: acyclovir
Pharmaceutical form:tablet Route of administration: oral
Experimental: Dose 5 SC
GZ402668 dose 5 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Drug: GZ402668
Pharmaceutical form:solution Route of administration: subcutaneous
Drug: acyclovir
Pharmaceutical form:tablet Route of administration: oral
Placebo Comparator: Placebo SC
placebo subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Drug: placebo
Pharmaceutical form:solution Route of administration: subcutaneous
Drug: acyclovir
Pharmaceutical form:tablet Route of administration: oral
Placebo Comparator: Placebo IV
placebo intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy
Drug: placebo
Pharmaceutical form:solution Route of administration: intravenous
Drug: acyclovir
Pharmaceutical form:tablet Route of administration: oral

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female adult with a diagnosis of progressive multiple sclerosis (MS) including primary progressive MS, secondary progressive MS, and progressive relapsing MS.
  • Aged between 18 and 65 years, inclusive.
  • Body weight greater than 40.0 kg.
  • Female patient of child bearing potential must use 2 highly effective contraception methods.
  • Male patient, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, 2 highly effective contraception methods. Male patient, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after investigational medicinal product administration.
  • Male 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.
  • Lymphocyte counts below the lower limit of normal.
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282826


Locations
Germany
Investigational Site Number 276001
Berlin, Germany, 10117
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02282826     History of Changes
Other Study ID Numbers: TDU13475
2014-001591-61 ( EudraCT Number )
U1111-1155-6252 ( Other Identifier: UTN )
First Submitted: October 31, 2014
First Posted: November 4, 2014
Last Update Posted: April 13, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents