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Trial record 73 of 113 for:    acyclovir

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

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ClinicalTrials.gov Identifier: NCT02977533
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE November 28, 2016
First Posted Date  ICMJE November 30, 2016
Last Update Posted Date May 24, 2018
Actual Study Start Date  ICMJE December 1, 2016
Actual Primary Completion Date May 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
Number of participants with treatment emergent adverse events [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02977533 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
  • Assessment of PK parameter: maximum concentration (Cmax) [ Time Frame: 4 weeks ]
  • Assessment of PK parameter: 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: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Progressive Multiple Sclerosis
Intervention  ICMJE
  • Drug: GZ402668

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Drug: Placebo

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Drug: Acyclovir

    Pharmaceutical form: tablet

    Route of administration: oral

Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: GZ402668
    • Drug: Acyclovir
  • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Acyclovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2018)
20
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2016)
24
Actual Study Completion Date  ICMJE May 16, 2018
Actual Primary Completion Date May 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02977533
Other Study ID Numbers  ICMJE TDU14981
2016-002415-18 ( EudraCT Number )
U1111-1184-8607 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP