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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 April 2016
• Main ID: NCT02282826
• Date of registration: 31/10/2014
• Prospective Registration: No
• Primary sponsor: Genzyme, a Sanofi Company
• Public title: A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02282826
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Progressive Multiple Sclerosis

Intervention(s)

Drug: placebo

Drug: acyclovir

Drug: GZ402668

Primary Outcome(s)

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

Secondary Outcome(s)

Number of participants with lymphocyte depletion [Time Frame: 4 weeks]

Number of participants with corrected QT interval (QTcF) prolongation [Time Frame: 4 weeks]

Number of participants with injection site reactions [Time Frame: 2 weeks]

Number of participants with anti-drug antibodies [Time Frame: 4 weeks]

maximum concentration (Cmax) [Time Frame: 4 weeks]

area under curve (AUC) [Time Frame: 4 weeks]

Secondary ID(s)

U1111-1155-6252

TDU13475

2014-001591-61

Source(s) of Monetary Support

Please refer to primary and secondary sponsors