Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02282826
Other study ID # TDU13475
Secondary ID 2014-001591-61U1
Status Completed
Phase Phase 1
First received October 31, 2014
Last updated April 12, 2016
Start date October 2014
Est. completion date March 2016

Study information

Verified date April 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Germany: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
GZ402668
Pharmaceutical form:solution Route of administration: intravenous
placebo
Pharmaceutical form:solution Route of administration: intravenous
GZ402668
Pharmaceutical form:solution Route of administration: subcutaneous
placebo
Pharmaceutical form:solution Route of administration: subcutaneous
acyclovir
Pharmaceutical form:tablet Route of administration: oral

Locations

Country Name City State
Germany Investigational Site Number 276001 Berlin

Sponsors (1)

Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment emergent adverse events 4 weeks Yes
Secondary maximum concentration (Cmax) 4 weeks No
Secondary area under curve (AUC) 4 weeks No
Secondary Number of participants with lymphocyte depletion 4 weeks No
Secondary Number of participants with anti-drug antibodies 4 weeks Yes
Secondary Number of participants with injection site reactions 2 weeks Yes
Secondary Number of participants with corrected QT interval (QTcF) prolongation 4 weeks Yes
See also
  Status Clinical Trial Phase
Completed NCT02804594 - A Study of Oxidative Pathways in MS Fatigue Phase 2
Completed NCT04120675 - Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis N/A
Completed NCT01719159 - Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis Phase 2
Enrolling by invitation NCT03552211 - Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis
Recruiting NCT05740722 - Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis Phase 2
Completed NCT03980145 - G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis N/A
Completed NCT03269071 - Neural Stem Cell Transplantation in Multiple Sclerosis Patients Phase 1
Not yet recruiting NCT05811013 - Effects of Transcranial Static Magnetic Field Stimulation (tSMS) in Progressive Multiple Sclerosis N/A
Not yet recruiting NCT04289909 - Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS) N/A
Recruiting NCT05685784 - Multiple Sclerosis Prediction and Monitoring of Progression Study N/A
Completed NCT03493841 - Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis Phase 1
Completed NCT03302806 - Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
Recruiting NCT05441488 - Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis Phase 3
Recruiting NCT04695080 - ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis Phase 2/Phase 3
Recruiting NCT06451159 - A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis Phase 1
Completed NCT03423121 - A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis Phase 1/Phase 2
Terminated NCT02580669 - Study by Magnetic Resonance Imaging in the Progressive Forms of Multiple Sclerosis N/A
Enrolling by invitation NCT05706220 - Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
Recruiting NCT01815632 - Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS) Phase 2
Recruiting NCT01364246 - Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica Phase 1/Phase 2