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

NCT02977533 | Completed Phase 1

• 3 other identifiers: TDU149812016-002415-18U1111-1184-8607
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment emergent adverse events

  4 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

GZ402668

EXPERIMENTAL

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; Drug: Acyclovir

Placebo

PLACEBO COMPARATOR

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; Drug: Acyclovir

Interventions

GZ402668 DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

GZ402668

Placebo DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Placebo

Acyclovir DRUG

Pharmaceutical form: tablet Route of administration: oral

GZ402668; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males patient who has agreed not to donate sperm for 4 months after product administration.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 276001

Berlin, 10117, Germany

Location

Related Publications (1)

• Albach FN, Geier C, Keicher C, Posch MG, Schreiber SJ, Grutz G, Akyuz L, Luo X, Le-Halpere A, Truffinet P, Wagner F. Phase 1 Trials of Gatralimab, a Next-Generation Humanized Anti-CD52 Monoclonal Antibody, in Participants with Progressive Multiple Sclerosis. Neurol Ther. 2024 Dec;13(6):1607-1625. doi: 10.1007/s40120-024-00659-w. Epub 2024 Sep 9.

  PMID: 39251561 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: November 30, 2016
• Study Start: December 1, 2016
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)