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

Phase 1

Completed

• Conditions: Progressive Multiple Sclerosis
• Interventions: Drug: GZ402668; Drug: Placebo; Drug: Acyclovir

• Registration Number: NCT02977533
• Lead Sponsor: Sanofi

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 Timeline

• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-30
• Study Start: 2016-12-01
• Primary Completion: 2018-05-16
• Study Completion: 2018-05-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GZ402668	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.
GZ402668	Acyclovir	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.
Placebo	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.
Placebo	Acyclovir	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events	4 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameter: maximum concentration (Cmax)	4 weeks
Assessment of PK parameter: area under curve (AUC)	4 weeks
Number of participants with anti-drug antibodies	4 weeks
Number of participants with injection site reactions	4 weeks
Number of participants with lymphocyte depletion	4 weeks

Trial Locations

Locations (1)

Investigational Site Number 276001; 🇩🇪 Berlin, Germany