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A Long-term Extension of Study GNC-401

NCT05049161 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-07-07

No results posted yet for this study

Summary

This Phase II study is a monocenter, long-term extension study of study GNC-401 and will start after individual completion of Week 48 of the GNC-401 study. At entry, all patients will receive active treatment with temelimab. The patients of the placebo group in study GNC-401 will be re-randomized to temelimab 18 mg/kg, 36 mg/kg or 54 mg/kg (1:1:1), while the patients who received temelimab in study GNC-401 will continue with the same dose in study GNC-402. Following final analysis of the results of the GNC-401 study, the Sponsor may switch all patients to an optimal dose of temelimab based on safety and efficacy demonstrated in the GNC-401 study.

Conditions

Interventions

DRUG

Temelimab 18 mg/kg

temelimab 18 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)

DRUG

Temelimab 36mg/kg

temelimab 36 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)

DRUG

Temelimab 54 mg/kg

temelimab 54 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)

Sponsors & Collaborators

  • GeNeuro Innovation SAS

    lead INDUSTRY

Principal Investigators

  • David Leppert, MD · GeNeuro Innovation SAS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2022-05-18
Completion
2022-05-18

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05049161 on ClinicalTrials.gov