A Long-term Extension of Study GNC-401

NCT05049161 | Terminated Phase 2 DMC

• 2 other identifiers: GNC-4022021-001973-21
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Keywords

Relapsing Forms of Multiple Sclerosis; GNbAC1; Human Endogenous Retrovirus Type W; HERV-W; Temelimab

Outcome Measures

Primary Outcomes (1)

• safety and tolerability:adverse event

  Number of Patients With Treatment-Related Adverse Events

  48 weeks

Secondary Outcomes (5)

• Neuroimaging

  48 weeks

• Neuroimaging

  48 weeks

• Neuroimaging

  48 weeks

• Neuroimaging

  48 weeks

• Neuroimaging

  48 weeks

Study Arms (3)

Temelimab 18 mg/kg

EXPERIMENTAL

Monthly IV repeated dose

Drug: Temelimab 18 mg/kg

Temelimab 36 mg/kg

EXPERIMENTAL

Monthly IV repeated dose

Drug: Temelimab 36mg/kg

Temelimab 54 mg/kg

EXPERIMENTAL

Monthly IV repeated dose

Drug: Temelimab 54 mg/kg

Interventions

Temelimab 18 mg/kg DRUG

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

Temelimab 18 mg/kg

Temelimab 36mg/kg DRUG

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

Temelimab 36 mg/kg

Temelimab 54 mg/kg DRUG

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

Temelimab 54 mg/kg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient has given written informed consent to participate in the study;
• Current diagnosis of RMS, based on the McDonald 2017 criteria ;
• Patients must have completed study GNC-401. Completion is defined as having performed the Week 48 assessments of study GNC 401;
• Have no clinical (relapses) or MRI signs (≥2 new T2 lesions of \>10 mm diameter) of acute MS disease activity, based on the Week 48 MRI of study GNC 401, or, if yes, been retreated prior to study entry with rituximab;

You may not qualify if:

• The emergence of any disease diagnosis during the course of study GNC-401 that is not due to MS and could better explain the patient's neurological signs and symptoms;
• Body weight ≤40 kg;
• Contraindication to continue rituximab therapy;
• Has received rituximab less than 12 days prior to study entry;
• Use of any of the following medications since Week 48 of the GNC 401 study:
• Interferon (IFN) β, glatiramer acetate, IV immunoglobulin (IVIG), dimethyl fumarate or teriflunomide;
• Natalizumab, mitoxantrone, cladribine, alemtuzumab, cyclophosphamide, systemic cytotoxic therapy, total lymphoid irradiation, and/or bone marrow transplantation;
• Highly potent immune modulating therapy, such as: ocrelizumab, ofatumumab, fingolimod, siponimod, ozanimod or anti-cytokine therapy, plasmapheresis or azathioprine;
• Any experimental drugs for the treatment of MS;
• Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater lymphopenia (based on Week 48 of study GNC 401);
• Any major medical or psychiatric disorder that would affect the capacity of the patient to fulfill the requirements of the study, including:
• Diagnosis or history of schizophrenia;
• Current diagnosis of moderate to severe bipolar disorder, major depressive disorder, major depressive episode, history of suicide attempt, or current suicidal ideation;
• Current or past (within the last 2 years) alcohol or drug abuse;
• History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (New York Heart Association \[NYHA\] class 3 or 4);

Sponsors & Collaborators

• GeNeuro Innovation SAS: lead

Study Sites (1)

Center for Neurology, Academic Specialist Center

Stockholm, 113 65, Sweden

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

temelimab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Leppert, MD

  GeNeuro Innovation SAS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: August 31, 2021
• First Posted: September 17, 2021
• Study Start: August 27, 2021
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

SE (1)