Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis

NCT ID: NCT04480307

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-17
• Study Completion Date: 2022-01-24

Brief Summary

Randomized, double-blind, placebo-controlled Phase IIa clinical study, assessing safety, tolerability, pharmacodynamic effects and pharmacokinetics of temelimab, administered at three different dose levels (18 mg/kg or 36 mg/kg or 54 mg/kg).

In this study temelimab is administered subsequently to rituximab therapy, i.e. no co-administration of rituximab and temelimab is done in this study.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

temelimab 18 mg/kg

Monthly IV repeated dose

Group Type: EXPERIMENTAL

temelimab 18 mg/kg

Intervention Type: DRUG

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

temelimab 36 mg/kg

Monthly IV repeated dose

Group Type: EXPERIMENTAL

temelimab 36 mg/kg

Intervention Type: DRUG

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

temelimab 54 mg/kg

Monthly IV repeated dose

Group Type: EXPERIMENTAL

temelimab 54 mg/kg

Intervention Type: DRUG

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

Placebo

Monthly IV repeated dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).

Interventions

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).

Intervention Type: DRUG

temelimab 36 mg/kg

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

Intervention Type: 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).

Intervention Type: DRUG

Placebo

Placebo will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Current diagnosis of RMS, based on McDonald 2017 criteria
• Having received treatment with rituximab, as per local clinical routine for at least 12 months prior to the Screening Visit
• Having received their last dose of rituximab not more than 8 weeks and not less than 4 weeks before Randomization (Study Day 1)
• Having expanded disability status scale (EDSS) 2.5 - 5.5 inclusive at Screening
• Present clinical worsening in one or more neurological domains as assessed by EDSS, ambulatory function as assessed by 6MWT or T25FW, cognitive functioning as assessed by SDMT or increased need of walking aids or pharmacological/procedures for bowel and bladder functions over the last year.

Exclusion Criteria

• Current diagnosis of primary progressive MS (PPMS)
• Any disease other than MS (e.g. myelitis and /or bilateral optic neuritis) that could better explain the patient's signs and symptoms
• Usage of any of the following medications prior to the Screening visit:

• Any usage of interferon beta, glatiramer acetate, IV immunoglobulin (IVIG), dimethyl fumarate or teriflunomide within 12 months prior to Screening,
• Any history of exposure to mitoxantrone, cladribine, alemtuzumab, cyclophosphamide, systemic cytotoxic therapy, total lymphoid irradiation, and/or bone marrow transplantation at any time,
• Any usage of natalizumab within 24 months prior to Screening,
• Any usage of highly potent immune modulating therapy, such as: ocrelizumab, ofatumumab, fingolimod, siponimod, ozanimod or anti-cytokine therapy, plasmapheresis or azathioprine within 12 months prior to Screening,
• Any usage of any experimental treatment if not washed out for ≥ 5 half-lives or ≥ 12 months (whichever is longer), except rituximab which is allowed before the study.
• CTCAE Grade 2 or greater lymphopenia
• Any major medical or psychiatric disorder that would affect the capacity of the patient to fulfill the requirements of the study
• 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 (NYHA class 3 or 4)
• Any history of cancer with the exceptions of basal cell carcinoma and/or carcinoma in situ of the cervix, and only if successfully treated by complete surgical resection, with documented clean margins and any medically unstable condition as determined by the investigator
• Pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GeNeuro Innovation SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Leppert, MD

Role: STUDY_DIRECTOR

GeNeuro Innovation SAS

Locations

Center for Neurology, Academic Specialist Center

Stockholm, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-004822-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GNC-401

Identifier Type: -

Identifier Source: org_study_id