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

NCT04480307 | Completed Phase 2 Results DMC

• 2 other identifiers: GNC-4012019-004822-15
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Analysis of Adverse Events (AEs) focused on Treatment Emergent AEs (TEAEs)

  48 weeks

Secondary Outcomes (5)

• Neuroimaging

  48 weeks

• Neuroimaging

  48 weeks

• Neuroimaging

  48 weeks

• Neuroimaging

  48 weeks

• Neuroimaging

  48 weeks

Study Arms (4)

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 36 mg/kg

temelimab 54 mg/kg

EXPERIMENTAL

Monthly IV repeated dose

Drug: temelimab 54 mg/kg

Placebo

PLACEBO COMPARATOR

Monthly IV repeated dose

Drug: Placebo

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 36 mg/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

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

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

Results Point of Contact

• Title: David Leppert, Study director
• Organization: GeNeuro SA

dl@geneuro.com

225524800

Study Officials

• David Leppert, MD

  GeNeuro Innovation SAS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 10, 2020
• First Posted: July 21, 2020
• Study Start: June 17, 2020
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-08

Locations

SE (1)