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Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (ProTEct-MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480307
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
GeNeuro SA ( GeNeuro Innovation SAS )

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: temelimab 18 mg/kg Drug: temelimab 36 mg/kg Drug: temelimab 54 mg/kg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS)
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: temelimab 18 mg/kg
Monthly IV repeated dose
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).

Experimental: temelimab 36 mg/kg
Monthly IV repeated dose
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).

Experimental: temelimab 54 mg/kg
Monthly IV repeated dose
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).

Placebo Comparator: Placebo
Monthly IV repeated dose
Drug: Placebo
Placebo will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).




Primary Outcome Measures :
  1. Safety and tolerability: adverse event [ Time Frame: 48 weeks ]
    To determine if temelimab treatment is associated with an increase of adverse event


Secondary Outcome Measures :
  1. Neuroimaging [ Time Frame: 48 weeks ]
    Change in brain parenchymal volume fraction at Week 48 compared to Baseline

  2. Neuroimaging [ Time Frame: 48 weeks ]
    Change in magnetization transfer (MTR) in periventricular NAWM at Week 48 compared to Baseline

  3. Neuroimaging [ Time Frame: 48 weeks ]
    Change in thalamic volume fraction at Week 48 compared to Baseline

  4. Neuroimaging [ Time Frame: 48 weeks ]
    Change in magnetization transfer (MTR) in cortex at Week 48 compared to Baseline

  5. Neuroimaging [ Time Frame: 48 weeks ]
    Change in T1 and T2 lesion volume at Week 48 compared to Baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main 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.

Main 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480307


Contacts
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Contact: David Leppert, MD 0041225524800 dl@geneuro.com
Contact: Nathalie Berthuy 0041225524800 nab@geneuro.com

Locations
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Sweden
Center for Neurology, Academic Specialist Center Recruiting
Stockholm, Sweden, 113 65
Contact: Fredrik Piehl         
Sponsors and Collaborators
GeNeuro Innovation SAS
Investigators
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Study Director: David Leppert, MD GeNeuro Innovation SAS
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Responsible Party: GeNeuro Innovation SAS
ClinicalTrials.gov Identifier: NCT04480307    
Other Study ID Numbers: GNC-401
2019-004822-15 ( EudraCT Number )
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GeNeuro SA ( GeNeuro Innovation SAS ):
Relapsing Forms of Multiple Sclerosis
GNbAC1
Human Endogenous Retrovirus Type W
HERV-W
Temelimab
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases