Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms⦠(NCT04480307) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis
Sweden41 participantsStarted 2020-06-17
Plain-language 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.
Who can participate
Age range18 Years ā 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, oā¦