A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMS

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    400
  • sponsor
    Bosnalijek D.D
Updated on 3 March 2022
ACTH
rebif
magnetic resonance imaging brain

Summary

Multiple sclerosis is a chronic autoimmune, inflammatory neurological disease of the central nervous system. It is the most common disabling neurologic disease of young people. This study is planned for the evaluation of efficacy, safety and tolerability of neuropeptide combination of metenkefalin and tridecactide (EK-12) as compared to INF beta-1a (REBIF) in patients with RRMS. The primary objective of this study is to prove the superiority of efficacy of neuropeptide combination of metenkefalin and tridecactide (EK-12) compared to INF beta-1a (REBIF) in patients with RRMS on the basis of annualized protocol defined relapse rate by 144 weeks.

Details
Condition Multiple Sclerosis, Relapsing-Remitting
Treatment EK-12, INF beta-1a
Clinical Study IdentifierNCT03283397
SponsorBosnalijek D.D
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients from both genders with a confirmed and documented diagnosis of MS as defined by the Revised McDonald criteria (2010), with relapse onset disease or a relapsing-remitting disease course, between 18 and 55 years of age at screening (inclusive)
Ambulatory patients with EDSS score of 0 to 4.5 at both screening and randomization visits
Patients who meet one of the following disease activity criteria
At least 1 documented relapse within the last 12 months prior to screening or
At least 1 documented relapse occurred within the last 24 months prior to screening and documented evidence of at least 1 Gadolinium Enhancing (GdE) lesion on brain MRI scan within the last 12 months prior to randomization
Patients with a confirmed stable neurological condition, who are relapse-free and not on a corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH) treatment, at least 30 days prior to randomization
Women of child-bearing potential (e.g. women who are not postmenopausal or surgically sterilized) must practice an acceptable method of birth control for 30 days before taking the study drug and two acceptable methods of birth control during the duration of the study and until 30 days after the last dose of study medication. Acceptable methods of birth control include: intrauterine devices, barrier method (condom with spermicide or diaphragm with spermicide) and hormonal methods of birth control (e.g. oral contraceptive, contraceptive patch, and long-acting injectable contraceptive)
Patients must be able to sign and date a written Informed Consent Form (ICF) prior to entering the study
Patients must be willing and able to comply with the study protocol requirements for the duration of the study

Exclusion Criteria

Patients with progressive forms of MS
Patients with disease duration of 10 years
Inability to complete an MRI examination. Contraindications for MRI examination include but are not restricted to overweight, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc
Patients with neuromyelitis optica (NMO) or NMO spectrum disorders
Use of experimental or investigational drugs and/or participation in drug clinical studies within 6 months prior to randomization
Use of immunosuppressive agents or cytotoxic agents, including cyclophosphamide within 6 months prior to randomization
Use of either of the following agents within 2 years prior to randomization: natalizumab, rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab
Use of teriflunomide within 2 years prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to randomization
Previous treatment with glatiramer acetate, interferon-beta (either 1a or 1b), fingolimod, dimethyl fumarate or intravenous immunoglobulin (IVIG) within 2 months prior to randomization
Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 30 days prior to randomization
Previous use of mitoxantrone, cladribine, or alemtuzumab
Previous use of EK-12
Previous total body irradiation or total lymphoid irradiation
Previous stem cell treatment, autologous bone marrow transplantation or allogeneic bone marrow transplantation
Use of moderate/strong inhibitors of CYP3A4 within 2 weeks prior to randomization (Appendix VII provides a list of such medications that are disallowed prior to and during the study)
Use of inducers of CYP3A4 within 2 weeks prior to randomization (Appendix VII provides a list of such medications that are disallowed prior to and during the study)
Pregnancy or breastfeeding
Serum levels 3x upper limit of the normal range (ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at screening
Serum direct bilirubin 2x ULN at screening
Patients with clinically significant or unstable medical or surgical condition or any other condition that cannot be well controlled by the allowed medications permitted by the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, Electrocardiography (ECG), laboratory tests, MRI scan or chest X-ray. Such conditions may include
A major cardiovascular event (e.g. myocardial infarction, acute coronary syndrome, de-compensated congestive heart failure, pulmonary embolism, coronary revascularization) that occurred during the past 6 months prior to randomization
Any acute pulmonary disorder
A Central Nervous System (CNS) disorder other than MS that may jeopardize the patient's participation in the study, including such disorders that are demonstrated at the baseline MRI scan
Chronic renal insufficiency as Glomerular Filtration Rate (GFR) 60 mL/min at the screening visit
Patients who use haloperidol or dopamine antagonists
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