Treatment of Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis with RNS60 Administered Intravenously – a Phase IIa Clinical Trial

• Register: EUCTR
• Last refreshed on: 23 July 2018
• Main ID: EUCTR2014-000221-20-AT
• Date of registration: 25/06/2014
• Prospective Registration: Yes
• Primary sponsor: University Hospital Zürich
• Public title: Treatment of Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis with RNS60 Administered Intravenously – a Phase IIa Clinical Trial
• Scientific title: Treatment of Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis with RNS60 Administered Intravenously – a Phase IIa Clinical Trial
• Date of first enrolment: 23/10/2014
• Target sample size: 16
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000221-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: baseline-to-treatment comparison; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Switzerland

Contacts

• Name: Clinical Department of Neurology
• Affiliation: Innsbruck Medical University

• Name: Clinical Department of Neurology
• Affiliation: Innsbruck Medical University

Key inclusion & exclusion criteria

Inclusion criteria:
• Clinically isolated Syndrome or Relapsing-remitting MS (45, 46)

• Age 18 to 55 years inclusive

• EDSS at screening = 5.5.

• Disease duration = 10 years

• Patients are not eligible for standard therapies, or opted not to start or continue with any of the standard therapies.

• Patients are able to provide signed informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.

• To be eligible to proceed to the treatment phase of the study, patients must have = two CELs in the three sequential baseline MRI scans (average of =0.66 CELs).

• Patients cannot have a relapse during 30 days before initiation of treatment. If a relapse occurs during this period and eligibility criteria are otherwise fulfilled, treatment (day one) will be delayed until at least 30 days after receiving steroids. If corticosteroids are administered, the MRI during that period will not be considered. An additional MRI will be added at 4 weeks following the completion of corticosteroids, to maintain a total of three MRIs that are analyzed in the baseline period. In the event of relapse, the baseline period will be prolonged, as necessary, to meet these criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Diagnosis of secondary-progressive or primary-progressive MS, as defined by published diagnostic criteria (46).

• Abnormal screening/baseline blood tests exceeding any of the limits defined below:

• Serum alanine transaminase or aspartate transaminase levels, which are greater than three times the upper limit of normal values.
• Total white blood cell count < 3 000/mm3
• Platelet count < 85 000/mm3
• Serum creatinine level > 2.0 mg/dl, if serum creatinine level > 1.2 mg/dl, glomerular filtration rate must be determined, patients are excluded if it is <30ml/minute
• Positive pregnancy test
• Any other significant clinical abnormality

• Pregnant or breast-feeding female.

• History or signs of immunodeficiency.

• Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease.

• Inability to complete an MRI (contraindications for MRI include but are not restricted to known allergy to gadolinium contrast dyes, renal impairment which would contraindicate gadolinium injection, claustrophobia, weight =o140 kg, pacemaker, cochlear implants, 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 cognitive impairments, who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.

• If prior treatments were administered, the patient must be off treatment for the required period prior to enrollment as defined in the protocol.

• Prior treatment with other investigational drugs or procedures will be evaluated individually by the investigators.

• History of alcohol or drug abuse within the 5 years prior to enrolment.

• Female patients who are not post-menopausal or surgically sterile who are not using an acceptable method of contraception. Acceptability of various methods of contraception will be at the discretion of the investigator. Documentation that the patient is post-menopausal or surgically sterile must be available prior to enrolment.

• Male patients who are not surgically sterile and not practicing adequate contraception. Acceptability of various methods of contraception will be at the discretion of the investigator and will be discussed in details with all male patients during the informed consent procedure. Documentation that the patient is surgically sterile must be available prior to enrolment.

• Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient returning for follow-up visits on schedule.

• Previous participation in this study.

• Enrolment of the investigator, his/her family members, employees and other dependent persons.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Clinically Isolated Syndrome and Relapsing-remitting Multiple Sclerosis

Intervention(s)

Product Name: RNS60
Product Code: RNS60
Pharmaceutical Form: Infusion

Primary Outcome(s)

Secondary Objective: To determine the safety and tolerability of RNS60 administered intravenously in CIS and RR-MS.
- To assess the efficacy of RNS60 on secondary and tertiary outcome parameters consisting of clinical and MRI efficacy measures.
- To determine the efficacy of RNS60 on autoreactive T cells and other immune parameters and biomarkers.

Main Objective: To investigate the efficacy of RNS60 administered intravenously on MRI measurements of inflammatory disease activity in CIS and RR-MS patients.

Primary end point(s): The change in the mean number of CELs during weeks 8-16 (3 MRIs) compared to the mean total number of CELs during the three baseline MRIs (weeks -8 - 0; 3 MRIs).

Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Weeks 16, 24 and 32

Secondary end point(s): 1) Safety and tolerability measured by the occurrence of adverse events and serious adverse events (see stopping rules).
2) The average number of CELs in monthly MRIs at weeks 4-16 after treatment initiation compared to 3 monthly baseline MRIs prior to treatment (weeks -8 – 0).
3) The cumulative number of newly appearing T2 lesions (weeks 8-16 compared to weeks -8 - 0).

Secondary ID(s)

Nano-Cl_iv

Source(s) of Monetary Support

Revalesio Corp.