Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis

A Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple Sclerosis

The purpose of this study is to determine whether RNS60 is effective in the treatment of RR-MS compared to interferon beta-1a.

Study Overview

• Status: Withdrawn
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: Interferon beta 1a; Drug: RNS60 125 ml; Drug: RNS60 250 ml

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mt. Sinai School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males or females, aged between 18 and 50 years.
2. Diagnosis of RR-MS according to McDonald 2010 diagnostic criteria with a prior brain MRI that demonstrates lesions consistent with RRMS, both within the past year.
3. No evidence of relapse during the 60 days prior to enrollment.
4. EDSS score of 0-5 at screening.
5. Women of childbearing potential who have a negative pregnancy test (serum HCG) at screening.
6. Men or women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment.
7. Subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent.

Exclusion Criteria:

1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.
2. Normal baseline brain MRI.
3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
5. Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.
6. Steroid therapy within 60 days prior to enrollment, with the exception of corticosteroids or ACTH for relapse treatment during the course of the study.
7. Known allergy to Gadolinium-DTPA
8. Therapy with any immunomodulatory drugs within 3 months prior to enrollment, including but not limited to interferons, glatiramir acetate, BG-12, teriflunomide, laquinimod and IV immunoglobulin.
9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RNS60 125 ml; 125 ml of RNS60 administered weekly by IV infusion	Drug: RNS60 125 ml
Experimental: RNS60 250 ml; 250 ml of RNS60 administered weekly by IV infusion	Drug: RNS60 250 ml
Active Comparator: Interferon beta-1a; Weekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection.	Drug: Interferon beta 1a

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of GAD-enhancing lesions from baseline	Cumulative number of GAD-enhancing lesions by MRI at months 3, 4, 5, and 6	3, 4, 5, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of T2 lesions from baseline	Cumulative number of new or newly enlarged T2 lesions over 6 months of treatment	Months 3, 4, 5, and 6
Brain volume	Brain volume by MRI over 6 months of treatment	6 months
T2 lesion volume	T2 lesion volume by MRI over 6 months of treatment	6 month
Annualized Relapse Rate	Annualized Relapse Rate over 6 months	6 months
Expanded Disability Status Scale (EDSS), change from baseline	Progression of disability as assessed by the Expanded Disability Status Scale at months 3 and 6.	3, 6 months
Multiple Sclerosis Functional Composite, change from baseline	Progression of disability as assessed by the Multiple Sclerosis Functional Composite tool at months 3 and 6 months.	3, 6 months

Collaborators and Investigators

• Sponsor: Revalesio Corporation
• Investigators: Principal Investigator: Fred Lublin, MD, PhD, Mt. Sinai School of Medicine

Study record dates

Study Registration Dates

• First Submitted: October 19, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (Estimate): October 25, 2012

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Relapsing remitting multiple sclerosis; RR-MS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Pharmaceutical Solutions; Interferons; Interferon beta-1a; RNS60; Interferon-beta
• Other Study ID Numbers: 06.1.1.H1