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

Phase 2

Withdrawn

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Drug: RNS60 125 ml; Drug: RNS60 250 ml; Drug: Interferon beta 1a

• Registration Number: NCT01714089
• Lead Sponsor: Revalesio Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-19
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-25
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RNS60 125 ml	RNS60 125 ml	125 ml of RNS60 administered weekly by IV infusion
RNS60 250 ml	RNS60 250 ml	250 ml of RNS60 administered weekly by IV infusion
Interferon beta-1a	Interferon beta 1a	Weekly dose of 30 mcg Interferon beta-1a (Avonex) administered by intramuscular injection.

Primary Outcome Measures

Name	Time	Method
Change in number of GAD-enhancing lesions from baseline	3, 4, 5, and 6 months	Cumulative number of GAD-enhancing lesions by MRI at months 3, 4, 5, and 6

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mt. Sinai School of Medicine; 🇺🇸 New York, New York, United States