A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate

Phase 1

Conditions: Relapsing-Remitting Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2017-001294-16-DE

Lead Sponsor: Alkermes, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 500

Inclusion Criteria

1. Capable of understanding and complying with the protocol
2. Male and female adults aged 18 to 65 years, inclusive
3. Has a confirmed diagnosis of RRMS
4. Neurologically stable with no evidence of relapse within 30 days prior to randomization (Visit 3)
5. Agrees to use a highly effective method of contraception for the duration of the study and for 30 days after any study drug administration or is surgically sterile or post-menopausal
6. Additional criteria may apply
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 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Have any finding(s) that would compromise the safety of the subject, affect the subject’s ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
2. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
3. History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal and/or other major disease that would preclude participation in a clinical trial
4. History of GI surgery (except appendectomy that occurred more than 6 months prior to screening; other prior surgeries may be permitted based on Medical Monitor approval)
5. History of clinically significant recurring or active gastrointestinal symptoms within 3 months of screening
6. Chronic use (=7 days) of medical therapy to treat any GI symptoms within 1 month of screening
7. Has a clinically significant medical condition or observed abnormality at screening
8. History of a myocardial infarction, including a silent myocardial infarction identified on ECG, or unstable angina
9. History of clinically significant drug or alcohol abuse within the past year prior to screening
10. Any of the following abnormal blood tests at screening (Visit 1):
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =2 times the upper limit of normal (ULN)
• Thyroid-stimulating hormone (TSH) level higher than the ULN by 10% or more at screening
• Estimated glomerular filtration rate (eGFR) =60 mL/min/1.73m2 (using the CKD EPI equation; (Levey, Stevens et al. 2009)
• Lymphocyte count <0.9 x 103/µL
11. Any of the following abnormal urine tests at screening (Visit 1):
• Beta-2 microglobulin >0.3 µg/mL
• Albumin to creatinine ratio >200 mg/g
12. Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
13. Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
14. Steroids, with the exception of topical or inhaled steroids, or IV
immunoglobulin within 30 days prior to randomization (Visit 3)
15. Prior treatment with Fumaderm or Tecfidera
16. Additional criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS;Secondary Objective: Not applicable;Primary end point(s): Number of days with GI events using the IGISIS questionnaire (relative to exposure days);Timepoint(s) of evaluation of this end point: 5 weeks

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Exposure time weighted GI symptom intensity using an individual GI symptom scale <br> 2. Number of days with overall GI symptoms using a global GI symptom scale <br> 3. Safety will be measured by incidence of adverse events (AEs)<br> ;Timepoint(s) of evaluation of this end point: 5 weeks

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