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

• Register: EUCTR
• Last refreshed on: 25 May 2020
• Main ID: EUCTR2017-001294-16-PL
• Date of registration: 29/06/2017
• Prospective Registration: Yes
• Primary sponsor: Alkermes, Inc.
• Public title: A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
• Scientific title: A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
• Date of first enrolment: 22/09/2017
• Target sample size: 420
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001294-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany, Poland, United States

Contacts

• Name: Regulatory Affairs
• Affiliation: Alkermes, Inc.

• Name: Regulatory Affairs
• Affiliation: Alkermes, Inc.

Key inclusion & exclusion criteria

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 an acceptable 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 475
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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


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

Health Condition(s) or Problem(s) studied

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

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

Intervention(s)

Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR)
Pharmaceutical Form: Capsule
INN or Proposed INN: Not available
Current Sponsor code: RDC-5108-00, ALKS8700
Other descriptive name: Diroximel Fumarate (DRF)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 231-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Tecfidera® 120 mg
Product Name: Tecfidera® 120 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Tecfidera
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Tecfidera® 240 mg
Product Name: Tecfidera® 240 mg
Pharmaceutical Form: Capsule
INN or Proposed INN: Tecfidera
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Evaluate the safety of ALKS 8700 and the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS

Secondary Objective: Not applicable

Primary end point(s): The number of days with any IGISIS individual symptom intensity score =2 relative to exposure days in Part A and Part B.

Timepoint(s) of evaluation of this end point: 5 weeks

Secondary Outcome(s)

Secondary end point(s): 1. Number of days with any IGISIS individual symptom intensity score =2 relative to exposure days in Part B
2. Number of days with any IGISIS individual symptom intensity score =1 relative to exposure days in Part A and Part B
3. Number of days with any IGISIS individual symptom intensity score =3 relative to exposure days in Part A and Part B
4. Number of days with a GGISIS symptom intensity score =1 relative to exposure days in Part A and Part B
5. Number of days with a GGISIS symptom intensity score =2 relative to exposure days in Part A and Part B
6. Number of days with a GGISIS symptom intensity score =3 relative to exposure days in Part A and Part B
7. Worst IGISIS individual symptom intensity score by week during the 5 week treatment period in Part A and Part B

Timepoint(s) of evaluation of this end point: 5 weeks

Secondary ID(s)

NCT03093324

ALK8700-A302

Source(s) of Monetary Support

Alkermes, Inc.

Ethics review

Status: Approved
Approval date: 11/07/2017
Contact: