Phase 3
Completed N=506
A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2
Source: ClinicalTrials.gov NCT03093324 ↗Enrolled (actual)
506
Serious AEs
1.4%
Results posted
Jul 2020
Primary outcomePrimary: Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B — 1.5; 2.5 days — p=0.0003
◆ Published Evidence
Highly cited
130citations · ~22 / year
Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study.
Summary
The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.
Linked Publications (3)
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Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study.
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Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study.
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Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: NEDA-3 After Re-Baselining in the Phase 3 EVOLVE-MS-1 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B |
1.5; 2.5 | 0.0003 sig |
| SECONDARY Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B |
1.3; 2.2 | 0.0007 sig |
| SECONDARY Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B |
2.9; 3.9 | 0.009 sig |
| SECONDARY Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B |
0.9; 1.5 | 0.009 sig |
| SECONDARY Number of Days With a Global GI Symptom and Impact Scale (GGISIS) Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B |
2.1; 2.8 | 0.033 sig |
| SECONDARY Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B |
1.1; 1.5 | 0.068 |
| SECONDARY Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B |
0.7; 0.9 | 0.215 |
| SECONDARY Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B |
0.9; 1.2; 0.2; 0.6; 0.8; 1.3 | 0.043 sig |
| SECONDARY Number of Participants With Adverse Events (AEs) |
198; 210 | — |
Eligibility Criteria
Key Inclusion Criteria
- Capable of understanding and complying with the protocol
- Has a confirmed diagnosis of RRMS
- Neurologically stable with no evidence of relapse within 30 days prior to randomization
- 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
Key Exclusion Criteria
- 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
- Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
- History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial
- History of GI surgery (except appendectomy that occurred more than 6 months prior to screening
- History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening
- Chronic use (7 days) of medical therapy to treat any GI symptoms within 1 month of screening Has a clinically significant medical condition or observed abnormality at screening
- History of a myocardial infarction, including a silent myocardial infarction or unstable angina
- History of clinically significant drug or alcohol abuse within the past year prior to screening
- Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
- 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
- Prior use of Dimethyl Fumarate (DMF)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03093324) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.