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Trial record 2 of 3 for:    ALKS 8700
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A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2

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ClinicalTrials.gov Identifier: NCT03093324
Recruitment Status : Completed
First Posted : March 28, 2017
Results First Posted : July 14, 2020
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Relapsing Remitting Multiple Sclerosis
Interventions Drug: ALKS 8700
Drug: Dimethyl Fumarate
Enrollment 506
Recruitment Details Participants were enrolled at 70 investigative sites in the United States (US), Germany, and Poland from March 15, 2017 to June 27, 2019.
Pre-assignment Details A total of 506 participants with relapsing remitting multiple-sclerosis were enrolled in this study. Of which 504 participants received study drug and randomized in Parts A and B of the study (253 participants in ALKS 8700 group and 251 in Dimethyl Fumarate group). A total of 478 participants completed the study.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5. Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
Period Title: Overall Study
Started [1] 254 252
Safety Population [2] 253 251
Completed 245 233
Not Completed 9 19
Reason Not Completed
Adverse Event             4             15
Lost to Follow-up             1             0
Protocol Deviation             2             2
Withdrawal by Subject             2             2
[1]
All enrolled participants.
[2]
All enrolled participants who received at least one dose of study drug.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF) Total
Hide Arm/Group Description Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5. Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5. Total of all reporting groups
Overall Number of Baseline Participants 253 251 504
Hide Baseline Analysis Population Description
The Safety population included all enrolled participants who had received at least one dose of study drug during the double-blind Treatment Period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 253 participants 251 participants 504 participants
43.7  (10.96) 43.7  (9.90) 43.7  (10.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 251 participants 504 participants
Female
177
  70.0%
190
  75.7%
367
  72.8%
Male
76
  30.0%
61
  24.3%
137
  27.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 251 participants 504 participants
Not Hispanic or Latino
248
  98.0%
241
  96.0%
489
  97.0%
Hispanic or Latino
5
   2.0%
10
   4.0%
15
   3.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 251 participants 504 participants
White
232
  91.7%
227
  90.4%
459
  91.1%
Black or African American
20
   7.9%
20
   8.0%
40
   7.9%
Other
0
   0.0%
2
   0.8%
2
   0.4%
Asian
0
   0.0%
1
   0.4%
1
   0.2%
Multiple races
1
   0.4%
0
   0.0%
1
   0.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.4%
1
   0.2%
1.Primary Outcome
Title 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
Hide Description IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Time Frame End of treatment (up to Week 6) for both Parts A and B
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description:
Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
Overall Number of Participants Analyzed 253 249
Mean (Standard Deviation)
Unit of Measure: days
1.5  (2.85) 2.5  (4.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Negative Binomial Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.542
Confidence Interval (2-Sided) 95%
0.390 to 0.754
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B
Hide Description IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Time Frame End of treatment (up to Week 6) for Part B
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description:
Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
Overall Number of Participants Analyzed 253 249
Mean (Standard Deviation)
Unit of Measure: days
1.3  (2.70) 2.2  (4.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Negative Binomial Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.520
Confidence Interval (2-Sided) 95%
0.356 to 0.760
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
Hide Description IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Time Frame End of treatment (up to Week 6) for both Parts A and B
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description:
Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
Overall Number of Participants Analyzed 253 249
Mean (Standard Deviation)
Unit of Measure: days
2.9  (4.46) 3.9  (5.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Negative Binomial Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.714
Confidence Interval (2-Sided) 95%
0.554 to 0.921
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
Hide Description IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
Time Frame End of treatment (up to Week 6) for both Parts A and B
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description:
Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
Overall Number of Participants Analyzed 253 249
Mean (Standard Deviation)
Unit of Measure: days
0.9  (2.25) 1.5  (3.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Negative Binomial Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.555
Confidence Interval (2-Sided) 95%
0.357 to 0.862
Estimation Comments [Not Specified]
5.Secondary Outcome
Title 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
Hide Description GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
Time Frame End of treatment (up to Week 6) for both Parts A and B
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as GGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description:
Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
Overall Number of Participants Analyzed 253 249
Mean (Standard Deviation)
Unit of Measure: days
2.1  (4.43) 2.8  (5.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method Negative Binomial Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.696
Confidence Interval (2-Sided) 95%
0.499 to 0.972
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B
Hide Description GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
Time Frame End of treatment (up to Week 6) for both Parts A and B
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as GGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description:
Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
Overall Number of Participants Analyzed 253 249
Mean (Standard Deviation)
Unit of Measure: days
1.1  (3.25) 1.5  (3.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments [Not Specified]
Method Negative Binomial Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.662
Confidence Interval (2-Sided) 95%
0.425 to 1.031
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
Hide Description GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
Time Frame End of treatment (up to Week 6) for both Parts A and B
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as GGISIS) on or before the last dose date. Number analyzed are the participants who were evaluated for this outcome measure.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description:
Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
Overall Number of Participants Analyzed 253 249
Mean (Standard Deviation)
Unit of Measure: days
0.7  (2.26) 0.9  (2.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.215
Comments [Not Specified]
Method Negative Binomial Regression Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.713
Confidence Interval (2-Sided) 95%
0.417 to 1.217
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B
Hide Description IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries. Scores were averaged for 5-week treatment period.
Time Frame End of treatment (up to Week 6) for both Parts A and B
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all enrolled participants in the Safety population who had at least one postbaseline GI tolerability assessment (such as IGISIS) on or before the last dose date.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description:
Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
Overall Number of Participants Analyzed 253 249
Mean (Standard Deviation)
Unit of Measure: score on a scale
Nausea 0.9  (1.55) 1.2  (1.98)
Vomiting 0.2  (0.74) 0.6  (1.84)
Upper Abdominal Pain 0.8  (1.58) 1.3  (2.06)
Lower Abdominal Pain 0.8  (1.60) 1.0  (1.84)
Diarrhea 1.1  (2.09) 1.3  (2.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Nausea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.6 to -0.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Vomiting: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.7 to -0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Upper Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-0.9 to -0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Lower Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.403
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALKS 8700, Dimethyl Fumarate (DMF)
Comments Diarrhea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.261
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.6 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame End of study (up to Week 10)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all enrolled participants who had received at least one dose of study drug during the double-blind Treatment Period.
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description:
Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.
Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
Overall Number of Participants Analyzed 253 251
Measure Type: Number
Unit of Measure: participants
198 210
Time Frame End of study (up to Week 10)
Adverse Event Reporting Description The Safety population included all enrolled participants who had received at least one dose of study drug during the double-blind Treatment Period.
 
Arm/Group Title ALKS 8700 Dimethyl Fumarate (DMF)
Hide Arm/Group Description Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5. Participants received DMF 120 mg along with DMF-matching placebo, oral capsules, BID for Week 1, followed by administration of DMF 240 mg and DMF-matching placebo, oral capsules, BID, for week 2 to 5.
All-Cause Mortality
ALKS 8700 Dimethyl Fumarate (DMF)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/253 (0.00%)   0/251 (0.00%) 
Hide Serious Adverse Events
ALKS 8700 Dimethyl Fumarate (DMF)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/253 (1.58%)   3/251 (1.20%) 
Cardiac disorders     
Atrial fibrillation † 1  1/253 (0.40%)  0/251 (0.00%) 
Hepatobiliary disorders     
Cholecystitis † 1  0/253 (0.00%)  1/251 (0.40%) 
Nervous system disorders     
Multiple sclerosis relapse † 1  3/253 (1.19%)  2/251 (0.80%) 
Psychiatric disorders     
Suicide attempt † 1  1/253 (0.40%)  0/251 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
ALKS 8700 Dimethyl Fumarate (DMF)
Affected / at Risk (%) Affected / at Risk (%)
Total   175/253 (69.17%)   191/251 (76.10%) 
Gastrointestinal disorders     
Abdominal pain † 1  16/253 (6.32%)  24/251 (9.56%) 
Abdominal pain lower † 1  15/253 (5.93%)  17/251 (6.77%) 
Abdominal pain upper † 1  17/253 (6.72%)  39/251 (15.54%) 
Diarrhoea † 1  39/253 (15.42%)  56/251 (22.31%) 
Nausea † 1  37/253 (14.62%)  52/251 (20.72%) 
Vomiting † 1  9/253 (3.56%)  22/251 (8.76%) 
General disorders     
Fatigue † 1  6/253 (2.37%)  13/251 (5.18%) 
Feeling hot † 1  4/253 (1.58%)  6/251 (2.39%) 
Infections and infestations     
Nasopharyngitis † 1  15/253 (5.93%)  11/251 (4.38%) 
Upper respiratory tract infection † 1  9/253 (3.56%)  9/251 (3.59%) 
Urinary tract infection † 1  8/253 (3.16%)  9/251 (3.59%) 
Investigations     
Alanine aminotransferase increased † 1  14/253 (5.53%)  9/251 (3.59%) 
Aspartate aminotransferase increased † 1  9/253 (3.56%)  5/251 (1.99%) 
Urine albumin/creatinine ratio increased † 1  6/253 (2.37%)  2/251 (0.80%) 
Nervous system disorders     
Headache † 1  10/253 (3.95%)  14/251 (5.58%) 
Multiple sclerosis relapse † 1  8/253 (3.16%)  5/251 (1.99%) 
Skin and subcutaneous tissue disorders     
Erythema † 1  20/253 (7.91%)  21/251 (8.37%) 
Generalised erythema † 1  4/253 (1.58%)  9/251 (3.59%) 
Pruritus † 1  18/253 (7.11%)  18/251 (7.17%) 
Pruritus generalised † 1  2/253 (0.79%)  6/251 (2.39%) 
Rash † 1  4/253 (1.58%)  6/251 (2.39%) 
Vascular disorders     
Flushing † 1  83/253 (32.81%)  102/251 (40.64%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Biogen Study Medical Director
Organization: Biogen
Phone: 866-633-4636
EMail: clinicaltrials@biogen.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03093324    
Other Study ID Numbers: ALK8700-A302
2017-001294-16 ( EudraCT Number )
First Submitted: March 16, 2017
First Posted: March 28, 2017
Results First Submitted: June 1, 2020
Results First Posted: July 14, 2020
Last Update Posted: July 14, 2020