Trial Outcomes & Findings for Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab (NCT NCT02881567)
NCT ID: NCT02881567
Last Updated: 2019-09-27
Results Overview
Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The Kaplan-Meier estimate of the percentage of participants relapse-free at Month 6 is reported.
TERMINATED
PHASE3
41 participants
Month 6
2019-09-27
Participant Flow
Participants enrolled in the study at 11 investigative sites in Canada, Germany, Italy, and the United States from 05 April 2017 to 12 September 2018.
Participants who discontinued treatment with natalizumab due to safety concerns were enrolled to receive daclizumab 150 milligrams (mg) per 1.0 milliliter (mL).
Participant milestones
| Measure |
Daclizumab
Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Daclizumab
Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Consent withdrawn
|
1
|
|
Overall Study
Investigator decision
|
1
|
|
Overall Study
Study terminated by sponsor
|
9
|
|
Overall Study
Reason not Specified
|
3
|
Baseline Characteristics
Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
Baseline characteristics by cohort
| Measure |
Daclizumab
n=41 Participants
Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
|
|---|---|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported Due to Confidentiality Regulation
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other (Aboriginal)
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: FAS included all participants enrolled in the study.
Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The Kaplan-Meier estimate of the percentage of participants relapse-free at Month 6 is reported.
Outcome measures
| Measure |
Daclizumab
n=41 Participants
Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
|
|---|---|
|
Percentage of Participants Relapse-free at Month 6
|
66.615 percentage of participants
|
SECONDARY outcome
Timeframe: Month 12Population: The study was terminated. No participants reached the 12-month time point.
Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Population: The study was terminated. No participants reached the 12-month time point.
Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Population: The study was terminated. No participants reached the 12-month time point.
Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of Month 12, and the ratio then multiplied by 365.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Months 6 and 12Population: FAS included all participants enrolled in the study. Number Analyzed is the number of participants with available assessment. No data was collected for T1 Hypointense Lesions at Month 6. No participants reached the 12-month time point since the study was terminated.
New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions were assessed using magnetic resonance imaging (MRI).
Outcome measures
| Measure |
Daclizumab
n=41 Participants
Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
|
|---|---|
|
Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12
Month 6, Gd+ Lesions
|
3 Participants
|
SECONDARY outcome
Timeframe: Months 6 and 12Population: FAS included all participants enrolled in the study. Number Analyzed is the number of participants with available assessment. No participants reached the 12-month time point since the study was terminated.
New and newly enlarged T2 Hypointense Lesions were measured by MRI.
Outcome measures
| Measure |
Daclizumab
n=41 Participants
Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
|
|---|---|
|
Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12
Month 6
|
3 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: The study was terminated. No participants reached the 12-month time point.
Permanent Discontinuation Rate was calculated as the ratio of number of participants who had permanently discontinued daclizumab prior to Month 12 over the total number of participants who received at least 1 dose of daclizumab in the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose of study drug to within 30 days of last dose (up to 11 months)Population: Safety Population included all enrolled participants who received at least 1 dose of study drug.
An AE can 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. An SAE is any untoward medical occurrence that at any dose results in death or in the view of the Investigator, places the participant at immediate risk of death or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability or results in a birth defect.
Outcome measures
| Measure |
Daclizumab
n=41 Participants
Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with AEs
|
27 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
9 Participants
|
SECONDARY outcome
Timeframe: First dose of study drug to within 30 days of last dose (up to 11 months)Population: Safety Population included all enrolled participants who received at least 1 dose of study drug.
Clinical Laboratory assessments were tests of Chemistry and Hematology. The investigator determined if any of the laboratory results were clinically relevant shifts from Baseline.
Outcome measures
| Measure |
Daclizumab
n=41 Participants
Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
|
|---|---|
|
Number of Participants With Clinically Relevant Shifts in Laboratory Assessments
|
0 Participants
|
Adverse Events
Daclizumab
Serious adverse events
| Measure |
Daclizumab
n=41 participants at risk
Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.4%
1/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
2.4%
1/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.4%
1/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Infections and infestations
Encephalitis
|
2.4%
1/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Infections and infestations
Influenza
|
2.4%
1/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Infections and infestations
Oesophageal candidiasis
|
2.4%
1/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Infections and infestations
Subcutaneous abscess
|
2.4%
1/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.4%
1/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Nervous system disorders
Multiple sclerosis relapse
|
4.9%
2/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
2.4%
1/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
Other adverse events
| Measure |
Daclizumab
n=41 participants at risk
Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.3%
3/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Gastrointestinal disorders
Nausea
|
12.2%
5/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
3/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
General disorders
Injection site pain
|
17.1%
7/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Infections and infestations
Influenza
|
22.0%
9/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
4/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Nervous system disorders
Migraine
|
7.3%
3/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Nervous system disorders
Multiple sclerosis relapse
|
17.1%
7/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
|
Psychiatric disorders
Depression
|
9.8%
4/41 • First dose of study drug to within 30 days of last dose (up to 11 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER