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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002820-10 | EudraCT Number |
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Study terminated in line with Biogen decision to withdraw Zinbryta from the market and not to pursue further studies of daclizumab in MS.
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
Not provided
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The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclizumab | Drug | High yield formulation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Relapse-free at Month 6 | 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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Relapse-free at Month 12 | 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. | Month 12 |
| Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12 |
Not provided
Key Inclusion Criteria
Key Exclusion Criteria
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tampa | Florida | 33612 | United States | ||
| Research Site |
Participants who discontinued treatment with natalizumab due to safety concerns were enrolled to receive daclizumab 150 milligrams (mg) per 1.0 milliliter (mL).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS) included all participants enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Relapse-free at Month 6 | 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. | FAS included all participants enrolled in the study. | Posted | Number | percentage of participants | Month 6 |
|
First dose of study drug to within 30 days of last dose (up to 11 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2018 | Sep 5, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 6, 2016 | Sep 5, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077561 | Daclizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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. |
| Month 12 |
| Annualized Relapse Rate (ARR) at Month 12 | 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. | Month 12 |
| Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12 | New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions were assessed using magnetic resonance imaging (MRI). | Months 6 and 12 |
| Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12 | New and newly enlarged T2 Hypointense Lesions were measured by MRI. | Months 6 and 12 |
| Permanent Discontinuation Rate of Daclizumab at Month 12 | 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. | Month 12 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | First dose of study drug to within 30 days of last dose (up to 11 months) |
| Number of Participants With Clinically Relevant Shifts in Laboratory Assessments | Clinical Laboratory assessments were tests of Chemistry and Hematology. The investigator determined if any of the laboratory results were clinically relevant shifts from Baseline. | First dose of study drug to within 30 days of last dose (up to 11 months) |
| Des Moines |
| Iowa |
| 50314 |
| United States |
| Research Site | Milwaukee | Wisconsin | 53501 | United States |
| Research Site | Edmonton | Alberta | T6G 2G3 | Canada |
| Research Site | Munich | Bavaria | 81675 | Germany |
| Research Site | Potsdam | Brandenburg | 14471 | Germany |
| Research Site | Dresden | Saxony | 01307 | Germany |
| Research Site | Hamburg | 20249 | Germany |
| Research Site | Pozzilli | Isernia | 86077 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Guaynabo | 00968 | Puerto Rico |
| Investigator decision |
|
| Study terminated by sponsor |
|
| Reason not Specified |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Participants Relapse-free at Month 12 | 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 study was terminated. No participants reached the 12-month time point. | Posted | Month 12 |
|
|
| Secondary | Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12 | 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 study was terminated. No participants reached the 12-month time point. | Posted | Month 12 |
|
|
| Secondary | Annualized Relapse Rate (ARR) at Month 12 | 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. | The study was terminated. No participants reached the 12-month time point. | Posted | Month 12 |
|
|
| Secondary | Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12 | New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions were assessed using magnetic resonance imaging (MRI). | 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. | Posted | Count of Participants | Participants | Months 6 and 12 |
|
|
|
| Secondary | Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12 | New and newly enlarged T2 Hypointense Lesions were measured by MRI. | 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. | Posted | Count of Participants | Participants | Months 6 and 12 |
|
|
|
| Secondary | Permanent Discontinuation Rate of Daclizumab at Month 12 | 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. | The study was terminated. No participants reached the 12-month time point. | Posted | Month 12 |
|
|
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety Population included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug to within 30 days of last dose (up to 11 months) |
|
|
|
| Secondary | Number of Participants With Clinically Relevant Shifts in Laboratory Assessments | Clinical Laboratory assessments were tests of Chemistry and Hematology. The investigator determined if any of the laboratory results were clinically relevant shifts from Baseline. | Safety Population included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | First dose of study drug to within 30 days of last dose (up to 11 months) |
|
|
|
| 0 |
| 41 |
| 9 |
| 41 |
| 23 |
| 41 |
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Encephalitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
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.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Month 12, Gd+ Lesions |
|
| Month 12, T1 Hypointense Lesions |
|