Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BIIB019 subcutaneous injection, BIIB019 (Daclizumab), BIIB019 (Daclizumab High Yield Process), Daclizumab, Zinbryta
BIIB019 · 4 trials · 1 indication
Relapses are 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. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; ≤ 2.5 vs \> 2.5) and baseline age (≤ 35 vs \> 35 years). Data after participants switched to alternative MS medications are excluded.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.
For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.
Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.
For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.
Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Relapses are defined as new or recurrent neurologic 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 annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.
| Arm | Type | Description |
|---|---|---|
| Daclizumab High Yield Process 150 mg SC | EXPERIMENTAL | Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks |
| IFN β-1a 30 µg IM | ACTIVE_COMPARATOR | Interferon beta-1a (IFN β-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks |
| BIIB019 | EXPERIMENTAL | Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288. |
| Group 1: DAC HYP 150 mg | EXPERIMENTAL | Participants who received placebo in 205MS201 receive DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses. |
| Group 1: DAC HYP 300 mg | EXPERIMENTAL | Participants who received placebo in 205MS201 receive DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses. |
| Group 2: Washout then DAC HYP 150 mg | EXPERIMENTAL | Participants who received DAC HYP 150 mg SC injection in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 150 mg SC every 4 weeks for a total of 8 doses. |
| Group 2: DAC HYP 150 mg | EXPERIMENTAL | Participants who received DAC HYP 150 mg SC injection in 205MS201 receive DAC HYP 150 mg SC every 4 weeks for a total of 13 doses. |
| Group 3: Washout then DAC HYP 300 mg | EXPERIMENTAL | Participants who received DAC HYP 300 mg SC in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 300 mg SC every 4 weeks for a total of 8 doses. |
| Group 3: DAC HYP 300 mg | EXPERIMENTAL | Participants who received DAC HYP 300 mg SC in 205MS201 receive DAC HYP 300 mg SC every 4 weeks for a total of 13 doses. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks. |
| 150 mg DAC HYP | EXPERIMENTAL | Participants will receive 3 SC injections every 4 weeks for up to 52 weeks. |
| 300 mg DAC HYP | EXPERIMENTAL | Participants will receive 3 SC injections every 4 weeks for up to 52 weeks. |
| Name | Type | Description |
|---|---|---|
| BIIB019 (Daclizumab High Yield Process) | BIOLOGICAL | Daclizumab High Yield Process for subcutaneous injection |
| Interferon beta-1a Placebo | DRUG | Placebo to interferon beta-1a intramuscular injection |
| Interferon beta-1a | BIOLOGICAL | Interferon beta-1a for intramuscular injection |
| Daclizumab High Yield Process Placebo | DRUG | Placebo to Daclizumab High Yield Process subcutaneous injection |
| BIIB019 (Daclizumab) | BIOLOGICAL | Administered as specified in the treatment arm. |
| trivalent seasonal influenza vaccine | BIOLOGICAL | All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site |
| Placebo | DRUG | Placebo SC injection |
Key Inclusion Criteria: * Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS * Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive * Male ...
BIIB019 is being developed for the treatment of relapsing-remitting multiple sclerosis, a form of multiple sclerosis characterized by episodes of new or worsening neurological symptoms followed by periods of recovery. It is a monoclonal antibody studied in adult patients aged 18 years and older across four completed clinical trials.
BIIB019 is developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen sponsored the clinical development program for BIIB019 in relapsing-remitting multiple sclerosis, including the Phase 3 and Phase 2 studies conducted across multiple countries in North America, Europe, and Asia.
BIIB019 has completed Phase 3 clinical development for relapsing-remitting multiple sclerosis. Four trials have been completed, including one Phase 3 study and three Phase 2 studies, with no trials currently active. BIIB019 remains an investigational therapy and is not approved by the FDA.
BIIB019 has been evaluated in four completed trials: NCT01064401, a Phase 3 study versus interferon beta-1a with 1,841 participants; NCT01051349, a Phase 2 extension study with 410 participants; NCT00870740, a Phase 2 extension study with 517 participants; and NCT00390221, a Phase 2 study with 621 participants.
Yes, BIIB019 is also known as daclizumab, specifically daclizumab high yield process (DAC HYP). It is also referred to as BIIB019 subcutaneous injection. These names describe the same monoclonal antibody candidate developed by Biogen for relapsing-remitting multiple sclerosis.
The BIIB019 clinical program enrolled a total of 3,389 participants across four completed trials. All studies were randomized, double-blind, and placebo-controlled, and enrolled adults aged 18 years and older with relapsing-remitting multiple sclerosis. The largest trial, NCT01064401, accounted for 1,841 of those participants.