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Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
Phase 3 trial testing Daclizumab in Relapsing-Remitting Multiple Sclerosis (RRMS) in 41 participants. Terminated before completion.
| Lead sponsor | Biogen |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 18 April 2017 |
| Primary completion | 12 September 2018 |
| Estimated completion | 12 September 2018 |
| Sites | 11 locations across Italy, Germany, Canada, Puerto Rico, United States |
Biogen — full company profile →
Adults 18 to 55, any sex, with Relapsing-Remitting Multiple Sclerosis (RRMS). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Daclizumab | 66.615 |
New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions were assessed using magnetic resonance imaging (MRI).
| Group | Value | 95% CI |
|---|---|---|
| Daclizumab | 3 |
New and newly enlarged T2 Hypointense Lesions were measured by MRI.
| Group | Value | 95% CI |
|---|---|---|
| Daclizumab | 3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Daclizumab | 27 |
| Group | Value | 95% CI |
|---|---|---|
| Daclizumab | 9 |
Clinical Laboratory assessments were tests of Chemistry and Hematology. The investigator determined if any of the laboratory results were clinically relevant shifts from Baseline.
| Group | Value | 95% CI |
|---|---|---|
| Daclizumab | 0 |
Time frame: First dose of study drug to within 30 days of last dose (up to 11 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Daclizumab |
|---|---|---|
| Multiple sclerosis relapse | Nervous system disorders | — |
| Lymphadenopathy | Blood and lymphatic system disorders | — |
| Gastrointestinal ulcer | Gastrointestinal disorders | — |
| Cholelithiasis | Hepatobiliary disorders | — |
| Encephalitis | Infections and infestations | — |
| Influenza | Infections and infestations | — |
| Oesophageal candidiasis | Infections and infestations | — |
| Subcutaneous abscess | Infections and infestations | — |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | — |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | — |
| Reaction | System | Daclizumab |
|---|---|---|
| Influenza | Infections and infestations | — |
| Injection site pain | General disorders | — |
| Multiple sclerosis relapse | Nervous system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Nasopharyngitis | Infections and infestations | — |
| Depression | Psychiatric disorders | — |
| Lymphadenopathy | Blood and lymphatic system disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Migraine | Nervous system disorders | — |
Most-reported serious reactions: Multiple sclerosis relapse, Lymphadenopathy, Gastrointestinal ulcer, Cholelithiasis, Encephalitis, Influenza, Oesophageal candidiasis, Subcutaneous abscess.
Data from ClinicalTrials.gov NCT02881567 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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