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    DRUG:

    Uplizna (inebilizumab-cdon)

    i
    Other names: MEDI-551, MEDI 551, 16C4-aFuc, A-fucosylated anti-CD19 antibody, VIB0551, MT-0551, VIB 0551, VIB-0551, MT0551, MT 0551, MEDI551
    Associations

    News

    Trials
    Company:
    Amgen, Jiangsu Hansoh Pharma, Mitsubishi Tanabe
    Drug class:
    CD19 inhibitor
    Related drugs:
    Associations

    News

    Trials
    5d
    Cellular and humoral vaccination response under immunotherapies-German consensus on vaccination strategies in neurological autoimmune diseases. (PubMed, Ther Adv Neurol Disord)
    The specific humoral and cellular response to vaccination can be compromised under alemtuzumab, azathioprine, cladribine, cyclophosphamide, CD19/CD20 antibodies (inebilizumab, ocrelizumab, ofatumumab, rituximab, ublituximab), dimethyl fumarate/diroximel fumarate, FcRn inhibitors (efgartigimod, rozanolixizumab), complement C5 inhibitors (eculizumab, ravulizumab, zilucoplan), interleukin-6 receptor antibodies (tocilizumab, satralizumab), intravenous immunoglobulins, long-term steroid administration, methotrexate, mitoxantrone, mycophenolate mofetil, tacrolimus, teriflunomide, tumor necrosis factor-α blockers, and sphingosine-1-phosphate receptor modulators (fingolimod, ozanimod, ponesimod, siponimod), as well as after autologous stem cell transplantation...However, the humoral and cellular vaccination response may be impaired under immunotherapy necessitating close monitoring. Here, we provide applicable recommendations to optimize immunization for individuals receiving immunotherapy due to a neurological autoimmune disease.
    Journal
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    IL6R (Interleukin 6 receptor)
    |
    Rituxan (rituximab) • cyclophosphamide • methotrexate • Campath (alemtuzumab) • mitoxantrone • cladribine • Arzerra (ofatumumab) • Briumvi (ublituximab-xiiy) • fingolimod • Actemra IV (tocilizumab) • Ocrevus (ocrelizumab) • Uplizna (inebilizumab-cdon)
    1m
    A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov)
    P2, N=15, Recruiting, Amgen | Initiation date: Nov 2025 --> Apr 2026
    Trial initiation date
    |
    Uplizna (inebilizumab-cdon)
    1m
    Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy (clinicaltrials.gov)
    P=N/A, N=60, Recruiting, Amgen | Trial completion date: Jul 2033 --> Oct 2032
    Trial completion date
    |
    Uplizna (inebilizumab-cdon)
    2ms
    A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov)
    P2, N=15, Recruiting, Amgen | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Uplizna (inebilizumab-cdon)
    2ms
    Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD (clinicaltrials.gov)
    P2, N=15, Not yet recruiting, Amgen
    New P2 trial
    |
    Uplizna (inebilizumab-cdon)
    3ms
    A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases (clinicaltrials.gov)
    P2, N=98, Recruiting, Amgen | N=140 --> 98 | Trial completion date: Apr 2028 --> Jun 2029 | Trial primary completion date: Jul 2027 --> Sep 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Blincyto (blinatumomab) • Uplizna (inebilizumab-cdon)
    3ms
    A Study of MT-0551 in Patients With Systemic Sclerosis (clinicaltrials.gov)
    P3, N=80, Active, not recruiting, Mitsubishi Tanabe Pharma Corporation | Trial completion date: Apr 2027 --> Aug 2026
    Trial completion date
    |
    Uplizna (inebilizumab-cdon)
    3ms
    Inectolizumab With Steroid Optimization in Newly Treated NMOSD (clinicaltrials.gov)
    P=N/A, N=25, Not yet recruiting, First Affiliated Hospital of Wenzhou Medical University
    New trial
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    Uplizna (inebilizumab-cdon) • methylprednisolone sodium succinate
    4ms
    STARGlu-NMO: Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD (clinicaltrials.gov)
    P3, N=170, Not yet recruiting, Tianjin Medical University General Hospital
    New P3 trial
    |
    Uplizna (inebilizumab-cdon)
    4ms
    A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases (clinicaltrials.gov)
    P2, N=140, Recruiting, Amgen | Trial completion date: Aug 2028 --> Apr 2028 | Trial primary completion date: Nov 2027 --> Jul 2027
    Trial completion date • Trial primary completion date
    |
    Blincyto (blinatumomab) • Uplizna (inebilizumab-cdon)
    5ms
    N-MOmentum LT: Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) (clinicaltrials.gov)
    P4, N=32, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Uplizna (inebilizumab-cdon)
    6ms
    ExTINGUSH: The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis (clinicaltrials.gov)
    P2, N=116, Recruiting, University of Utah | Trial completion date: Aug 2026 --> Sep 2028 | Trial primary completion date: Oct 2025 --> Sep 2028
    Trial completion date • Trial primary completion date
    |
    cyclophosphamide • Uplizna (inebilizumab-cdon)