Uplizna (inebilizumab-cdon)

P1/2, N=2, Not yet recruiting, Amgen Inc.

P2, N=220, Recruiting, Amgen | N=98 --> 220 | Trial completion date: Jun 2029 --> Mar 2029 | Trial primary completion date: Sep 2028 --> Jan 2028

Maintenance therapy with steroid-sparing immunomodulators (e.g., azathioprine, mycophenolate mofetil) or B-cell depleting agents such as rituximab is often required. The anti-CD19 monoclonal antibody inebilizumab has emerged as a potent new option for maintaining remission. Maintaining a high index of clinical suspicion for IgG4-SC is essential in patients with obstructive jaundice and biliary strictures. Future efforts should focus on validating specific biomarkers (e.g., circulating plasmablasts, autoantibody profiles) and developing evidence-based protocols for long-term management to prevent fibrotic complications and reduce the relapse rate.

P1/2, N=4, Not yet recruiting, Amgen Inc.

P4, N=160, Not yet recruiting, Massachusetts General Hospital | Initiation date: Nov 2025 --> May 2026 | Trial primary completion date: Feb 2029 --> Jan 2030

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.

P2, N=15, Recruiting, Amgen | Initiation date: Nov 2025 --> Apr 2026

P=N/A, N=60, Recruiting, Amgen | Trial completion date: Jul 2033 --> Oct 2032

P2, N=15, Recruiting, Amgen | Not yet recruiting --> Recruiting

P2, N=15, Not yet recruiting, Amgen

P2, N=98, Recruiting, Amgen | N=140 --> 98 | Trial completion date: Apr 2028 --> Jun 2029 | Trial primary completion date: Jul 2027 --> Sep 2028

P3, N=80, Active, not recruiting, Mitsubishi Tanabe Pharma Corporation | Trial completion date: Apr 2027 --> Aug 2026