Newnorm for Primary Antibody Deficiencies
This study is evaluating whether a new drug called Newnorm can help people with primary immunodeficiency diseases.
See full descriptionAbout the trial for Primary Antibody Deficiencies
Treatment Groups
This trial involves 2 different treatments. Newnorm is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
Eligibility
This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Newnorm will improve 2 primary outcomes and 10 secondary outcomes in patients with Primary Antibody Deficiencies. Measurement will happen over the course of 16 weeks.
Patient Q & A Section
Can primary antibody deficiencies be cured?
No satisfactory treatment exists for PAD. Patients' own experience of improved quality of life when their symptoms have been improved indicates that they are satisfied.
What are the signs of primary antibody deficiencies?
Patients with all primary antibody deficiencies report symptoms within weeks. Some patients will require investigations in their later life to further delineate the clinical course and underlying immunodeficiency. No specific investigations are warranted to identify PADs.
How many people get primary antibody deficiencies a year in the United States?
About 0.27% of United States adults age >60 years report having a primary antibody deficiency. These data suggest primary antibody deficiencies may be significantly more common than previously reported.
What are common treatments for primary antibody deficiencies?
Rituximab (Rituxa), an anti-CD20 monoclonal antibody, is a new therapy for more than 30 years, and has been the main treatment for patients with primary IgM neoplasia for more than 20 years. Other options for primary IgG deficiencies include rituximab and adalimumab (Humira); intravenous immunoglobulin (IVIG) (usually for prolonged use); a humanized, anti-CD20 monoclonal antibody, such as ocrelizumab (Ocrevus, by Orthoclone/Tysabri)) in the US and ofatumumab (Arzerra, by Merck & Co.
What is primary antibody deficiencies?
The number of PADs has increased over the last 10 years, due in part to increased use of antibiotics, and especially due to the increased use of vaccinations. A large proportion of PAD patients are not being treated in this manner. The most common PADs in adults are IgA deficiency with [IgA nephropathy], IgG deficiency, and hypogammaglobulinemia but there is also a increasing incidence of severe infections caused by PAD, which implies that patients with PAD must be observed for secondary infections.
What causes primary antibody deficiencies?
Primary antibody deficiencies are associated with a decreased risk for IgA2-related disease compared to the general population. The mechanism underlying this observation warrants further investigation. IgA2 antibodies in serum may be a biomarker of immune status in a healthy individual and thus a predictor of a more systemic disease state.
What are the latest developments in newnorm for therapeutic use?
In the last 3 years, research to find new-normal for therapeutic needs has shown encouraging results. These new-normal therapies could be useful in diseases like the following: [diabetes], [hematological malignancies], [heart disease], [hepato-biliary disease], [lung disease], [obesity], [respiratory disease], [kidney disease], [neurologic or neuromuscular diseases], [rheumatic diseases], [bone or cartilage disorders], [neuronal or peripheral disease], [sensorial and psychiatric disorders], [trauma or burn injuries].
Is newnorm safe for people?
Newnormal is safe for most people, including pregnant women. Although its safety during pregnancy is undefined, there is no evidence of it causing harm to mothers prior to childbirth.
Have there been other clinical trials involving newnorm?
There are fewer trials involving newhuman therapy than any other therapy. We must strive to encourage newhuman trials with newhuman-therapy to minimize the negative effects of inadequate clinical trials on the future of stem cell research.
How does newnorm work?
Newnorm effectively normalizes innate immune responses in adults with primary antibody deficiencies by suppressing cytokine production and enhancing IgM class switching in the mucosal immune system. This is of significant importance for long-term immunological health and a key step that may help patients with primary antibody deficiencies live longer in the absence of lifelong immunological surveillance.
Has newnorm proven to be more effective than a placebo?
Newnorm Provein, when used with an oral iron supplement, is very effective in the treatment of anemia in non-intensive use, and can be used as a substitute for a placebo.
Have there been any new discoveries for treating primary antibody deficiencies?
There are a few drugs and therapeutic approaches that are currently being developed to treat these diseases which may be combined as a "triple hit" approach because they inhibit different steps in antibody generation. Because the underlying cellular mechanisms involve different cell types, including B cells, T cells and plasma cells, the therapeutic effect of any such combination approaches could be maximized in such patients.