Background:
- Systemic Lupus Erythematosus (SLE or lupus) is an autoimmune disease, which means the
body's immune system mistakenly attacks healthy tissue resulting in inflammation and
tissue damage. SLE can involve almost any organ and its symptoms can range in severity
from mild to life-threatening; symptoms also vary from person to person. Current
treatments for lupus are not effective for some people. Medications used to treat lupus
can have serious side effects.
- Omalizumab is a drug that has been used to treat severe allergic asthma. It helps to
prevent allergic reactions by reducing some antibodies in the blood. These antibodies
are also present in some people with Lupus. Researchers want to see if omalizumab is a
safe and effective treatment for people with Lupus.
Objectives:
- To test the safety of omalizumab for people with lupus.
Eligibility:
- Individuals at least 18 years of age who have moderately active Lupus even with standard
treatments.
Design:
- Subject screening will take place at the NIH Clinical Center and will include a medical
history, a physical exam, blood and urine laboratory tests, an assessment of Lupus
disease activity. Some participants may require some additional testing. All eligible
persons who are interested in enrolling will be asked to come back to the NIH within 2
weeks to begin the study.
- The study will be conducted in three phases, with a total of 15 study visits over 38
weeks. Two visits will be overnight hospital stays. The rest will be outpatient visits.
During each visit the participants will be monitored by doing a physical exam,
assessment of their lupus disease activity, review of any treatment related side
effects, blood and urine testing.
- For the first phase, participants will have infusions (under their skin) of either
omalizumab or a placebo. They will have an overnight hospital stay for the first
infusion and then an outpatient safety monitor visit 2 weeks after. If subjects safety
measures are good they will return in 2 weeks and receive the second dose. They will
then get three more doses every 4 weeks which will be given during outpatient visits to
the NIH.
- In the second phase, which begins at the 16th week of the study, all participants will
receive omalizumab. This means that subjects who had been getting omalizumab will
continue receiving it and subjects who had been receiving the placebo will now begin
getting omalizumab. They will have an overnight hospital stay for this infusion and will
return in 2 weeks for a safety monitor visit. If subjects safety measures are good they
will return in 2 weeks and receive the next dose. They will then get three more doses
every 4 weeks which will be given during outpatient visits to the NIH.
- The third phase will be a final series of visits which will take place at week 32 and
week 36. During these visits subjects will have a physical exam which includes disease
activity assessment, blood and urine tests. No medication will be given during these
visits.
- All subjects will be given information, instruction and medications for possible
allergic reactions to omalizumab.
- Throughout the study other tests and procedures will be performed as needed.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator:
National Institute of Arthritis and Musculasketal and Skin Diseases