Omalizumab for Lupus

Summary

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.

Conditions

• Systemic Lupus Erthematosus
• Sjogren's Syndrome

Interventions

DRUG

Omalizumab

For each subject, treatment with omalizumab will start with a loading dose of 600 mg followed by a maintenance dose of 300 mg every 4 weeks. The study drug will be administered as a subcutaneous injection. On Week 0 and Week 16 the medication or placebo will be administered to subjects via 4 subcutaneous injections; the remaining weeks 2 injections will be administered.Subjects will be given written directions on dealing with adverse reactions. They will also receive an Epi-Pen before discharge and instructions on how to use it.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  lead NIH

Principal Investigators

• Sarfaraz A Hasni, M.D. · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-08

Primary Completion

2017-08-24

Completion

2017-08-24

FDA Drug

Yes

Countries

• United States

Study Locations