A Pilot Study of XOMA 052 in Familial Cold Autoinflammatory Syndrome / Muckle-Wells Syndrome and Behcet's Disease

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Muckle Wells Syndrome, Autoinflammatory, Behcet's Disease

In brief

Background: * Autoinflammatory diseases are illnesses that produce episodes of inflammation such as fever, rash, or joint swelling. Some of these diseases can be treated with medications that block the body's reaction to a protein called IL-1, which may be part of the cause of the inflammation. IL-1 blocking agents are very helpful in treating autoinflammatory diseases and have become the standard of care for treatment for some of these diseases. However, more research is needed on related diseases that may be treated with new and currently used IL-1 blocking agents. * XOMA 052 is an experimental drug that is currently being tested as a possible treatment for type 2 diabetes. Initial studies have shown that XOMA 052 neutralizes a specific kind of IL-1, and is also active against certain indicators of inflammation. Researchers are interested in determining whether XOMA 052 can be used to treat autoinflammatory and related diseases. Objectives: \- To determine the effectiveness of XOMA 052 as a treatment for inflammation in adults with the autoinflammatory diseases Familial Cold Autoinflammatory Syndrome (FCAS)/Muckle-Wells Syndrome (MWS) and Behcet's Disease. Eligibility: * FCAS/ MWS: Individuals at least 18 years of age who have a known history of the typical disease. * Behcet's Disease: Individuals at least 18 years of age who have evidence of active disease, such as oral or genital ulcers or eye disease. Design: FCAS/MWS Participants * Participants will have an overnight evaluation of their disease, including optional tests (e.g., eye or skin exams). Participants who currently take medications to treat their symptoms will stop taking the medication and will be monitored by study researchers. At the first flare of symptoms, participants will begin to receive XOMA 052. * Participants will have further tests on days 3, 7, and 10 after the initial dose of XOMA 052. If the disease remains under good control, participants will have a clinical exam every 5 days for up to 10 weeks until another disease flare occurs (determined either by symptoms or by inflammation observed in laboratory studies). If the disease is not well controlled with the initial dose of XOMA 052, participants will have additional doses starting at day 7 until either the disease is controlled or researchers determine that the medication is not effective. * Participants will have the option to continue XOMA 052 treatments for up to 1 year. XOMA 052 wil...

Key facts

Study ID: NCT01211977
Run by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
People needed: 0
Starts: 2010-08-27
Expected to finish: 2011-04-29
Last updated by the study team: 2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

For both study populations:
Treatment with a live virus vaccine during 3 months prior to baseline visit. No live vaccines will be allowed throughout the course of this study.
Patients with ocular disease who received local treatments other than eye drops (i.e. periocular or intraocular steroids, implants or other antinflammatory agents within 4 weeks prior to enrollment)
Current treatment with TNF inhibitors or discontinuation of TNF inhibitors within 8 weeks.
Presence of active infections or a history of pulmonary TB infection with or without documented adequate therapy.
Chest x-ray read by a radiologist with pleural scarring and/or calcified granuloma consistent with prior TB.
Positive test for or prior history of HIV, Hepatitis B or C.
History or concomitant diagnosis of congestive heart failure.
History of malignancy. Subjects deemed cured of superficial malignancies such as cutaneous basal or squamous cell carcinomas, or in situ cervical cancer may be enrolled.
Known hypersensitivity to CHO cell derived biologicals or any components of XOMA 052.
Presence of any additional rheumatic disease or significant systemic disease. For example, major chronic infectious/ inflammatory/ immunologic disease (such as inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, SLE in addition to autoinflammatory disease).
Presence of any of the following laboratory abnormalities at enrollment visit: creatinine> 1.5 times the ULN, WBC< 3.6x10(9)/mm(3); platelet count < 75,000 mm(3); ALT or AST > 2.0 times the ULN
Lactating females or pregnant females.
Subjects with asthma not adequately controlled on current inhaled therapy for at least four weeks.
Enrollment in any other investigational treatment study or use of an investigational agent, or has not yet completed at least 4 weeks or 5 half-lives, whichever is longer, since ending another investigational device or drug trial.
Subjects for whom there is concern about compliance with the protocol procedures.
Presence of other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Treatment within the past 12 months with canakinumab
Active neurologic disease which would require cyclophosphamide treatment. Active neurologic disease is defined as either new evidence of parenchymal (meningoencephalitis) or non-parenchymal (vascular complications including thrombosis) disease.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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