Low-dose IL-2 Treatment on Behcet's Disease

• Status: Unknown status
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to explore the clinical and immunological efficacy of low-dose IL-2 on Behcet's Disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Interleukin-2

Criteria

Inclusion Criteria:

1. Male or female ≥18 and ≤70 years of age at time of screening;

2. Diagnosis of Behcet disease defined by the International Study Group Criteria of 1989;

3. Patients who had active disease activity or intolerance after 3 months of conventional therapy; patients who had relapsed disease activity without treatment. Active manifestations including oral ulcers, genital ulcers, arthralgia, skin lesions and other systemic involvement manifestations. Intestinal BD-associated symptoms (abdominal pain, diarrhea, melena, etc.) and endoscopic evidence of active ulcers in the intestine. Aggravated visual acuity on a Snellen chart in at least one eye. Neurological BD (NBD) is classifies as either acute NBD (ANB) or chronic progressive NBD (CPNB) in accordance with the diagnostic criteria for NBD. Vascular BD (VBD) patients have active vasculitis lesions (deep vein thrombosis, aortic lesions, etc.) and abnormalities in inflammatory markers such as serum C-reactive protein (CRP) level and erythrocyte sedimentation rate (ESR) at enrollment.

4. Apply glucocorticoids (≤1.0mg/Kg*d prednisone or equivalent doses of other hormones) for 4 weeks. DMARDs ( methotrexate, hydroxychloroquine, azathioprine, morphine, leflunomide, cyclosporine, mycophenolate mofeti ) need to stable for 4 weeks. Other medications, such as, IVIg and cyclophosphamide need to more than 2 months, Rituximab for 6 months, other biological agents (infliximab, adalimumab, etanercept, anakinra, etc.) for 3 months.

5. Have given written informed consent and patients are expected to be able to comply with the requirements of the study follow-up plan and other protocols.

Exclusion Criteria:

1. Stable disease activity;

2. Received glucocorticoid >1.0mg/Kg*d within 4 weeks, used rituximab within 6 months and other biological agents within 3 months.

3. Severe comorbidities: including Heart failure (≥ grade III NYHA); Renal insufficiency (creatinine clearance ≤30 ml/min); Hepatic insufficiency (serum ALT or AST >3 times the ULN, or total bilirubin >ULN for the central laboratory conducting the test).

Other disease including hematopathy, gastrointestinal disease, endocrinopathy, pulmonary, neuropathy.

4. Known allergies, hypersensitivity, or intolerance to IL-2 or its excipients.

5. Severe infection, such as hepatitis, HIV, syphilis, pneumonia, bacteremia, cytomegalovirus and so on.

6. Malignancy;

7. Had uncontrolled psychiatric or emotional disorder;

8. Pregnant or breast-feeding.