CompletedPhase 2

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

China60 participantsStarted 2021-10-12

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female 18-70 years of age at time of screening.
✓. Diagnosis of Behçet's Disease (according to the 1989 ICBD) for ≥3 months before screening.
✓. Active oral ulcer at time of screening.
✓. Patients on corticosteroids (≤1 mg/kg/d prednisone or equivalent), DMARDs (e.g. methotrexate, hydroxychloroquine, azathioprine, MMF, leflunomide, ciclosporin etc.), must have been on a stable dose for 4 weeks prior to receiving the first infusion of study medication and expected to remain on this dose throughout the study. If the registered doctor plans to quit using current DMARDs or glucocorticoids, the washout period needs to be followed before patients join the groups. Each drug needs to meet the following washout period
✓. Given their written informed consent to participate in the trial and expected to be able to adhere to the study visit schedule and other protocol requirements.

✕. BD-related active major organ involvement requiring immunosuppressive therapy, e.g., pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis, recurrent malignant aneurysms), gastrointestinal (e.g., gastrointestinal ulcers), and central nervous system (e.g., meningoencephalitis).
✕. High-dose glucocorticoid (\>1mg/kg/d) usage within 1 month.
✕. 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 severe, progressive or uncontrolled hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
✕. Known allergies, hypersensitivity, or intolerance to IL-2 or its excipients.
✕. History of severe allergic reaction to monoclonal antibodies or to murine, chimeric, or human proteins or their excipients.
✕. Had a severe infection (including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis); had been hospitalized for an infection; or had been treated with IV antibiotics for an infection, within 2 months prior to the first administration of study agent.
✕. Chest radiograph within 3 months prior to the first administration of study agent that showed an abnormality suggestive of a malignancy or current active infection, including TB.

the number of oral ulcers at week 12

Timeframe: Week 12

NCT IDNCT04065672

SponsorHeJing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-20

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female 18-70 years of age at time of screening.
✓. Diagnosis of Behçet's Disease (according to the 1989 ICBD) for ≥3 months before screening.
✓. Active oral ulcer at time of screening.
✓. Patients on corticosteroids (≤1 mg/kg/d prednisone or equivalent), DMARDs (e.g. methotrexate, hydroxychloroquine, azathioprine, MMF, leflunomide, ciclosporin etc.), must have been on a stable dose for 4 weeks prior to receiving the first infusion of study medication and expected to remain on this dose throughout the study. If the registered doctor plans to quit using current DMARDs or glucocorticoids, the washout period needs to be followed before patients join the groups. Each drug needs to meet the following washout period
✓. Given their written informed consent to participate in the trial and expected to be able to adhere to the study visit schedule and other protocol requirements.

✕. BD-related active major organ involvement requiring immunosuppressive therapy, e.g., pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis, recurrent malignant aneurysms), gastrointestinal (e.g., gastrointestinal ulcers), and central nervous system (e.g., meningoencephalitis).
✕. High-dose glucocorticoid (\>1mg/kg/d) usage within 1 month.
✕. 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 severe, progressive or uncontrolled hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
✕. Known allergies, hypersensitivity, or intolerance to IL-2 or its excipients.
✕. History of severe allergic reaction to monoclonal antibodies or to murine, chimeric, or human proteins or their excipients.
✕. Had a severe infection (including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis); had been hospitalized for an infection; or had been treated with IV antibiotics for an infection, within 2 months prior to the first administration of study agent.
✕. Chest radiograph within 3 months prior to the first administration of study agent that showed an abnormality suggestive of a malignancy or current active infection, including TB.