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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT04065672
• Date of registration: 20/08/2019
• Prospective Registration: Yes
• Primary sponsor: HeJing
• Public title: Low-dose IL-2 Treatment on Behcet's Disease
• Scientific title: Efficacy and Safety of Low-Dose Interleukin 2 for Behçet's Syndrome: a Phase 2, Randomised, Double-blind, Placebo-controlled Trial
• Date of first enrolment: October 12, 2021
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04065672
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Zhanguo Li, MD,PhD
• Affiliation: Department of Rheumatology and Immunology, Peking University People's Hospital.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female 18-70 years of age at time of screening.

2. Diagnosis of Behçet's Disease (according to the 1989 ICBD) for =3 months before
screening.

3. Active oral ulcer at time of screening.

4. 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

- glucocorticoids - 2 weeks

- DMARDs (including mmethotrexate, hydroxychloroquine, azathioprine, MMF,
leflunomide, and ciclosporin ) - 4 weeks

- IVIg or cyclophosphamide - 2 months

- Rituximab - 6 months

- other bDMARDs(e.g. Infliximab, Adalimumab, Enanercept etc.) - 12 weeks

5. 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.

Exclusion Criteria:

1. 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).

2. High-dose glucocorticoid (>1mg/kg/d) usage within 1 month.

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).

4. Other severe, progressive or uncontrolled hematologic, gastrointestinal, endocrine,
pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases
such as multiple sclerosis).

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

6. History of severe allergic reaction to monoclonal antibodies or to murine, chimeric,
or human proteins or their excipients.

7. 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.

8. 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.

9. Infected with HIV (positive serology for HIV antibody) or hepatitis C (positive
serology for Hep C antibody). If seropositive, consultation with a physician with
expertise in the treatment of HIV or hepatitis C virus infection was recommended.

10. Infected with hepatitis B virus. For patients who were not eligible for this study due
to hepatitis B virus test results, consultation with a physician with expertise in the
treatment of hepatitis B virus infection was recommended.

11. Had any known malignancy or has a history of malignancy within the previous 5 years
(with the exception of a nonmelanoma skin cancer that had been treated with no
evidence of recurrence for =3 months before the first study agent administration or
cervical neoplasia with surgical cure).

12. Had uncontrolled psychiatric or emotional disorder, including a history of drug and
alcohol abuse within the past 3 years that might prevent the successful completion of
the study.

13. Received, or was expected to receive, any live virus or bacterial vaccination within 3
months before the first administration of study agent, during the study, or within 4
months after the last administration of study agent. Had a BCG vaccination within 12
months of screening.

14. Pregnancy, lactation or women of child-bearing potential (WCBP) unwilling to use
medically approved contraception whilst receiving treatment and for 12 months after
treatment has finished.

15. Men whose partners are of child-bearing potential but who are unwilling to use
appropriate medically approved contraception whilst receiving treatment and for 12
months after treatment has finished.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Behcet's Disease

Intervention(s)

Drug: Low-dose IL-2

Drug: Placebo

Primary Outcome(s)

the number of oral ulcers at week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Change from baseline in the Behçet's Syndrome Activity Score [Time Frame: Week 12 and Week 24]

the change in pain from oral ulcers from baseline to week 12 [Time Frame: Week 12 and Week 24]

the percentage of patients with genital ulcers at baseline who were ulcer-free at week 12 [Time Frame: Week 12]

Change from baseline in simplified Behcet Disease Current Activity Form (BDCAF) Score [Time Frame: Week 12 and Week 24]

Change from baseline in Protocol-specific immunophenotypic analysis of peripheral blood lymphocyte subsets [Time Frame: Week 12 and Week 24]

the proportion of patients with a complete response to oral ulcers [Time Frame: Week 12]

the number of genital ulcers at week 12 and Week 24 [Time Frame: Week 12 and Week 24]

Secondary ID(s)

2019PHB089-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors