Behcet's DiseasePhase 2NCT04065672
Low-dose IL-2 Treatment on Behcet's Disease
A Phase 2 study testing Low-dose IL-2 in people with Behcet's Disease, run by HeJing at 1 site in China.
Trial summary
The study aims to explore the clinical and immunological efficacy of low-dose IL-2 on Behcet's Disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Behcet's Disease
- What is being tested?
- Low-dose IL-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2021to 28 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- glucocorticoids - 2 weeks
- DMARDs (including mmethotrexate, hydroxychloroquine, azathioprine, MMF, leflunomide, and ciclosporin ) - 4 weeks
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- IVIg or cyclophosphamide - 2 months
- Rituximab - 6 months
- other bDMARDs(e.g. Infliximab, Adalimumab, Enanercept etc.) - 12 weeks
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing
About this study
Official title: Efficacy and Safety of Low-Dose Interleukin 2 for Behçet's Syndrome: a Phase 2, Randomised, Double-blind, Placebo-controlled Trial
The study aims to explore the clinical and immunological efficacy of low-dose IL-2 on Behcet's Disease.
Read the detailed description
The investigators designed a single center, Phase 2, randomised, double-blind, placebo-controlled, parallel-group, superiority design study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines. After a 4-week screening period, patients were randomly assigned in a 1:1 ratio to receive IL-2 at a dose of 1 million IU or placebo subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study. After 12 weeks placebo-controlled treatment period, a 12-week observational followed up.
- Conditions
- Behcet's Disease
- Being tested
- Low-dose IL-2, Placebo
- Keywords
- Behçet's syndrome, LD-IL-2 therapy, Treg cells, T follicular cells, Th17 cells
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose IL-2Drug
After a 4-week screening period, patients received IL-2 at a dose of 1 million IU subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study with a 12-week observational followed up.
PlaceboDrug
After a 4-week screening period, patients received placebo subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study with a 12-week observational followed up.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose IL-2 | Experimental | After a 4-week screening period, patients received IL-2 at a dose of 1 million IU subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study with a 12-week observational followed up. Receives: Drug: Low-dose IL-2 |
| placebo | Placebo comparator | After a 4-week screening period, patients received placebo subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study with a 12-week observational followed up. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of oral ulcers at week 12
the number of oral ulcers at week 12
Measured: Week 12
Secondary outcomes (7)
the change in pain from oral ulcers from baseline to week 12
measured on a 100-mm visual-analogue scale (with 0 representing nopain and 100 the worst pain ever experienced),and the change in disease activity from baselineto week 12.
Measured: Week 12 and Week 24
Change from baseline in the Behçet's Syndrome Activity Score
a scaleon which scores range from 0 to 100, with higherscores indicating more active disease
Measured: Week 12 and Week 24
Change from baseline in simplified Behcet Disease Current Activity Form (BDCAF) Score
cores range from 0 to 12, withhigher scores indicating more active disease
Measured: Week 12 and Week 24
Change from baseline in Protocol-specific immunophenotypic analysis of peripheral blood lymphocyte subsets
Relative proportions of Treg, Tfh, Th1, Th2 and Th17 cell subsets were analyzed by flow cytometetry usingFACSAria III (BD) and FlowJo software (Tree Star). Treg cells were defined as CD3+ CD4+ CD25high CD127low, Tfh cells as CD3+ CD4+ CXCR5+ PD1high CCR7low6, Th1 cells as CD3+ CD4+ CXCR3+ CCR6- CCR4- CCR7low, Th2 cells as CD3+ CD4+ CXCR3+ CCR6- CCR4+ CCR7low and Th17 cells as CD3+ CD4+ CXCR3- CCR6+ CCR4+ CCR7low26.
Measured: Week 12 and Week 24
the number of genital ulcers at week 12 and Week 24
the number of genital ulcers at week 12 and Week 24
Measured: Week 12 and Week 24
the proportion of patients with a complete response to oral ulcers
the proportion of patients who had no oral ulcers at week 12
Measured: Week 12
the percentage of patients with genital ulcers at baseline who were ulcer-free at week 12
the percentage of patients with genital ulcers at baseline who were ulcer-free at week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start12 Oct 2021
- Primary completion20 Apr 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Behcet's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- HeJing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HeJing, Peking University People's Hospital
- Investigators
- Zhanguo Li, MD,PhD, Principal investigator, Department of Rheumatology and Immunology, Peking University People's Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065672
- Sponsor's protocol ID
- 2019PHB089-03
- Status last verified
- Apr 2024
- First submitted
- 20 Aug 2019
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunduz E, Teke HU, Bilge NS, Cansu DU, Bal C, Korkmaz C, Gulbas Z. Regulatory T cells in Behcet's disease: is there a correlation with disease activity? Does regulatory T cell type matter? Rheumatol Int. 2013 Dec;33(12):3049-54. doi: 10.1007/s00296-013-2835-8. Epub 2013 Aug 3.
PubMed 23912800Nanke Y, Kotake S, Goto M, Ujihara H, Matsubara M, Kamatani N. Decreased percentages of regulatory T cells in peripheral blood of patients with Behcet's disease before ocular attack: a possible predictive marker of ocular attack. Mod Rheumatol. 2008;18(4):354-8. doi: 10.1007/s10165-008-0064-x. Epub 2008 Apr 22.
PubMed 18427720Mohammadi M, Shahram F, Shams H, Akhlaghi M, Ashofteh F, Davatchi F. High-dose intravenous steroid pulse therapy in ocular involvement of Behcet's disease: a pilot double-blind controlled study. Int J Rheum Dis. 2017 Sep;20(9):1269-1276. doi: 10.1111/1756-185X.13095. Epub 2017 May 19.
PubMed 28524639Zou J, Ji DN, Shen Y, Guan JL, Zheng SB. Mucosal Healing at 14 Weeks Predicts better Outcome in Low-dose Infliximab Treatment for Chinese Patients with Active Intestinal Behcet's Disease. Ann Clin Lab Sci. 2017 Mar;47(2):171-177.
PubMed 28442519
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-Dose Interleukin 2 for Behçet's Syndrome: a Phase 2, Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04065672
- Acronym / sponsor ID
- 2019PHB089-03
- Conditions
- Behcet's Disease
- Keywords
- Behçet's syndrome, LD-IL-2 therapy, Treg cells, T follicular cells, Th17 cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HeJingUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to explore the clinical and immunological efficacy of low-dose IL-2 on Behcet's Disease.
Detailed description
The investigators designed a single center, Phase 2, randomised, double-blind, placebo-controlled, parallel-group, superiority design study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines. After a 4-week screening period, patients were randomly assigned in a 1:1 ratio to receive IL-2 at a dose of 1 million IU or placebo subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study. After 12 weeks placebo-controlled treatment period, a 12-week observational followed up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose IL-2 | Experimental | Drug: Low-dose IL-2After a 4-week screening period, patients received IL-2 at a dose of 1 million IU subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study with a 12-week observational followed up. |
| placebo | Placebo comparator | Drug: PlaceboAfter a 4-week screening period, patients received placebo subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study with a 12-week observational followed up. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose IL-2After a 4-week screening period, patients received IL-2 at a dose of 1 million IU subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study with a 12-week observational followed up. | Drug | Low-dose IL-2 |
| PlaceboAfter a 4-week screening period, patients received placebo subcutaneously every other day. After the initiation of the therapy, patients could continue with concurrent medication but were prohibited from changing or adding immunosuppression therapy during the course of the study with a 12-week observational followed up. | Drug | placebo |
Primary outcome
the number of oral ulcers at week 12
Time frame: Week 12
the number of oral ulcers at week 12
7 secondary outcomes
the change in pain from oral ulcers from baseline to week 12
Time frame: Week 12 and Week 24
Change from baseline in the Behçet's Syndrome Activity Score
Time frame: Week 12 and Week 24
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 number of genital ulcers at week 12 and Week 24
Time frame: Week 12 and Week 24
the proportion of patients with a complete response to oral ulcers
Time frame: Week 12
the percentage of patients with genital ulcers at baseline who were ulcer-free at week 12
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 23912800Gunduz E, Teke HU, Bilge NS, Cansu DU, Bal C, Korkmaz C, Gulbas Z. Regulatory T cells in Behcet's disease: is there a correlation with disease activity? Does regulatory T cell type matter? Rheumatol Int. 2013 Dec;33(12):3049-54. doi: 10.1007/s00296-013-2835-8. Epub 2013 Aug 3.
- Background: PubMed 18427720Nanke Y, Kotake S, Goto M, Ujihara H, Matsubara M, Kamatani N. Decreased percentages of regulatory T cells in peripheral blood of patients with Behcet's disease before ocular attack: a possible predictive marker of ocular attack. Mod Rheumatol. 2008;18(4):354-8. doi: 10.1007/s10165-008-0064-x. Epub 2008 Apr 22.
- Background: PubMed 28524639Mohammadi M, Shahram F, Shams H, Akhlaghi M, Ashofteh F, Davatchi F. High-dose intravenous steroid pulse therapy in ocular involvement of Behcet's disease: a pilot double-blind controlled study. Int J Rheum Dis. 2017 Sep;20(9):1269-1276. doi: 10.1111/1756-185X.13095. Epub 2017 May 19.
- Background: PubMed 28442519Zou J, Ji DN, Shen Y, Guan JL, Zheng SB. Mucosal Healing at 14 Weeks Predicts better Outcome in Low-dose Infliximab Treatment for Chinese Patients with Active Intestinal Behcet's Disease. Ann Clin Lab Sci. 2017 Mar;47(2):171-177.
- Primary outcome for BD patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanguo Li, MD,PhD principal investigator
Department of Rheumatology and Immunology, Peking University People's Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose IL-2 in people with Behcet's Disease, run by HeJing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of oral ulcers at week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065672, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.