Systemic Lupus ErythematosusPhase 2NCT02465580
A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus
A Phase 2 study testing hrIL-2 active in people with Systemic Lupus Erythematosus, run by Peking University People's Hospital at 1 site in China.
Trial summary
Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by the investigator's group, the investigators found that the Low-dose IL-2 was effective and well tolerated in active SLE, and the effect… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- hrIL-2 active
- 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
- Jun 2015to Dec 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the American College of Rheumatology criteria for the diagnosis of SLE，1997.
- Under standard treatment (≥ 2 months) at the time of inclusion
- Background treatment failed to control flares or to permit prednisone tapering
- With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria>0.5g/day), neuropsychiatric SLE.
- Positive for at least one of the following laboratory tests: ANA>1:160, anti-dsDNA, immunoglobulin>20g/L, decreased C3 or C4, leukopenia<3×10^9/L, thrombocytopenia<100×10^9/L;
- SLE disease activity index(SLEDAI) ≥ 8.
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- Negative HIV test.
- Negative for hepatitis B and C virus.
- Negative urine pregnancy test.
- Written informed consent form.
Who cannot join
- Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases> 3N) )
- Serious infection such as bacteremia, sepsis;
- Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
- High-dose steroid pulse therapy (>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
- History of administration of rituximab or other biologics;
- Purified protein derivative (tuberculin) >10mm
- Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
- Inability to comply with IL-2 treatment regimen.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Tian Liu, MD, 8613661345637, mikle317@163.com
About this study
Official title: A Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus
Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by the investigator's group, the investigators found that the Low-dose IL-2 was effective and well tolerated in active SLE, and the effect was associated with selective modulation of CD4+ T cell subsets.
This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE.
The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).
Read the detailed description
Each SLE patients (n=60) with Scores>=8 on SLEDAI received low-dose IL-2 or placebo (active group: placebo group =1:1, 1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety and clinical and immunologic response.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- hrIL-2 active, hrIL-2 placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hrIL-2 activeDrug
Also called Human recombinant IL-2
active group: placebo group =1:1
hrIL-2 placeboDrug
active group: placebo group =1:1
| Study group | Role | What they receive |
|---|---|---|
| hrIL-2 active | Active comparator | Intervention：Add hrIL-2 according to the protocol to original treatment. HrIL-2 active: 1 million U doses of human recombinant interleukin-2 s.c. injection Receives: Drug: hrIL-2 active |
| hrIL-2 placebo | Placebo comparator | 1 million U doses of placebo s.c. injection Receives: Drug: hrIL-2 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Were SLE Responders (SRI)
SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.
Measured: week 24
Evaluation of the safety (type and number of adverse events and serious adverse events) of low-doseIL-2 in patients with SLE
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, Beijing ShuangLu Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Zhanguo Li, Peking University People's Hospital
- Investigators
- Zhanguo Li, MD, Principal investigator, Peking University Institute of Rheumatology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465580
- Sponsor's protocol ID
- hrIL-2-SLE
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2015
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miao M, Xiao X, Tian J, Zhufeng Y, Feng R, Zhang R, Chen J, Zhang X, Huang B, Jin Y, Sun X, He J, Li Z. Therapeutic potential of targeting Tfr/Tfh cell balance by low-dose-IL-2 in active SLE: a post hoc analysis from a double-blind RCT study. Arthritis Res Ther. 2021 Jun 11;23(1):167. doi: 10.1186/s13075-021-02535-6.
PubMed 34116715Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PubMed 33687069He J, Zhang R, Shao M, Zhao X, Miao M, Chen J, Liu J, Zhang X, Zhang X, Jin Y, Wang Y, Zhang S, Zhu L, Jacob A, Jia R, You X, Li X, Li C, Zhou Y, Yang Y, Ye H, Liu Y, Su Y, Shen N, Alexander J, Guo J, Ambrus J, Lin X, Yu D, Sun X, Li Z. Efficacy and safety of low-dose IL-2 in the treatment of systemic lupus erythematosus: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2020 Jan;79(1):141-149. doi: 10.1136/annrheumdis-2019-215396. Epub 2019 Sep 19.
PubMed 31537547
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT02465580
- Acronym / sponsor ID
- hrIL-2-SLE
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Monash University, Beijing ShuangLu Pharmaceutical Co., Ltd.
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Jun 2015 (estimated)
- 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.
Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by the investigator's group, the investigators found that the Low-dose IL-2 was effective and well tolerated in active SLE, and the effect was associated with selective modulation of CD4+ T cell subsets.
This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE.
The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).
Detailed description
Each SLE patients (n=60) with Scores>=8 on SLEDAI received low-dose IL-2 or placebo (active group: placebo group =1:1, 1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety and clinical and immunologic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hrIL-2 active | Active comparator | Drug: hrIL-2 activeIntervention：Add hrIL-2 according to the protocol to original treatment. HrIL-2 active: 1 million U doses of human recombinant interleukin-2 s.c. injection |
| hrIL-2 placebo | Placebo comparator | Drug: hrIL-2 placebo1 million U doses of placebo s.c. injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Meet the American College of Rheumatology criteria for the diagnosis of SLE，1997.
- Under standard treatment (≥ 2 months) at the time of inclusion
- Background treatment failed to control flares or to permit prednisone tapering
- With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria>0.5g/day), neuropsychiatric SLE.
- Positive for at least one of the following laboratory tests: ANA>1:160, anti-dsDNA, immunoglobulin>20g/L, decreased C3 or C4, leukopenia<3×10^9/L, thrombocytopenia<100×10^9/L;
Key exclusion criteria (8 listed)
- Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases> 3N) )
- Serious infection such as bacteremia, sepsis;
- Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
- High-dose steroid pulse therapy (>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
- History of administration of rituximab or other biologics;
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 |
|---|---|---|
| hrIL-2 activeAlso: Human recombinant IL-2active group: placebo group =1:1 | Drug | hrIL-2 active |
| hrIL-2 placeboactive group: placebo group =1:1 | Drug | hrIL-2 placebo |
Primary outcome
Number of Participants Who Were SLE Responders (SRI)
Time frame: week 24
SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.
Evaluation of the safety (type and number of adverse events and serious adverse events) of low-doseIL-2 in patients with SLE
Time frame: 24 weeks
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Derived from this study: PubMed 34116715Miao M, Xiao X, Tian J, Zhufeng Y, Feng R, Zhang R, Chen J, Zhang X, Huang B, Jin Y, Sun X, He J, Li Z. Therapeutic potential of targeting Tfr/Tfh cell balance by low-dose-IL-2 in active SLE: a post hoc analysis from a double-blind RCT study. Arthritis Res Ther. 2021 Jun 11;23(1):167. doi: 10.1186/s13075-021-02535-6.
- Derived from this study: PubMed 33687069Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Derived from this study: PubMed 31537547He J, Zhang R, Shao M, Zhao X, Miao M, Chen J, Liu J, Zhang X, Zhang X, Jin Y, Wang Y, Zhang S, Zhu L, Jacob A, Jia R, You X, Li X, Li C, Zhou Y, Yang Y, Ye H, Liu Y, Su Y, Shen N, Alexander J, Guo J, Ambrus J, Lin X, Yu D, Sun X, Li Z. Efficacy and safety of low-dose IL-2 in the treatment of systemic lupus erythematosus: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2020 Jan;79(1):141-149. doi: 10.1136/annrheumdis-2019-215396. Epub 2019 Sep 19.
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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 principal investigator
Peking University Institute of Rheumatology and Immunology
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 hrIL-2 active in people with Systemic Lupus Erythematosus, run by Peking University People's Hospital 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 8 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: status not confirmed, as of the sponsor's last update on 8 Jun 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tian Liu, MD (8613661345637, mikle317@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Were SLE Responders (SRI) (time frame: week 24). The study lists 2 primary outcomes in all. 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 NCT02465580, which also lists 3 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 8 Jun 2015.