Primary Sjögren's SyndromePhase 2NCT02464319
A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome
A Phase 2 study testing hrIL-2 active in people with Primary Sjögren's Syndrome, run by Peking University People's Hospital at 1 site in China.
Trial summary
Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations may develop. Several immunomodulating agents have been attempted in the treatment of pSS without achieving satisfactory results. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Sjögren's Syndrome
- 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
- 1 Jun 2015to 31 Aug 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
- Diagnosis of a primary Sjögren´s Syndrome
- ESSDAI score ≥ 6
- Liver values above 1,5 ULN
- Stable low dose systemic use of Glucocorticoids（<=7.5mg） in the last 4 weeks before begin with Study medication
Who cannot join
- Secondary Sjögren's Syndrome
- Pre-treatment with Cyclosporine A
- Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimumab, other immunosuppressives
- Infection
- Neoplasia
- Relevant cardiac, pulmonary, neurologic or psychiatric disease
Show all 9Show fewer
- Life-Vaccination within 4 weeks before begin with study medication
- Pregnant or breast-feeding
- Weight under 45kg or more than 80kg
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Safety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's Syndrome
Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations may develop. Several immunomodulating agents have been attempted in the treatment of pSS without achieving satisfactory results. Currently, there is no approved systemic treatment for pSS. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active pSS patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in pSS. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in pSS. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for primary Sjögren's Syndrome by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).
Read the detailed description
Each pSS patients (n=60) with Scores>=6 on ESSDAI 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, clinical and immunologic response.
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- hrIL-2 active, hrIL-2 placebo
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
1 million U doses of human recombinant interleukin-2 s.c. injection active group: placebo group =1:1
hrIL-2 placeboDrug
Also called placebo
1 million U doses of placebo s.c. injection active group: placebo group =1:1
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 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 |
| Placebo Comparator: 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.
Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome
Measured: 24 weeks
Secondary outcomes (1)
Immunological Responses
Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study
Measured: 0,12,24weeks
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 start1 Jun 2015
- Primary completion31 Mar 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren's SyndromeStudies 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
- 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, PhD, Principal investigator, Peking University Institute of Rheumatology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464319
- Sponsor's protocol ID
- hrIL-2-SS1
- Status last verified
- Mar 2018
- First submitted
- 30 May 2015
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Feng R, Xiao X, Wang Y, Huang B, Chen J, Cheng G, Jin Y. Metabolic impact of low dose IL-2 therapy for primary Sjogren's Syndrome in a double-blind, randomized clinical trial. Clin Rheumatol. 2024 Dec;43(12):3789-3798. doi: 10.1007/s10067-024-07165-2. Epub 2024 Oct 31.
PubMed 39482484He J, Chen J, Miao M, Zhang R, Cheng G, Wang Y, Feng R, Huang B, Luan H, Jia Y, Jin Y, Zhang X, Shao M, Wang Y, Zhang X, Li J, Zhao X, Wang H, Liu T, Xiao X, Zhang X, Su Y, Mu R, Ye H, Li R, Liu X, Liu Y, Li C, Liu H, Hu F, Guo J, Liu W, Zhang WB, Jacob A, Ambrus JL Jr, Ding C, Yu D, Sun X, Li Z. Efficacy and Safety of Low-Dose Interleukin 2 for Primary Sjogren Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241451. doi: 10.1001/jamanetworkopen.2022.41451.
PubMed 36355371
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT02464319
- Acronym / sponsor ID
- hrIL-2-SS1
- Conditions
- Primary Sjögren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Monash University, Beijing ShuangLu Pharmaceutical Co., Ltd.
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- 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.
Primary Sjögren's Syndrome (pSS) is an autoimmune disorder characterized by keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular manifestations may develop. Several immunomodulating agents have been attempted in the treatment of pSS without achieving satisfactory results. Currently, there is no approved systemic treatment for pSS. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active pSS patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in pSS. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in pSS. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for primary Sjögren's Syndrome by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).
Detailed description
Each pSS patients (n=60) with Scores>=6 on ESSDAI 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, clinical and immunologic response.
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 |
|---|---|---|
| Experimental: 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 |
| Placebo Comparator: 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 (4 listed)
- Diagnosis of a primary Sjögren´s Syndrome
- ESSDAI score ≥ 6
- Liver values above 1,5 ULN
- Stable low dose systemic use of Glucocorticoids（<=7.5mg） in the last 4 weeks before begin with Study medication
Key exclusion criteria (9 listed)
- Secondary Sjögren's Syndrome
- Pre-treatment with Cyclosporine A
- Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimumab, other immunosuppressives
- Infection
- Neoplasia
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-21 million U doses of human recombinant interleukin-2 s.c. injection active group: placebo group =1:1 | Drug | Experimental: hrIL-2 active |
| hrIL-2 placeboAlso: placebo1 million U doses of placebo s.c. injection active group: placebo group =1:1 | Drug | Placebo Comparator: hrIL-2 placebo |
Primary outcome
Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome
Time frame: 24 weeks
1 secondary outcome
Immunological Responses
Time frame: 0,12,24weeks
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 15 Mar 2018.
- Derived from this study: PubMed 39482484Feng R, Xiao X, Wang Y, Huang B, Chen J, Cheng G, Jin Y. Metabolic impact of low dose IL-2 therapy for primary Sjogren's Syndrome in a double-blind, randomized clinical trial. Clin Rheumatol. 2024 Dec;43(12):3789-3798. doi: 10.1007/s10067-024-07165-2. Epub 2024 Oct 31.
- Derived from this study: PubMed 36355371He J, Chen J, Miao M, Zhang R, Cheng G, Wang Y, Feng R, Huang B, Luan H, Jia Y, Jin Y, Zhang X, Shao M, Wang Y, Zhang X, Li J, Zhao X, Wang H, Liu T, Xiao X, Zhang X, Su Y, Mu R, Ye H, Li R, Liu X, Liu Y, Li C, Liu H, Hu F, Guo J, Liu W, Zhang WB, Jacob A, Ambrus JL Jr, Ding C, Yu D, Sun X, Li Z. Efficacy and Safety of Low-Dose Interleukin 2 for Primary Sjogren Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241451. doi: 10.1001/jamanetworkopen.2022.41451.
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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
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 Primary Sjögren's Syndrome, 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 4 inclusion and 9 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 15 Mar 2018. 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?
Examination of the therapeutic effects (improvement in ESSDAI) of low dose IL-2 in patients with primary Sjögren's Syndrome (time frame: 24 weeks). 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 NCT02464319, which also lists 2 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 15 Mar 2018.