Sjögren's SyndromePhase 1/2NCT05605665
Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome
A Phase 1/2 study testing low-dose interleukin-2 and rapamycin in people with Sjögren's Syndrome, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjögren's Syndrome
- What is being tested?
- low-dose interleukin-2 and rapamycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2022to 31 Mar 2024
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, and aged 18-70 at the time of screening visit.
- Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria.
- If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment.
- Disease activity: ESSDAI≥4 points.
- The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline.
- The written informed consent form approved by the Ethics Committee of Peking University People's Hospital was signed and dated by the subject or legal representative.
Who cannot join
- Severe chronic liver, kidney and heart dysfunction.
- Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
- Patients with tumor and tumor history.
- Chronic respiratory failure.
- Patients who are ineffective in high-dose hormone pulse therapy.
- Those who use rituximab or other biological agents within 3 months.
- Patients with active tuberculosis infection or potential tuberculosis infection.
- There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university people's hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Therapeutic Effect of Low Dose IL-2 Combined With Rapamycin in on sjögren's Syndrome
The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome
Read the detailed description
A randomized, open clinical trial was designed. Patients will be randomly divided into three groups，including Ld-IL2 group, rapamycin group, Ld-IL2+rapamycin group. The improvement of clinical and laboratory indexes will be evaluated. Changes of immune cell subsets and cytokines will be monitored.
- Conditions
- Sjögren's Syndrome
- Being tested
- low-dose interleukin-2, rapamycin
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose interleukin-2Drug
Also called Recombinant Human Interleukin-2
low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once twice a week, for 12 weeks.
rapamycinDrug
Also called sirolimus
Rapamycin 0.5ml was taken orally once per day
| Study group | Role | What they receive |
|---|---|---|
| Low-dose interleukin-2 | Active comparator | One million IU of IL-2 was injected subcutaneously once twice a week for 12 weeks. Receives: Drug: low-dose interleukin-2 |
| Rapamycin | Active comparator | Rapamycin 0.5ml once per day for 12 weeks. Receives: Drug: rapamycin |
| Low-dose interleukin-2 and rapamycin | Experimental | One million IU of IL-2 was injected subcutaneously twice a week and rapamycin 0.5ml once per day for 12 weeks. Receives: Drug: low-dose interleukin-2; Drug: rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Treg cells in peripheral blood
Proportion of Treg cells in peripheral blood will be detected by flowcytometry
Measured: week 12
Secondary outcomes (4)
ESSDAI [potential score 0 - 123]
ESSDAI is [European League Against Rheumatism (EULAR) Sjögrens Syndrome Disease Activity Index]. Higher scores mean a worse outcome.
Measured: week 12
Physician's Global Disease Activity VAS, (potential score 0 - 10)
Physician's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome.
Measured: week 12
Patient's Global Disease Activity VAS, (potential score 0 - 80)
Patient's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis). Higher scores mean a worse outcome.
Measured: week 12
Rate of Participants with adverse effects associated with experimental drugs
Adverse effects include fever, rash, abnormal liver function, rate of new-onset infection and any abnormal measures associated with low-dose IL-2 therapy, and oral ulcer, rash, hypertension, anemia, arthralgia, diarrhea and any abnormal measures associated with rapamycin therapy.
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 posted4 Nov 2022
- Study start5 Dec 2022
- Primary completion30 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhanguo Li, Peking University People's Hospital
- Investigators
- Zhanguo Li, Study director, Peking university peoples hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605665
- Sponsor's protocol ID
- Rapa-IL2-SS
- Status last verified
- Jul 2024
- First submitted
- 29 Oct 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Low Dose IL-2 Combined With Rapamycin in on sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT05605665
- Acronym / sponsor ID
- Rapa-IL2-SS
- Conditions
- Sjögren's Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 4 Nov 2022 (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 purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome
Detailed description
A randomized, open clinical trial was designed. Patients will be randomly divided into three groups，including Ld-IL2 group, rapamycin group, Ld-IL2+rapamycin group. The improvement of clinical and laboratory indexes will be evaluated. Changes of immune cell subsets and cytokines will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose interleukin-2 | Active comparator | Drug: low-dose interleukin-2One million IU of IL-2 was injected subcutaneously once twice a week for 12 weeks. |
| Rapamycin | Active comparator | Drug: rapamycinRapamycin 0.5ml once per day for 12 weeks. |
| Low-dose interleukin-2 and rapamycin | Experimental | Drug: low-dose interleukin-2, Drug: rapamycinOne million IU of IL-2 was injected subcutaneously twice a week and rapamycin 0.5ml once per day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, and aged 18-70 at the time of screening visit.
- Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria.
- If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment.
- Disease activity: ESSDAI≥4 points.
- The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline.
Key exclusion criteria (8 listed)
- Severe chronic liver, kidney and heart dysfunction.
- Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
- Patients with tumor and tumor history.
- Chronic respiratory failure.
- Patients who are ineffective in high-dose hormone pulse therapy.
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 interleukin-2Also: Recombinant Human Interleukin-2low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU once twice a week, for 12 weeks. | Drug | Low-dose interleukin-2, Low-dose interleukin-2 and rapamycin |
| rapamycinAlso: sirolimusRapamycin 0.5ml was taken orally once per day | Drug | Low-dose interleukin-2 and rapamycin, Rapamycin |
Primary outcome
Proportion of Treg cells in peripheral blood
Time frame: week 12
Proportion of Treg cells in peripheral blood will be detected by flowcytometry
4 secondary outcomes
ESSDAI [potential score 0 - 123]
Time frame: week 12
Physician's Global Disease Activity VAS, (potential score 0 - 10)
Time frame: week 12
Patient's Global Disease Activity VAS, (potential score 0 - 80)
Time frame: week 12
Rate of Participants with adverse effects associated with experimental drugs
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 9 Jul 2024.
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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 study director
Peking university peoples hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing low-dose interleukin-2 and rapamycin in people with 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 6 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: finished, as of the sponsor's last update on 9 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Proportion of Treg cells in peripheral blood (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2024.