Primary Sjögren SyndromePhase 2NCT04830644
A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.
A Phase 2 study testing Iguratimod in people with Primary Sjögren Syndrome, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 30 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of iguratimod compared to placebo in patients with active primary Sjogren's Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sjögren Syndrome
- What is being tested?
- Iguratimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 30 sitesChina
- Study dates
- 22 Mar 2021to Jun 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjogren's Syndrome (EULAR SS)
- ESSDAI score ≥6
- IgG >16 g/L
- Positive anti-SS-A/Ro antibody at screening
Who cannot join
- Pregnancy or breast feeding
- Secondary Sjogren's syndrome
- severe renal or haematological failure, a history of cancer, hepatitis B or C, human immunodeficiency virus, severe diabetes or any other chronic disease or evidence of infection
- Prior administration of any of the following:
- Rituximab in the past 12 months prior to randomization;
- Cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide and iguratimod in the past 12 weeks prior to randomization;
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- Azathioprine, cyclosporin, tacrolimus, sirolimus, sulfasalazine in the past 4 weeks prior to randomization;
- live vaccine in the past 12 weeks prior to randomization
- Corticosteroids: > 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to randomization; Intramuscular, subcutaneous, intravenous, or intra-articular corticosteroids within 4 weeks prior to randomization.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites, 30 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100032
Zhanguo Li
- Recruiting
Jilin Province People's Hospital
Changchun, Jilin, 130000
Lin Chen
- Not yet recruiting
the First Hospital of Jilin University
Changchun, Jilin
Zhenyu Jiang
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Fen Li
- Recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi
Huiping Gong
- Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510000
Min Yang
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Yingqian Mo
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Yasong Li
- Recruiting
The Affiliated Hospitalof Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000
Ning Tie
- Recruiting
The Second Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, 314000
Qiao Ye
- Recruiting
Shandong Provincial Hospital Affliated to Shandong First Medical University
Jinan, Shandong, 250021
Hongsheng Sun
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Huaxiang Liu
- Recruiting
the First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Xiaofei Shi
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Lei Gu
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Lingyun Sun
- Not yet recruiting
the Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Meiling li
- Recruiting
Ningbo First Hospital
Ningbo, Zhejiang, 315010
Xiudi Wu
- Not yet recruiting
the Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality
Futao Zhao
- Not yet recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality
Jianping Tang
- Not yet recruiting
Hebei General Hospital
Shijiazhuang, Hebei
Fengxiao Zhang
- Recruiting
the Second Hospital of HeBei Medical University
Shijiazhuang, Hebei
Hongtao Jin
- Not yet recruiting
Shanxi Bethune hospital
Taiyuan, Shanxi
Liyun Zhang
- Not yet recruiting
the Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Xiaoxia Wang
- Recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality
Wufang Qi
- Not yet recruiting
the First People's Hospital of Wenling
Wenling, Zhejiang
Yongjun Cheng
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Li Sun
- Not yet recruiting
the Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Xueyi Li
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Guixiu Shi
- Not yet recruiting
Xinxiang Central Hospital
Xinxiang, Henan
Wenqiang Fan
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Shengyun Liu
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Iguratimod in Patients With Active Primary Sjogren's Syndrome.
The purpose of this study is to evaluate the efficacy and safety of iguratimod compared to placebo in patients with active primary Sjogren's Syndrome.
- Conditions
- Primary Sjögren Syndrome
- Being tested
- Iguratimod, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
Iguratimod orally twice a day
PlaceboDrug
Placebo orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| Iguratimod 1 | Experimental | orally 25mg twice a day Receives: Drug: Iguratimod |
| Iguratimod 2 | Experimental | orally 20mg twice a day Receives: Drug: Iguratimod |
| Iguratimod 3 | Experimental | orally 10mg twice a day Receives: Drug: Iguratimod |
| Placebo | Placebo comparator | orally twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.
Overall score, which can range from 0 to 123, a higher score indicates more disease activity
Measured: Week 12
Secondary outcomes (9)
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.
Total Score Range (0 = Best outcome and 10 = Worst Outcome)
The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.
Measured: Week 12
Change From Baseline in the Unstimulated Salivary Flow
The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Week 12
Measured: Week 12
Change From Baseline in Schirmer's Test
The Mean change from baseline in Schirmer's Test at all measured time points up to Week 12
The length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye.
Measured: Week 12
Change From Baseline in the level of immunoglobulin (IgG, IgA, IgM)
The change from baseline in the level of immunoglobulin (IgG, IgA, IgM) at all measured time points up to Week 12
Measured: Week 12
Change From Baseline in the level of rheumatoid factor (RF)
The change from baseline in the level of RF at all measured time points up to Week 12
Measured: Week 12
Change From Baseline in the level of B -cell activation factor (BAFF)
The change from baseline in the level of BAFF at all measured time points up to Week 12
Measured: Week 12
Change From Baseline in the level of T/B/NK cell subsets
The change from baseline in the level of T/B/NK cell subsets at all measured time points up to Week 12
Measured: Week 12
Change From Baseline in the level of erythrocyte sedimentation rate (ESR)
The change from baseline in the level of ESR at all measured time points up to Week 12
Measured: Week 12
Change From Baseline in the level of serum complement (C3 and C4)
The change from baseline in the level of serum complement (C3 and C4) at all measured time points up to 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 posted5 Apr 2021
- Study start22 Mar 2021
- Primary completionApr 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830644
- Sponsor's protocol ID
- SIM 1910-08-Ⅱ
- Status last verified
- Jul 2021
- First submitted
- 28 Mar 2021
- Last updated
- 19 Jul 2021
- 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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Iguratimod in Patients With Active Primary Sjogren's Syndrome.
- ClinicalTrials.gov ID
- NCT04830644
- Acronym / sponsor ID
- SIM 1910-08-Ⅱ
- Conditions
- Primary Sjögren Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 5 Apr 2021 (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 study is to evaluate the efficacy and safety of iguratimod compared to placebo in patients with active primary Sjogren's Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Iguratimod 1 | Experimental | Drug: Iguratimodorally 25mg twice a day |
| Iguratimod 2 | Experimental | Drug: Iguratimodorally 20mg twice a day |
| Iguratimod 3 | Experimental | Drug: Iguratimodorally 10mg twice a day |
| Placebo | Placebo comparator | Drug: Placeboorally twice a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjogren's Syndrome (EULAR SS)
- ESSDAI score ≥6
- IgG >16 g/L
- Positive anti-SS-A/Ro antibody at screening
Key exclusion criteria (9 listed)
- Pregnancy or breast feeding
- Secondary Sjogren's syndrome
- severe renal or haematological failure, a history of cancer, hepatitis B or C, human immunodeficiency virus, severe diabetes or any other chronic disease or evidence of infection
- Prior administration of any of the following:
- Corticosteroids: > 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to randomization; Intramuscular, subcutaneous, intravenous, or intra-articular corticosteroids within 4 weeks prior to randomization.
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 |
|---|---|---|
| IguratimodIguratimod orally twice a day | Drug | Iguratimod 1, Iguratimod 2, Iguratimod 3 |
| PlaceboPlacebo orally twice a day | Drug | Placebo |
Primary outcome
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Time frame: Week 12
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. Overall score, which can range from 0 to 123, a higher score indicates more disease activity
9 secondary outcomes
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Time frame: Week 12
Change From Baseline in the Unstimulated Salivary Flow
Time frame: Week 12
Change From Baseline in Schirmer's Test
Time frame: Week 12
Change From Baseline in the level of immunoglobulin (IgG, IgA, IgM)
Time frame: Week 12
Change From Baseline in the level of rheumatoid factor (RF)
Time frame: Week 12
Change From Baseline in the level of B -cell activation factor (BAFF)
Time frame: Week 12
Change From Baseline in the level of T/B/NK cell subsets
Time frame: Week 12
Change From Baseline in the level of erythrocyte sedimentation rate (ESR)
Time frame: Week 12
Change From Baseline in the level of serum complement (C3 and C4)
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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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.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iguratimod in people with Primary Sjögren Syndrome, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 30 sites 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: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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 Lai Zhiqiang (+86-18697190725, laizhiqiang@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) (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 19 Jul 2021.