A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.

Primary Sjögren Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830644
• Other study ID #: SIM 1910-08-?
• Status: Recruiting
• Phase: Phase 2
• Start date: March 22, 2021
• Est. completion date: June 2022

Study information

• Verified date: July 2021
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: Lai Zhiqiang
• Phone: +86-18697190725
• Email: laizhiqiang[@]simcere.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: June 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. Rituximab in the past 12 months prior to randomization;

2. Cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide and iguratimod in the past 12 weeks prior to randomization;

3. Azathioprine, cyclosporin, tacrolimus, sirolimus, sulfasalazine in the past 4 weeks prior to randomization;

4. 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.

Related Conditions & MeSH terms

• Primary Sjögren Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Iguratimod
Iguratimod orally twice a day
• Placebo
Placebo orally twice a day

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	Jilin Province People's Hospital	Changchun	Jilin
China	the First Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Heping Hospital Affiliated to Changzhi Medical College	Changzhi	Shanxi
China	Southern Medical University Nanfang Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The Affiliated Hospitalof Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	The Second Affiliated Hospital of Jiaxing University	Jiaxing	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Provincial Hospital Affliated to Shandong First Medical University	Jinan	Shandong
China	the First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	the Second Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Ningbo First Hospital	Ningbo	Zhejiang
China	the Shanghai Ninth People's Hospital	Shanghai	Shanghai
China	Tongji Hospital of Tongji University	Shanghai	Shanghai
China	Hebei General Hospital	Shijiazhuang	Hebei
China	the Second Hospital of HeBei Medical University	Shijiazhuang	Hebei
China	Shanxi Bethune hospital	Taiyuan	Shanxi
China	the Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin First Central Hospital	Tianjin	Tianjin
China	the First People's Hospital of Wenling	Wenling	Zhejiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	the Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Xinxiang Central Hospital	Xinxiang	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 12
Secondary	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.	Week 12
Secondary	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	Week 12
Secondary	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.	Week 12
Secondary	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	Week 12
Secondary	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	Week 12
Secondary	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	Week 12
Secondary	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	Week 12
Secondary	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	Week 12
Secondary	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	Week 12