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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Sjögren Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Iguratimod

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lai Zhiqiang; Phone Number: +86-18697190725; Email: laizhiqiang@simcere.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Peking University People's Hospital
  • Fujian
    • Xiamen, Fujian, China
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen Memorial Hospital
      • Contact: Yingqian Mo
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Southern Medical University Nanfang Hospital
      • Contact: Min Yang
  • Guangxi
    • Nanning, Guangxi, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Guangxi Medical University
      • Contact: Meiling li
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China
      • Not yet recruiting
      • Hebei General Hospital
      • Contact: Fengxiao Zhang
  • Henan
    • Luoyang, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science and Technology
    • Xinxiang, Henan, China
      • Not yet recruiting
      • Xinxiang Central Hospital
      • Contact: Wenqiang Fan
    • Zhengzhou, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • The second Xiangya Hospital of Central South University
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010000
      • Recruiting
      • The Affiliated Hospitalof Inner Mongolia Medical University
      • Contact: Ning Tie
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Jiangsu Province Hospital
      • Contact: Lei Gu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Lingyun Sun
  • Jilin
    • Changchun, Jilin, China
      • Not yet recruiting
      • The First Hospital of Jilin University
      • Contact: Zhenyu Jiang
    • Changchun, Jilin, China, 130000
      • Recruiting
      • Jilin Province People's Hospital
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Qilu Hospital of Shandong University
      • Contact: Huaxiang Liu
    • Jinan, Shandong, China, 250021
      • Recruiting
      • Shandong Provincial Hospital Affliated to Shandong First Medical University
      • Contact: Hongsheng Sun
  • Shanghai
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Tongji Hospital of Tongji University
      • Contact: Jianping Tang
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • the Shanghai Ninth People's Hospital
      • Contact: Futao Zhao
  • Shanxi
    • Changzhi, Shanxi, China
      • Recruiting
      • Heping Hospital Affiliated to Changzhi Medical College
      • Contact: Huiping Gong
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • The Second Hospital of Shanxi Medical University
    • Xi'an, Shanxi, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Xueyi Li
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin First Central Hospital
      • Contact: Wufang Qi
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Yasong Li
    • Jiaxing, Zhejiang, China, 314000
      • Recruiting
      • The Second Affiliated Hospital of Jiaxing University
      • Contact: Qiao Ye
    • Ningbo, Zhejiang, China, 315010
      • Recruiting
      • Ningbo First Hospital
      • Contact: Xiudi Wu
    • Wenling, Zhejiang, China
      • Not yet recruiting
      • The First People's Hospital of Wenling
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Li Sun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Iguratimod 1; orally 25mg twice a day	Drug: Iguratimod; Iguratimod orally twice a day
EXPERIMENTAL: Iguratimod 2; orally 20mg twice a day	Drug: Iguratimod; Iguratimod orally twice a day
EXPERIMENTAL: Iguratimod 3; orally 10mg twice a day	Drug: Iguratimod; Iguratimod orally twice a day
PLACEBO_COMPARATOR: Placebo; orally twice a day	Drug: Placebo; Placebo orally twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2021
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (ACTUAL): April 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: SIM 1910-08-Ⅱ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No