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

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04830644
• Collaborator: (none)
• Enrollment: 144
• Locations: 30
• Arms: 4
• Anticipated Duration (Months): 14.3
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Sjögren Syndrome	Drug: Iguratimod; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Mar 22, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) [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

Secondary Outcome Measures

1. Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) [Week 12]

   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.

2. Change From Baseline in the Unstimulated Salivary Flow [Week 12]

   The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Week 12

3. Change From Baseline in Schirmer's Test [Week 12]

   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.

4. Change From Baseline in the level of immunoglobulin (IgG, IgA, IgM) [Week 12]

   The change from baseline in the level of immunoglobulin (IgG, IgA, IgM) at all measured time points up to Week 12

5. Change From Baseline in the level of rheumatoid factor (RF) [Week 12]

   The change from baseline in the level of RF at all measured time points up to Week 12

6. Change From Baseline in the level of B -cell activation factor (BAFF) [Week 12]

   The change from baseline in the level of BAFF at all measured time points up to Week 12

7. Change From Baseline in the level of T/B/NK cell subsets [Week 12]

   The change from baseline in the level of T/B/NK cell subsets at all measured time points up to Week 12

8. Change From Baseline in the level of erythrocyte sedimentation rate (ESR) [Week 12]

   The change from baseline in the level of ESR at all measured time points up to Week 12

9. Change From Baseline in the level of serum complement (C3 and C4) [Week 12]

   The change from baseline in the level of serum complement (C3 and C4) at all measured time points up to Week 12

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing	Beijing	China	100032
2	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China
3	Southern Medical University Nanfang Hospital	Guangzhou	Guangdong	China	510000
4	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong	China	510000
5	the Second Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China
6	Hebei General Hospital	Shijiazhuang	Hebei	China
7	the Second Hospital of HeBei Medical University	Shijiazhuang	Hebei	China
8	the First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan	China
9	Xinxiang Central Hospital	Xinxiang	Henan	China
10	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China
11	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China	410000
12	The Affiliated Hospitalof Inner Mongolia Medical University	Hohhot	Inner Mongolia	China	010000
13	Jiangsu Province Hospital	Nanjing	Jiangsu	China
14	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China
15	Jilin Province People's Hospital	Changchun	Jilin	China	130000
16	the First Hospital of Jilin University	Changchun	Jilin	China
17	Shandong Provincial Hospital Affliated to Shandong First Medical University	Jinan	Shandong	China	250021
18	Qilu Hospital of Shandong University	Jinan	Shandong	China
19	the Shanghai Ninth People's Hospital	Shanghai	Shanghai	China
20	Tongji Hospital of Tongji University	Shanghai	Shanghai	China
21	Heping Hospital Affiliated to Changzhi Medical College	Changzhi	Shanxi	China
22	Shanxi Bethune hospital	Taiyuan	Shanxi	China
23	the Second Hospital of Shanxi Medical University	Taiyuan	Shanxi	China
24	the Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China
25	Tianjin First Central Hospital	Tianjin	Tianjin	China
26	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China
27	The Second Affiliated Hospital of Jiaxing University	Jiaxing	Zhejiang	China	314000
28	Ningbo First Hospital	Ningbo	Zhejiang	China	315010
29	the First People's Hospital of Wenling	Wenling	Zhejiang	China
30	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China

Sponsors and Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04830644
• Other Study ID Numbers: SIM 1910-08-Ⅱ
• First Posted: Apr 5, 2021
• Last Update Posted: Jul 19, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sjogren's Syndrome; Syndrome

Study Results

No Results Posted as of Jul 19, 2021