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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04830644
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 22, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Week 12 ]
    The change from baseline in the level of serum complement (C3 and C4) at all measured time points up to Week 12



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830644


Contacts
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Contact: Lai Zhiqiang +86-18697190725 laizhiqiang@simcere.com

Locations
Show Show 30 study locations
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
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Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04830644    
Other Study ID Numbers: SIM 1910-08-Ⅱ
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases