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

Simcere

Status and phase: Unknown; Phase 2

Conditions: Primary Sjögren Syndrome

Treatments: Drug: Iguratimod; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04830644

SIM 1910-08-Ⅱ

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 4 patient groups, including a placebo group

Iguratimod 1

Experimental group

Description:

orally 25mg twice a day

Treatment:

Drug: Iguratimod

Iguratimod 2

Experimental group

Description:

orally 20mg twice a day

Treatment:

Drug: Iguratimod

Iguratimod 3

Experimental group

Description:

orally 10mg twice a day

Treatment:

Drug: Iguratimod

Placebo

Placebo Comparator group

Description:

orally twice a day

Treatment:

Drug: Placebo