The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04830644

Primary Sjögren Syndrome

UNKNOWN PHASE2

A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

NCT05817669

Primary Sjögren's Syndrome

COMPLETED PHASE2

Iguratimod in Systemic Sclerosis

NCT04515706

Systemic Sclerosis, Diffuse

UNKNOWN NA

To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom

NCT03368274

IgG4-related Disease

UNKNOWN PHASE4

A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

NCT02334306

Primary Sjögren's Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Sjögren's Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IGU Group

Group Type EXPERIMENTAL

Iguratimod Tablets

Intervention Type DRUG

Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.

HCQ Group

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine Sulfate Tablets

Intervention Type DRUG

Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iguratimod Tablets

Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.

Intervention Type DRUG

Hydroxychloroquine Sulfate Tablets

Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosed with pSS by meeting the 2016 ACR/EULAR Classification Criteria.
* The patient complained of dry mouth and eyes.
* Positive anti-SSA/Ro-60 antibody at screening.
* IgG≥16 g/L.
* No hormone, immunosuppressant, biological agents or other treatments were received within 4 weeks before screening;
* Pregnancy test of is negative. Use effective contraceptives during the trial (female)
* Those who did not participate in any drug trial within 12 weeks before enrollment

Exclusion Criteria

* Pregnant or lactating or planning to get pregnant during the duration of the study.
* Complicated with other CTD
* Complicated with malignancy
* mental illness, a history of alcohol abuse, immunodeficiency, uncontrolled infections, and drug or other substance abuse
* serious systemic damage, glucocorticoids, other immunosuppressants and biological agents should be added to control the condition: Heart, liver (transaminase/bilirubin \>1.5 times the upper normal limit), kidney (Cr≥133mmol/L), lung (FVC % \< 60%), blood (white blood cell \<3×109/L, HGB\<80g/L, PLT\<80×109/L), etc.
* Fundus/visual field lesions;
* Allergic to any component of the study drug (IGU and/or HCQ);
* the investigator considers the patient to be unsuitable for entry into the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No