A Study to Evaluate the Efficacy and Safety of ICP-488 in Participants With Primary Sjögren's Syndrome

July 23, 2026 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Participants With Primary Sjögren's Syndrome (pSjS)

This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in participants with primary Sjögren's syndrome (pSjS).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400011
      • Chongqing, Chongqing Municipality, China, 400038
        • "Southwest Hospital, Army Medical University （The First Hospital Affiliated to Army Medical University）"
        • Contact:
    • Fujian
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510630
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050005
        • The Second Hospital of Hebei Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital of Central South University
        • Contact:
      • Zhuzhou, Hunan, China, 412007
    • Jiangsu
      • Nanjin, Jiangsu, China, 210008
        • "Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School"
        • Contact:
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Soochow University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Pingxiang, Jiangxi, China, 337055
    • Jilin
      • Changchun, Jilin, China, 130021
        • Bethune First Hospital of Jilin University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200001
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
      • Chengdu, Sichuan, China, 610072
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300192
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The second affiliated hospital of zhejiang university school of medicine
        • Contact:
      • Jinhua, Zhejiang, China, 321000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Aged 18 to 70 years inclusive.
  2. The disease duration (from the date of diagnosis) prior to screening shall be at least 24 weeks and no more than 5 years..
  3. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at screening is ≥ 5.
  4. At screening, the stimulated whole salivary flow (SWSF) ≥ 0.05 mL/min OR unstimulated whole salivary flow (UWSF) ≥ 0.01 mL/min.
  5. Positive for anti-Sjögren's-syndrome-related antigen A (anti-SSA/Ro) antibodies at screening.
  6. Stable treatment regimen that can be continued until the end of study treatment (Week 48).
  7. Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception correctly during the study treatment period and for 1 month (28 days) after the last dose.
  8. Male participants with a WOCBP partner must agree to use protocol-specified contraceptive methods during the study treatment period and for 3 days after the last dose.

Exclusion Criteria

  1. SjS secondary to other systemic autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis).
  2. Other autoimmune or inflammatory diseases that could interfere with the assessment of treatment response in SjS.
  3. Presence of any other medical condition associated with SjS symptoms.
  4. Participants with a history of any clinically significant disease other than pSjS.
  5. Significant ECG abnormalities at screening requiring treatment.
  6. Participants with gastrointestinal diseases or gastrointestinal surgery present within 3 months prior to the screening visit that could affect the absorption of the study drug.
  7. Current or past history of bleeding disorders or diseases related to platelet dysfunction.
  8. Severe infection (bacterial, fungal, or viral) requiring hospitalization within 60 days prior to screening.
  9. Participants with any uncontrolled clinically significant laboratory abnormality that, in the opinion of the investigator, could affect the interpretation of study data or the participant's participation in the study.
  10. Participants considered by the investigator to be unsuitable for participation in this study for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: ICP-488 Placebo
Drug: ICP-488 Placebo
Specified dose on specified days
Experimental: ICP-488 Dose A
Drug: ICP-488 Tablets
Specified dose on specified days
Experimental: ICP-488 Dose B
Drug: ICP-488 Tablets
Specified dose on specified days
Experimental: ICP-488 Dose C
Drug: ICP-488 Tablets
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in ESSDAI at each scheduled visit during the 24-week treatment period.
Time Frame: Baseline, Week 24
Baseline, Week 24
Percentage (%) of participants achieving a reduction from baseline in ESSDAI of ≥3 points at each scheduled visit during the 24-week treatment period.
Time Frame: Baseline, Week 24
Baseline, Week 24
Percentage (%) of participants with ESSDAI <5 at each scheduled visit during the 24-week treatment period.
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from baseline in ESSPRI at each scheduled visit during the 24-week treatment period.
Time Frame: Baseline, Week 24
Baseline, Week 24
Percentage (%) of participants achieving a reduction from baseline in ESSPRI of ≥1 point or 15% at each scheduled visit during the 24-week treatment period.
Time Frame: Baseline, Week 24
Baseline, Week 24
Treatment-emergent adverse events.
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Incidence of clinically significant abnormalities in laboratory test results, electrocardiograms (ECGs), vital signs, etc., and changes from baseline.
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Maximum Concentration at Steady State(Cmax,ss)
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Steady-State Time to Maximum
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Area under the curve (AUC)
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ICP-CL-01010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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