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NCT Number: NCT07727486

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

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).

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Key information

Conditions

Primary Sjögren's Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 70 years inclusive.
  • The disease duration (from the date of diagnosis) prior to screening shall be at least 24 weeks and no more than 5 years..
  • The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at screening is ≥ 5.
  • At screening, the stimulated whole salivary flow (SWSF) ≥ 0.05 mL/min OR unstimulated whole salivary flow (UWSF) ≥ 0.01 mL/min.
  • Positive for anti-Sjögren's-syndrome-related antigen A (anti-SSA/Ro) antibodies at screening.
  • Stable treatment regimen that can be continued until the end of study treatment (Week 48).
  • 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.
  • 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

  • SjS secondary to other systemic autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis).
  • Other autoimmune or inflammatory diseases that could interfere with the assessment of treatment response in SjS.
  • Presence of any other medical condition associated with SjS symptoms.
  • Participants with a history of any clinically significant disease other than pSjS.
  • Significant ECG abnormalities at screening requiring treatment.
  • 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.
  • Current or past history of bleeding disorders or diseases related to platelet dysfunction.
  • Severe infection (bacterial, fungal, or viral) requiring hospitalization within 60 days prior to screening.
  • 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.
  • Participants considered by the investigator to be unsuitable for participation in this study for any reason.

Treatment and study plan

ICP-488 Tablets

Drug

Specified dose on specified days

ICP-488 Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Change from baseline in EULAR sjögren's syndrome disease activity index（ESSDAI ) at Week 24

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Change from baseline in ESSDAI at each scheduled visit during the 24-week treatment period.

    Time frame: Baseline, Week 24

  2. 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

  3. Percentage (%) of participants with ESSDAI <5 at each scheduled visit during the 24-week treatment period.

    Time frame: Baseline, Week 24

  4. Change from baseline in ESSPRI at each scheduled visit during the 24-week treatment period.

    Time frame: Baseline, Week 24

  5. 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

  6. Treatment-emergent adverse events.

    Time frame: Through study completion, an average of 1 year

  7. 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

  8. Maximum Concentration at Steady State(Cmax,ss)

    Time frame: Through study completion, an average of 1 year

  9. Steady-State Time to Maximum

    Time frame: Through study completion, an average of 1 year

  10. Area under the curve (AUC)

    Time frame: Through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Alexia Lu

CONTACT

[email protected]

010-66609745

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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