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Can a pill tame Sjögren's? a new drug puts the immune system to the test

NCT ID NCT07727486

Disease control Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether an oral drug called ICP-488 can reduce disease activity in people with primary Sjögren's syndrome, an autoimmune condition that causes dry eyes, dry mouth, and fatigue. About 240 adults aged 18 to 70 with moderate-to-active disease will receive either ICP-488 or a placebo for 24 weeks. The main goal is to see if the drug lowers a standard measure of disease activity called ESSDAI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an oral drug called ICP-488
What this could lead to
If successful, ICP-488 could offer a new oral treatment option to control disease activity in Sjögren's syndrome.
What could go wrong
This is an early phase 2 trial with a moderate size of 240 participants. The drug may not prove more effective than placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary Sjögren's syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    22 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School"

    Nanjin, Jiangsu, 210008, China

  • "Southwest Hospital, Army Medical University （The First Hospital Affiliated to Army Medical University）"

    Chongqing, Chongqing Municipality, 400038, China

  • Bethune First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing, Chongqing Municipality, 400011, China

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000, China

  • Peking

    Beijing, Beijing Municipality, 100034, China

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200001, China

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

    Contact Email: •••••@•••••

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050005, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510630, China

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300192, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008, China

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412007, China

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