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

NCT ID NCT07727486

Not yet recruiting Disease control Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. Source: ClinicalTrials.gov ↗

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.

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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

Contacts and locations

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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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