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New drug shows promise for Sjögren's syndrome in early trial

NCT ID NCT04078386

Disease control Sponsor: RemeGen 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a biologic drug called RC18 in 42 people with primary Sjögren's syndrome, an autoimmune disease that causes dry eyes and mouth. Participants received weekly injections of either RC18 (at 160 mg or 240 mg) or a placebo for 24 weeks. The goal was to see if RC18 could safely reduce disease activity, measured by a standard score (ESSDAI). The study is complete, and results may show whether RC18 can help control this chronic condition.

What this could mean

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

Active substance
RC18 (a biologic drug that blocks a protein involved in immune system activity)
What this could lead to
If it works, this could lead to a new treatment option to control disease activity in people with primary Sjögren's syndrome.
What could go wrong
This is an early phase 2 trial with only 42 participants, so results may not apply to everyone. The drug may not prove effective or could have side effects.

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

42 people

The number who actually took part.

Started

Nov 2019

Finished

Oct 2021

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 65 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: * Voluntarily signed informed consent ; * Patient with primary Sjögren's syndrome according to the European - American consensus group criteria. * Seropositive at screening for anti-Ro/Sjögren's syndrome type A(SSA) antibodies * ESSDAI score ≥ 5. Exclusion Criteria: * Diagnosis of secondary Sjogren's syndrome, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis and other autoimmune diseases; * Abnormal laboratory parameters need to be excluded, including but not limited to: * Immunosuppressive agents were used within 4 weeks prior to randomization.; * The use of hydroxychloroquine was allowed during the trial, and the pre-randomized drug regimen was stable for less than 12 weeks; * Use of biological agents for targeted therapy in the first 6 months of randomization; * Treatment of primary Sjogren's syndrome with traditional Chinese medicine and proprietary Chinese medicine within 4 weeks before randomization; * The use of saliva-stimulating drugs within 7 days prior to randomization; * Sodium hyaluronate eye drops, artificial tears can be used, and the stability time of the randomized pre-medication scheme is less than 4 weeks; * Intravenous immunoglobulin therapy or plasma exchange therapy within 6 months before randomization; * Infection with herpes zoster or HIV and hepatitis C virus(HCV) antibody positive; * Currently suffering from active hepatitis or severe liver lesions and history; * Malignant tumor patients ; * Combined with involvement of important organs or neuropathy; * Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking the time for the shorter). * Pregnant , lactating women and men or women who have birth plans during the research; * Investigator considers candidates not appropriating for the study

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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

Locations

  • Beijing Hospital

    Beijing, China

  • Huzhou Third Municipal Hospital

    Huzhou, Zhejiang, China

  • Peking Union Medical College Hospital

    Beijing, China

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, China

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, China

  • The First Affiliated Hospital of USTC，Anhui Provincial Hospital

    Hefei, Anhui, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, China

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Tianjin Medical University General Hospital

    Tianjin, China

  • West China School of Medicine，West China Hospital of Sichuan University

    Chengdu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.