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Can a JAK inhibitor boost remission in IgG4-Related disease?

NCT ID NCT07827469

Disease control Sponsor: Peking University People's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether adding tofacitinib to prednisone works better than prednisone alone for people with active IgG4-related disease. The trial enrolls 58 adults with active disease and assigns them to either tofacitinib plus prednisone or prednisone alone. The main goal is to compare remission rates at 24 weeks, with secondary measures including recurrence, serum IgG4 levels, and side effects.

What this could mean

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

Active substance
tofacitinib, a Janus kinase inhibitor drug, added to prednisone
What this could lead to
If adding tofacitinib helps, it could offer a way to control IgG4-related disease with lower steroid doses and fewer steroid side effects.
What could go wrong
The trial is small and open label, so results may not hold up in larger blinded studies. Tofacitinib carries known risks of infection and other 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

58 people

The number who actually took part.

Started

Apr 2023

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. 18 ≤ Age ≤ 70 years old; 2. Complies with the 2019 ACR/EULAR IgG4 RD classification criteria 3. Patients with initial or recurrent active IgG4 RD (IgG4 RD RI ≥ 3 points). 4. Voluntary signing of informed consent: Patients must be given a written consent form when participating in the trial, and it is hoped that patients can comply with the requirements of the study follow-up plan and other protocols; 5. Female participants of childbearing age agreed to use effective contraceptive measures during the study period. Exclusion Criteria: 1. Participants in other trials or those who have participated in clinical trials of other drugs within 2 months; 2. Individuals who have received live vaccine immunization within 2 weeks prior to enrollment, or who require live vaccine immunization during the trial period; 3. Merge other autoimmune diseases 4. Active infected individuals need to be excluded. Latent tuberculosis requires prevention with isoniazid 0.3g/d one month in advance; People with hepatitis B HBsAg+and HBV-DNA negative need to take anti hepatitis B virus drugs one month in advance. 5. Pregnant and lactating women, or women of childbearing age who have fertility requirements during the study period and within 6 months after the last dose of medication; 6. Patients with a history of thromboembolism, or severe diseases such as coronary heart disease and other important organs such as the heart, brain, liver, lung, kidney, and hematopoietic system, malignant tumors, and psychiatric disorders; 7. Other researchers believe that it is not suitable for enrollment.

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Conditions

The condition(s) this trial relates to.

Immunoglobulin G4-Related Disease immunoglobulin G4-related sclerosing disease

As listed by the trial registrant

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

Immunoglobulin G4-related disease Janus kinase inhibitors

Contacts and locations

Locations

  • Peking Univercity, People's Hospital

    Beijing, Beijing Municipality, 100044, China

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