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New drug combo aims to tame rare inflammatory disease

NCT ID NCT07068165

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding lenalidomide to standard steroid treatment can better control active IgG4-related disease (IgG4-RD), a rare condition that causes swelling and damage in organs. About 198 adults will receive either lenalidomide plus prednisone or prednisone alone for up to 52 weeks. The main goal is to see if the combination lowers the chance of the disease flaring up again.

What this could mean

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

Active substance
lenalidomide (a drug that modifies the immune system) combined with prednisone (a steroid)
What this could lead to
If successful, this could offer a new treatment option for people with active IgG4-related disease, potentially reducing relapses and allowing lower steroid doses.
What could go wrong
This is a mid-stage trial with only 198 participants, so results may not apply to everyone. Lenalidomide has known side effects like low blood counts and increased infection risk.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 198 people

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

Started

Jul 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

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 75 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. Patients aged between 18 and 75 years who meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for IgG4-RD； 2. Patients with active disease: For patients with initial treatment or relapse after drug withdrawal, active disease is defined as having an IgG4-RD Response Index (RI) of at least 2 points in at least one organ at the time of screening; for those experiencing relapse while on treatment, active disease is defined as having an IgG4-RD RI of at least 3 points in at least one organ at the time of screening； 3. Patients with the clinical subtype of proliferative IgG4-RD； 4. Patients who have no plans for pregnancy within the next 18 months and who agree to use reliable contraceptive measures during the study period； Exclusion Criteria: 1. IgG4-RD patients with only fibrotic features; 2. Absolute neutrophil count \<1.5×10\^9 /L or platelet count \<100×10\^9/L; 3. Creatinine clearance less than 60 ml/ min; 4. Liver function Child-Pugh grade B or above; 5. Chronic active infection requiring systemic treatment; 6. Diagnosed with malignant tumor in the past five years; 7. Patients with a history of thrombosis; 8. Using biological agents within six months; 9. Known to be allergic to lenalidomide or thalidomide; 10. Pregnant or lactating women; 11. Patients with any other medical conditions or for specific reasons judged by the investigator to be ineligible to participate in the study.

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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.

IgG4 related disease

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Peking Union Medical College Hospital, Beijing, Beijing 100050

    RECRUITING

    Beijing, China

More trials for these conditions

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