RecruitingPhase 2Phase 3NCT07068165

A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease

A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-RD


Sponsor

Peking Union Medical College Hospital

Enrollment

198 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

For patients with active proliferative IgG4-RD, we plan to conduct a 52-week prospective randomized controlled trial to compare the efficacy and safety of 5mg lenalidomide plus prednisone, 10mg lenalidomide plus prednisone, and prednisone alone, so as to find new treatment measures for patients with proliferative IgG4-RD.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 10mg lenalidomide, a drug called 5mg lenalidomide, and others for people with igg4-related disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG5mg lenalidomide

Lenalidomide 5mg/d combined with prednisone, prednisone at an initial dose of 0.6-0.8mg/kg/d for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks)

DRUG10mg lenalidomide

Lenalidomide 10mg/ day combined with prednisone, prednisone at an initial dose of 0.6-0.8mg/kg/ day for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks)

DRUGPrednisone monotherapy

The initial dose of prednisone was 0.6-0.8mg/kg/ day for 2-4 weeks, followed by 5mg every 1-2 weeks until withdrawal (within 24 weeks).


Locations(1)

Peking Union Medical College Hospital, Beijing, Beijing 100050

Beijing, China

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NCT07068165


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