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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: IgG4 Related Disease

Treatments: Drug: Prednisone monotherapy; Drug: 10mg lenalidomide; Drug: 5mg lenalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT07068165

I-25PJ0175

Details and patient eligibility

About

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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 3 patient groups

5mg lenalidomide group

Experimental group

Description:

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)

Treatment:

Drug: 5mg lenalidomide

10 mg lenalidomide group

Experimental group

Description:

Lenalidomide 10mg/ day combined with prednisone, the initial dose of prednisone was 0.6-0.8mg/kg/ day for 2-4 weeks, then 5mg every 1-2 weeks until withdrawal (within 24 weeks).

Treatment:

Drug: 10mg lenalidomide

Prednisone monotherapy group

Active Comparator group

Description:

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).

Treatment:

Drug: Prednisone monotherapy