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

NCT ID: NCT07068165

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2028-08-20

Brief 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.

Conditions

IgG4 Related Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5mg lenalidomide group

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)

Group Type: EXPERIMENTAL

5mg lenalidomide

Intervention Type: DRUG

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)

10 mg lenalidomide group

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).

Group Type: EXPERIMENTAL

10mg lenalidomide

Intervention Type: DRUG

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)

Prednisone monotherapy group

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).

Group Type: ACTIVE_COMPARATOR

Prednisone monotherapy

Intervention Type: DRUG

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).

Interventions

5mg 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)

Intervention Type: DRUG

10mg 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)

Intervention Type: DRUG

Prednisone 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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wen Zhang

Vice director of rheumatology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking Union Medical College Hospital, Beijing, Beijing 100050

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Peng linyi

Role: primary

Other Identifiers

I-25PJ0175

Identifier Type: -

Identifier Source: org_study_id