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

Not Applicable

Recruiting

• Conditions: IgG4 Related Disease
• Interventions: Drug: 5mg lenalidomide; Drug: 10mg lenalidomide; Drug: Prednisone monotherapy

• Registration Number: NCT07068165
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-07-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2028-07-20
• Study Completion: 2028-08-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5mg lenalidomide group	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)
10 mg lenalidomide group	10mg lenalidomide	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).
Prednisone monotherapy group	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).

Primary Outcome Measures

Name	Time	Method
Recurrence rate at 52 weeks	"From enrollment to the end of treatment at 52 weeks

Secondary Outcome Measures

Name	Time	Method
IgG4 - RD RI change	At 4, 12, 24, 36, 52 weeks
Treatment response rate	At 4, 12, 24, 36, 52 weeks
Change of IgG4-RD damage index (DI)	At 4, 12, 24, 36, 52 weeks
security	At 4, 12, 24, 36, 52 weeks	Use CTCAE V5.0 to record adverse events
physician's overall assessment of disease activity	At 4, 12, 24, 36, 52 weeks
Changes of serum IgG4 levels	At 4, 12, 24, 36, 52 weeks

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Beijing, Beijing 100050; 🇨🇳 Beijing, China