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

NCT07068165 | Recruiting Phase 2

• 1 other identifier: I-25PJ0175
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Recurrence rate at 52 weeks

  "From enrollment to the end of treatment at 52 weeks

Secondary Outcomes (6)

• Treatment response rate

  At 4, 12, 24, 36, 52 weeks

• IgG4 - RD RI change

  At 4, 12, 24, 36, 52 weeks

• Change of IgG4-RD damage index (DI)

  At 4, 12, 24, 36, 52 weeks

• 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

Study Arms (3)

5mg lenalidomide group

EXPERIMENTAL

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)

Drug: 5mg lenalidomide

10 mg lenalidomide group

EXPERIMENTAL

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).

Drug: 10mg lenalidomide

Prednisone monotherapy group

ACTIVE COMPARATOR

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).

Drug: Prednisone monotherapy

Interventions

5mg lenalidomide 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)

5mg lenalidomide group

10mg lenalidomide 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)

10 mg lenalidomide group

Prednisone monotherapy 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).

Prednisone monotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• 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；
• Patients with the clinical subtype of proliferative IgG4-RD；
• Patients who have no plans for pregnancy within the next 18 months and who agree to use reliable contraceptive measures during the study period；

You may not qualify if:

• IgG4-RD patients with only fibrotic features;
• Absolute neutrophil count \<1.5×10\^9 /L or platelet count \<100×10\^9/L;
• Creatinine clearance less than 60 ml/ min;
• Liver function Child-Pugh grade B or above;
• Chronic active infection requiring systemic treatment;
• Diagnosed with malignant tumor in the past five years;
• Patients with a history of thrombosis;
• Using biological agents within six months;
• Known to be allergic to lenalidomide or thalidomide;
• Pregnant or lactating women;
• Patients with any other medical conditions or for specific reasons judged by the investigator to be ineligible to participate in the study.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Beijing, Beijing 100050

Beijing, China

RECRUITING

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of rheumatology department

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): July 20, 2028
• Study Completion (Estimated): August 20, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-04

Locations

CN (1)