Comparing low- and higher-dose lenalidomide plus prednisone versus prednisone alone for active proliferative IgG4‑related disease

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

This 52-week randomized trial will test whether adding 5 mg or 10 mg lenalidomide to prednisone helps adults with active proliferative IgG4‑related disease do better than prednisone alone.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: prednisone
• Locations: 1 site (Beijing)
• Trial ID: NCT07068165 on ClinicalTrials.gov

What this trial studies

This is a phase 2/3, 52-week, single-center randomized controlled trial at Peking Union Medical College Hospital comparing three arms: prednisone alone, prednisone plus 5 mg lenalidomide, and prednisone plus 10 mg lenalidomide. Eligible adults (18–75 years) must meet the 2019 ACR/EULAR criteria for IgG4‑RD and have active proliferative disease by IgG4‑RD Response Index thresholds. The trial will monitor clinical response and safety outcomes, including blood counts and renal function, with regular follow-up visits. The goal is to determine whether adding lenalidomide improves disease control or safety compared with standard prednisone therapy.

Who should consider this trial

Good fit: Adults aged 18–75 with active proliferative IgG4‑related disease who meet the 2019 ACR/EULAR criteria, meet the trial's blood-count and renal-function requirements, and agree to reliable contraception are the intended participants.

Not a fit: Patients with primarily fibrotic IgG4‑RD, those with marked neutropenia or thrombocytopenia, or those with significantly reduced kidney function are unlikely to benefit or are excluded from this protocol.

Why it matters

Potential benefit: If successful, adding lenalidomide could improve disease control and reduce relapses or steroid exposure compared with prednisone alone.

How similar studies have performed: This approach is relatively novel for IgG4‑RD: rituximab has established efficacy, but lenalidomide has only limited prior data (case reports or small series) in this disease.

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.

Where this trial is running

Beijing

• Peking Union Medical College Hospital, Beijing, Beijing 100050 — Beijing, China (RECRUITING)

Conditions: IgG4 Related Disease