NCT07068165

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

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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)
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)
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).

Timeline

• Start date: 2025-07-07
• Primary completion: 2028-07-20
• Completion: 2028-08-20
• First posted: 2025-07-16
• Last updated: 2025-12-30

Locations

1 site across 1 country: China