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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

July 7, 2025

Primary Completion Date

July 20, 2028

Study Completion Date

August 20, 2028

Conditions
IgG4 Related Disease
Interventions
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).

Trial Locations (1)

Unknown

RECRUITING

Peking Union Medical College Hospital, Beijing, Beijing 100050, Beijing

All Listed Sponsors
lead

Peking Union Medical College Hospital

OTHER

NCT07068165 - A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease | Biotech Hunter | Biotech Hunter