Immunoglobulin G4-related disease (IgG4-RD) is a chronic immune-mediated disorder characterized by inflammation, fibrosis, and involvement of multiple organs. Although glucocorticoids can effectively induce remission, many patients experience disease relapse after glucocorticoid tapering or discontinuation, and long-term glucocorticoid exposure may cause significant adverse effects. Therefore, new maintenance treatment strategies are needed to reduce relapse risk and minimize glucocorticoid-related toxicity.
This study is designed to evaluate the efficacy and safety of lenalidomide as a maintenance therapy in patients with stable IgG4-RD. This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial.
Eligible participants will be adults with IgG4-RD who meet the 2019 ACR/EULAR IgG4-RD classification criteria and are in a stable disease state. Participants will be randomly assigned in a 1:1 ratio to receive either lenalidomide or matching placebo for 52 weeks. All participants will receive standardized glucocorticoid tapering according to the study protocol.
The primary objective of this study is to determine whether lenalidomide can reduce the risk of IgG4-RD relapse compared with placebo. The primary outcome is the proportion of participants experiencing disease relapse within 52 weeks after randomization.
Secondary objectives include evaluation of time to relapse, maintenance of remission, changes in disease activity, quality of life, and safety outcomes. Exploratory assessments will investigate changes in immunological biomarkers, peripheral blood immune profiles, transcriptomic characteristics, and gut microbiota.
This study aims to provide clinical evidence for a new maintenance treatment approach for patients with IgG4-RD and potentially reduce disease recurrence and glucocorticoid exposure.
Adults aged 18 to 75 years at the time of screening.
Diagnosis of IgG4-related disease according to the 2019 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria.
Patients with IgG4-related disease who have achieved sustained clinical remission following glucocorticoid therapy.
No documented IgG4-related disease relapse within the previous 12 months before screening.
Active IgG4-related disease requiring induction therapy or escalation of immunosuppressive treatment at screening.
Previous treatment with lenalidomide or known hypersensitivity to lenalidomide or related compounds.
Requirement for prohibited concomitant medications during the study period.
Significant uncontrolled infection or active severe infection.
Parallel
Lenalidomide
DrugLenalidomide will be administered orally at a dose of 5 mg once daily for 52 weeks as maintenance therapy in participants with IgG4-related disease in sustained clinical remission. All participants will undergo standardized glucocorticoid tapering according to the study protocol during the initial treatment period.
Placebo
DrugMatching placebo will be administered orally once daily for 52 weeks as maintenance therapy. The placebo will be identical to lenalidomide in appearance, packaging, labeling, and administration procedures. All participants will undergo standardized glucocorticoid tapering according to the study protocol during the initial treatment period.
Cumulative relapse rate of IgG4-related disease at Week 52
The proportion of participants experiencing at least one protocol-defined IgG4-related disease relapse from randomization to Week 52.
Incidence of adverse events and serious adverse events
Incidence of adverse events, serious adverse events, adverse events leading to treatment interruption or discontinuation, and adverse events of special interest during the study period.
Time to first IgG4-related disease relapse
Time from randomization to the first occurrence of protocol-defined IgG4-related disease relapse.
Changes in immunological biomarkers
Changes from baseline in serum IgG4, IgG, IgE, complement components, inflammatory markers, peripheral blood immune cell subsets, transcriptomic profiles, and gut microbiota characteristics.
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Chinese PLA General Hospital
Lead sponsor
Beijing SL Pharmaceutical Co., Ltd.
Collaborator
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