A Phase 3 interventional study of Lenalidomide and Placebo in Immunoglobulin G4-Related Disease, sponsored by Chinese PLA General Hospital. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Chinese PLA General Hospital · Phase 3, Interventional, and Treatment
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Among 40 studies in Immunoglobulin G4-Related Disease with a site in China — 25 open to participants now, 28 under way, 5 of them phase 3. Immunoglobulin G4-Related Disease · China.
Among the 40 studies in Immunoglobulin G4-Related Disease with a site in China, this one is the 3rd largest by planned enrollment of the 36 interventional ones that give a count, is one of 7 that started in 2026, is one of 4 in phase 3, reaches primary completion later than 25 of the 27 other live ones, and was the 37th registered.
72 studies on the registry are indexed under Immunoglobulin G4-Related Disease; 40 are open to participants now.
Browse Immunoglobulin G4-Related Disease studies →25 of the 40 studies in Immunoglobulin G4-Related Disease with a site in China are open now. Recruiting first, the newest first:
Amgen · Sites in China, United States, Brazil and 5 more countries
Ages 2–18
Acepodia Biotech, Inc. · Sites in China, United States, Japan
Ages 18+
Sanofi · Sites in China, United States, Argentina and 16 more countries
Ages 18+
Chinese PLA General Hospital · Sites in China
Ages 18–75
Peking Union Medical College Hospital · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 28 Immunoglobulin G4-Related Disease studies recruiting now, 12 (43%) set no upper age limit and 13 (46%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 8 · Phase 3 6 · Phase 4 3
First in 2012; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 146 is above the median of 48 across 52 interventional studies indexed under Immunoglobulin G4-Related Disease.
Median enrollment 59 across the 36 interventional studies, 780 across the 4 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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7 of 40 have an industry lead sponsor. The 10 most frequent:
Chinese PLA General Hospital is the lead sponsor of 571 studies on the registry; 207 are open to participants now.
Chinese PLA General Hospital has 3 studies filed under Immunoglobulin G4-Related Disease — fewer than ten, so there is no comparison to draw.
7 of the studies in Immunoglobulin G4-Related Disease with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03023371Peking Union Medical College HospitalNational Registry of IgG4-RD in China | 2026-12 |
| NCT06285279Nanjing University School of MedicineThe BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases | 2026-12-31 |
| NCT06978738Changzhou No.2 People's HospitalUCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases | 2027-05 |
| NCT06978647China Immunotech (Beijing) Biotechnology Co., Ltd.A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases | 2027-05-19 |
| NCT06497387Tongji HospitalSafety and Efficacy of PRG-1801 for Refractory Lupus Nephritis and IgG4-Related Disease | 2027-07 |
Add all 7 to your calendar (.ics) → With an account.
Among the 40 studies in Immunoglobulin G4-Related Disease with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Immunoglobulin G4-related disease (IgG4-RD) is a systemic immune-mediated fibroinflammatory disorder characterized by lymphoplasmacytic infiltration, IgG4-positive plasma cell accumulation, storiform fibrosis, and involvement of multiple organs. Although glucocorticoids remain the standard first-line therapy for induction of remission, a substantial proportion of patients experience disease relapse during glucocorticoid tapering or after treatment discontinuation. In addition, prolonged glucocorticoid exposure is associated with clinically significant adverse effects, including metabolic complications, osteoporosis, cardiovascular risks, and increased susceptibility to infection. Therefore, effective and well-tolerated maintenance therapies are urgently needed to sustain remission and reduce relapse risk in patients with IgG4-RD.
Accumulating evidence indicates that persistent immune dysregulation contributes to disease recurrence in IgG4-RD even after clinical remission has been achieved. Aberrant B-cell activation, expansion of plasmablasts and plasma cells, dysregulated T-cell responses, and remodeling of the immune microenvironment are considered key components underlying disease persistence and relapse. Therapeutic strategies targeting pathogenic immune pathways, particularly those involving B-cell and plasma cell responses, have shown potential clinical benefits, supporting the concept that immune modulation during the remission phase may prevent disease recurrence.
Lenalidomide is an immunomodulatory agent with established clinical activity in plasma cell disorders and emerging applications in immune-mediated diseases. Through binding to cereblon (CRBN), lenalidomide promotes the degradation of specific immune regulatory transcription factors, including IKZF1 and IKZF3, thereby modulating B-cell activation, plasma cell differentiation, inflammatory cytokine production, and T-cell function. Given the central role of B-cell/plasma cell dysregulation in IgG4-RD pathogenesis, these immunomodulatory properties provide a scientific rationale for evaluating lenalidomide as a maintenance therapy in patients with IgG4-RD who have achieved sustained clinical remission.
This is a phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of lenalidomide as maintenance therapy for relapse prevention in patients with IgG4-RD in sustained clinical remission.
Approximately 146 participants will be enrolled. Eligible participants are adults with IgG4-RD who meet the 2019 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria and have achieved sustained disease control following glucocorticoid therapy. Participants must have no documented disease relapse within the preceding year, an IgG4-RD Responder Index (IgG4-RD RI) score of 0, and be receiving a stable low-dose glucocorticoid regimen before randomization.
Participants will be randomly assigned in a 1:1 ratio to receive either lenalidomide 5 mg orally once daily or matching placebo for 52 weeks. During the initial treatment period, all participants will undergo standardized glucocorticoid tapering according to the predefined protocol. The study adopts a double-blind design, with participants, investigators, outcome assessors, and relevant study personnel blinded to treatment allocation.
The primary objective of this study is to determine whether lenalidomide can reduce the risk of IgG4-RD relapse compared with placebo during the maintenance phase. The primary endpoint is the cumulative relapse rate at week 52 after randomization, defined as the proportion of participants experiencing at least one protocol-defined IgG4-RD relapse event.
Secondary objectives include evaluation of the effect of lenalidomide on time to first relapse, maintenance of remission, disease activity changes, quality of life, and safety outcomes. Secondary endpoints include time to first IgG4-RD relapse, changes in IgG4-RD Responder Index scores, health-related quality of life assessments, and the incidence of adverse events, serious adverse events, and treatment discontinuations.
Exploratory objectives include characterization of immunological and biological changes associated with lenalidomide treatment during the remission maintenance phase. Exploratory endpoints include changes from baseline in serum IgG4, IgG, IgE, complement components (C3 and C4), inflammatory markers, peripheral blood immune cell subsets, transcriptomic profiles, and gut microbiota characteristics.
Safety monitoring will focus on known and potential risks associated with lenalidomide treatment, including hematologic toxicity, thromboembolic events, infections, skin reactions, hepatic and renal abnormalities, and reproductive safety risks. Adverse events and serious adverse events will be continuously monitored throughout the study. An independent data monitoring committee will periodically review accumulated safety data to ensure participant safety and evaluate the overall benefit-risk profile of the intervention.
This study aims to determine whether lenalidomide can serve as an effective and safe glucocorticoid-sparing maintenance therapy for patients with IgG4-RD in sustained clinical remission, with the potential to reduce disease recurrence, prolong remission duration, and minimize long-term glucocorticoid exposure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive lenalidomide 5 mg orally once daily for 52 weeks as maintenance therapy. All participants will undergo standardized glucocorticoid tapering according to the study protocol during the initial treatment period. Lenalidomide will be administered in addition to background glucocorticoid management.
Drug: Lenalidomide
Participants will receive matching placebo orally once daily for 52 weeks as maintenance therapy. All participants will undergo standardized glucocorticoid tapering according to the study protocol during the initial treatment period. The placebo will be identical in appearance, packaging, labeling, and administration procedures to lenalidomide.
Drug: Placebo
Lenalidomide 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.
Also known as: Len
Matching 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.
Time frame: 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 frame: From first dose of study intervention to Week 52
Time to first IgG4-related disease relapse
Time from randomization to the first occurrence of protocol-defined IgG4-related disease relapse.
Time frame: From randomization to Week 52
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.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 26, Week 39, and Week 52
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication, including clinical outcomes and safety data, may be shared with qualified researchers upon reasonable request and approval by the study steering committee.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 12 months after publication of the primary results and for 5 years thereafter.
Access criteria: Qualified researchers may request access to de-identified individual participant data and supporting documents. Requests will be reviewed by the study steering committee based on scientific merit, ethical considerations, and compliance with applicable regulations. Approved researchers will be required to complete a data use agreement before access is granted.
Start is estimated for Aug 2026; primary completion for Dec 2030, 52 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lenalidomide
Immunoglobulin G4-Related Disease →
Chinese PLA General Hospital →