ClinicalTrials.gov record 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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized Phase 2/3 trial compares two doses of lenalidomide plus prednisone with prednisone alone in people with active, proliferative IgG4‑related disease. Participants receive lenalidomide (5 mg or 10 mg daily) together with a prednisone taper, or prednisone alone, and are followed for 52 weeks. The study measures recurrence at 52 weeks and other disease activity and safety outcomes.
What it is studying. The study compares outcomes when adding lenalidomide (5 mg or 10 mg daily) to a standard prednisone taper versus prednisone alone, measuring recurrence, treatment response, disease activity scores, organ damage index, serum IgG4, and safety over 52 weeks.
What the researchers hope to learn. To compare recurrence rate at 52 weeks between the three treatment groups; to measure treatment response rates and changes in IgG4‑RD Response Index (RI) and damage index (DI); to record physician assessments and changes in serum IgG4; and to collect safety data using CTCAE v5.0.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- 5mg lenalidomide
- 10mg lenalidomide
- Prednisone monotherapy
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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；
- 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；
- Patients with the clinical subtype of proliferative IgG4-RD；
- 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
- IgG4-RD patients with only fibrotic features;
- Absolute neutrophil count <1.5×10\^9 /L or platelet count <100×10\^9/L;
- Creatinine clearance less than 60 ml/ min;
- Liver function Child-Pugh grade B or above;
- Chronic active infection requiring systemic treatment;
- Diagnosed with malignant tumor in the past five years;
- Patients with a history of thrombosis;
- Using biological agents within six months;
- Known to be allergic to lenalidomide or thalidomide;
- Pregnant or lactating women;
- Patients with any other medical conditions or for specific reasons judged by the investigator to be ineligible to participate in the study.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are randomly assigned to one of three treatments: lenalidomide 5 mg/day plus prednisone, lenalidomide 10 mg/day plus prednisone, or prednisone alone. Prednisone is given at 0.6–0.8 mg/kg/day for 2–4 weeks, then tapered by 5 mg every 1–2 weeks until stopped (within 24 weeks); lenalidomide is taken daily at the assigned dose. Participants are followed for 52 weeks with assessments at about weeks 4, 12, 24, 36 and 52 to measure response, disease activity, damage index, serum IgG4 levels, and safety; adverse events are recorded using CTCAE v5.0. Participation includes safety assessments (for example laboratory checks and adverse-event monitoring using CTCAE v5.0) and agreement to the contraception requirement described above.
How the study is structured. Randomized, open-label, three-arm trial (parallel groups), Phase 2/3. Groups: lenalidomide 5 mg/day + prednisone taper; lenalidomide 10 mg/day + prednisone taper; or prednisone alone. Prednisone starts at 0.6–0.8 mg/kg/day for 2–4 weeks then is reduced by 5 mg every 1–2 weeks with withdrawal planned within 24 weeks. Participants are followed to 52 weeks; masking: none.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on IgG4-related disease
Important dates
- Study start
- Jul 7, 2025
- Primary completion
- Jul 20, 2028 (estimated)
- Study completion
- Aug 20, 2028 (estimated)
- Target enrollment
- 198 participants (estimated)
- Last updated on registry
- Dec 30, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Peking Union Medical College Hospital
- Principal investigator
- Wen Zhang, Vice director of rheumatology department
Peking Union Medical College Hospital
Participating sites (1)
- Peking Union Medical College Hospital, Beijing, Beijing 100050Recruiting
Beijing · China
- Peng linyi · 8615810395901 · drpenglinyi@163.com
Terms used on this page · explanations by MedicalUpdates.ai
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- prednisone
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- relapse
- A condition that improved with treatment and has since returned or worsened.
- Absolute neutrophil count
- The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
- Creatinine clearance
- A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials