NCT07068165 A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease
| NCT ID | NCT07068165 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | IgG4 Related Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2028-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 198 participants in total. It began in 2025-07-07 with a primary completion date of 2028-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 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； 2. 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； 3. Patients with the clinical subtype of proliferative IgG4-RD； 4. 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: 1. IgG4-RD patients with only fibrotic features; 2. Absolute neutrophil count \<1.5×10\^9 /L or platelet count \<100×10\^9/L; 3. Creatinine clearance less than 60 ml/ min; 4. Liver function Child-Pugh grade B or above; 5. Chronic active infection requiring systemic treatment; 6. Diagnosed with malignant tumor in the past five years; 7. Patients with a history of thrombosis; 8. Using biological agents within six months; 9. Known to be allergic to lenalidomide or thalidomide; 10. Pregnant or lactating women; 11. Patients with any other medical conditions or for specific reasons judged by the investigator to be ineligible to participate in the study.
Frequently Asked Questions
Who can join the NCT07068165 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying IgG4 Related Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07068165 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07068165 currently recruiting?
Yes, NCT07068165 is actively recruiting participants. Visit ClinicalTrials.gov or contact Peking Union Medical College Hospital to inquire about joining.
Where is the NCT07068165 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07068165 clinical trial?
NCT07068165 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 198 participants.