IgG4 Related DiseasePhase 2/3IgG4-RDNCT07068165
A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease
A Phase 2/3 study testing 5mg lenalidomide, 10mg lenalidomide and Prednisone monotherapy in people with IgG4 Related Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IgG4 Related Disease
- What is being tested?
- 5mg lenalidomide, 10mg lenalidomide and Prednisone monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2025to 20 Aug 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Beijing, Beijing 100050
Beijing
Peng linyi, 8615810395901, drpenglinyi@163.com
About this study
Official title: A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-RD
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.
- Conditions
- IgG4 Related Disease
- Being tested
- 5mg lenalidomide, 10mg lenalidomide, Prednisone monotherapy
- Medical subject headings
- Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mg lenalidomideDrug
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)
10mg lenalidomideDrug
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)
Prednisone monotherapyDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 5mg lenalidomide group | Experimental | 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) Receives: Drug: 5mg lenalidomide |
| 10 mg lenalidomide group | Experimental | Lenalidomide 10mg/ day combined with prednisone, the initial dose of prednisone was 0.6-0.8mg/kg/ day for 2-4 weeks, then 5mg every 1-2 weeks until withdrawal (within 24 weeks). Receives: Drug: 10mg lenalidomide |
| Prednisone monotherapy group | Active comparator | 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). Receives: Drug: Prednisone monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate at 52 weeks
Measured: "From enrollment to the end of treatment at 52 weeks
Secondary outcomes (6)
Treatment response rate
Measured: At 4, 12, 24, 36, 52 weeks
IgG4 - RD RI change
Measured: At 4, 12, 24, 36, 52 weeks
Change of IgG4-RD damage index (DI)
Measured: At 4, 12, 24, 36, 52 weeks
physician's overall assessment of disease activity
Measured: At 4, 12, 24, 36, 52 weeks
Changes of serum IgG4 levels
Measured: At 4, 12, 24, 36, 52 weeks
security
Use CTCAE V5.0 to record adverse events
Measured: At 4, 12, 24, 36, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start7 Jul 2025
- Primary completion20 Jul 2028 (estimated)
- Study completion20 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG4 Related DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Zhang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068165
- Sponsor's protocol ID
- I-25PJ0175
- Acronym
- IgG4-RD
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-RD
- ClinicalTrials.gov ID
- NCT07068165
- Acronym / sponsor ID
- IgG4-RD / I-25PJ0175
- Conditions
- IgG4 Related Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 20 Jul 2028 (estimated)
- Study completion
- 20 Aug 2028 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5mg lenalidomide group | Experimental | Drug: 5mg lenalidomideLenalidomide 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) |
| 10 mg lenalidomide group | Experimental | Drug: 10mg lenalidomideLenalidomide 10mg/ day combined with prednisone, the initial dose of prednisone was 0.6-0.8mg/kg/ day for 2-4 weeks, then 5mg every 1-2 weeks until withdrawal (within 24 weeks). |
| Prednisone monotherapy group | Active comparator | Drug: Prednisone monotherapyThe 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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；
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5mg lenalidomideLenalidomide 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 | 5mg lenalidomide group |
| 10mg lenalidomideLenalidomide 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 | 10 mg lenalidomide group |
| Prednisone monotherapyThe 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). | Drug | Prednisone monotherapy group |
Primary outcome
Recurrence rate at 52 weeks
Time frame: "From enrollment to the end of treatment at 52 weeks
6 secondary outcomes
Treatment response rate
Time frame: At 4, 12, 24, 36, 52 weeks
IgG4 - RD RI change
Time frame: At 4, 12, 24, 36, 52 weeks
Change of IgG4-RD damage index (DI)
Time frame: At 4, 12, 24, 36, 52 weeks
physician's overall assessment of disease activity
Time frame: At 4, 12, 24, 36, 52 weeks
Changes of serum IgG4 levels
Time frame: At 4, 12, 24, 36, 52 weeks
security
Time frame: At 4, 12, 24, 36, 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peking Union Medical College Hospital, Beijing, Beijing 100050
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 5mg lenalidomide, 10mg lenalidomide and Prednisone monotherapy in people with IgG4 Related Disease, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate at 52 weeks (time frame: "From enrollment to the end of treatment at 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.