IgG4 Related DiseasePhase 2NCT07878585
Tripterygium Wilfordii Plus Prednisone for Active IgG4-Related Disease
A Phase 2 study testing Prednisone and tripterygium wilfordii in people with IgG4 Related Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if tripterygium wilfordii added to prednisone can treat active IgG4-related disease (IgG4-RD) in adults 45 to 80 years of age. Women in the study must be postmenopausal. Read more about this study
- Who is it for?
- Ages 45 to 79 years
- Conditions the study is for
- IgG4 Related Disease
- What is being tested?
- Prednisone and tripterygium wilfordii
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Nov 2028
- Phase
- Phase 2
- 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 45 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 45 years and less than 80 years; women must be postmenopausal
- Diagnosis of IgG4-related disease meeting the 2020 Revised Comprehensive Diagnostic Criteria (Japan) or the 2019 ACR/EULAR classification criteria
- Active IgG4-RD, defined as an IgG4-RD Responder Index score of 2 or higher in at least one organ at enrollment
- Treatment-naive or relapsed after discontinuation of prior therapy
Who cannot join
- Organ-threatening or otherwise unsuitable clinical phenotypes as judged by the investigator, including neurologic involvement and IgG4-related sclerosing cholangitis
- Baseline liver-function abnormality (ALT greater than 2 times the upper limit of normal), renal insufficiency (CKD stage 3 or higher, GFR less than 60 mL/min), or heart failure
- Another autoimmune disease as the primary diagnosis
- Malignancy
- Active bacterial, fungal, viral, or mycobacterial infection
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Efficacy and Safety of Tripterygium Wilfordii for IgG4-Related Disease: A Randomized Controlled Trial
The goal of this clinical trial is to learn if tripterygium wilfordii added to prednisone can treat active IgG4-related disease (IgG4-RD) in adults 45 to 80 years of age. Women in the study must be postmenopausal. The main questions it aims to answer are:
- Does adding tripterygium wilfordii to prednisone lower the chance that IgG4-RD comes back at 12 months compared with prednisone alone?
- Does the combination improve remission, disease activity scores, blood tests, quality of life, and remain acceptably safe? Researchers will compare prednisone alone to prednisone plus tripterygium glycoside tablets to see if the combination reduces relapse.
Read more
Participants will:
- Be assigned by chance to prednisone alone or prednisone plus tripterygium glycoside tablets 20 mg three times a day
- Start prednisone at 0.6 to 0.8 mg/kg per day and taper it off within 6 months
- Attend clinic visits at the start of the study and at 1, 3, 6, 9, and 12 months for exams, blood tests, disease scores, and imaging when needed
- Report symptoms and any side effects during the 12-month follow-up
- Conditions
- IgG4 Related Disease
- Being tested
- Prednisone, tripterygium wilfordii
- 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.
PrednisoneDrug
Oral prednisone started at 0.6-0.8 mg/kg/day for 4 weeks, then tapered by 5 mg weekly to 15 mg/day, then by 1.25-2.5 mg weekly, and discontinued within 6 months. Used in both study arms.
tripterygium wilfordiiDrug
Also called Tripterygium glycoside tablets
Tripterygium glycoside tablets 20 mg orally three times daily, given together with the prednisone taper in the experimental arm. This is an approved Chinese herbal extract used off-label for IgG4-related disease in this trial.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone Monotherapy | Active comparator | Oral prednisone started at 0.6-0.8 mg/kg/day for 4 weeks, then tapered by 5 mg weekly to 15 mg/day, then by 1.25-2.5 mg weekly, and discontinued within 6 months. Receives: Drug: Prednisone |
| Prednisone plus Tripterygium wilfordii | Experimental | Oral prednisone started at 0.6-0.8 mg/kg/day for 4 weeks, then tapered by 5 mg weekly to 15 mg/day, then by 1.25-2.5 mg weekly, and discontinued within 6 months, plus tripterygium glycoside tablets 20 mg orally three times daily. Receives: Drug: Prednisone; Drug: tripterygium wilfordii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate
Proportion of participants with IgG4-RD relapse. Relapse is defined as new or worsening disease activity after improvement, based on clinical assessment, laboratory tests, and/or imaging, and reflected by an increase in the IgG4-RD Responder Index that requires treatment intensification.
Measured: 12 months after randomization
Secondary outcomes (8)
Clinical remission rate
Measured: Month 6 and Month 12
Relapse rate
Proportion of participants with IgG4-RD relapse, using the same definition as the primary outcome.
Measured: 6 months after randomization
Change from baseline in IgG4-RD Responder Index (RI)
According to IgG4-RD responder index-2018
Measured: Baseline and Months 1, 3, 6, 9, and 12
Change from baseline in serum laboratory markers
Serum IgG4、Total IgE and IgG
Measured: Baseline and Months 1, 3, 6, 9, and 12
Physician Global Assessment (PGA)
Physician-rated overall disease status. Change from baseline will be compared between groups.
Measured: Baseline and Months 1, 3, 6, 9, and 12
Patient Global Assessment (PGA)
Patient-rated overall disease status. Change from baseline will be compared between groups.
Measured: Baseline and Months 1, 3, 6, 9, and 12
EQ-5D-5L
Health-related quality of life measured by the EQ-5D-5L questionnaire, including the descriptive system and the visual analogue scale.
Measured: Baseline and Months 1, 3, 6, 9, and 12
Incidence of treatment-emergent adverse events
Number and percentage of participants with adverse events and serious adverse events, including laboratory abnormalities related to study treatment (for example, liver enzyme elevation, cytopenia, infection, and glucocorticoid-related events).
Measured: From first dose through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878585
- Sponsor's protocol ID
- TW-IgG4RD-PUMCH
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peng L, Nie Y, Zhou J, Wu L, Chen X, Wang F, Li J, Peng Y, Lu H, Zhao L, Li M, Zhao Y, Zeng X, Fei Y, Zhang W. Withdrawal of immunosuppressants and low-dose steroids in patients with stable IgG4-RD (WInS IgG4-RD): an investigator-initiated, multicentre, open-label, randomised controlled trial. Ann Rheum Dis. 2024 Apr 11;83(5):651-660. doi: 10.1136/ard-2023-224487.
PubMed 38216319
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tripterygium Wilfordii for IgG4-Related Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07878585
- Acronym / sponsor ID
- TW-IgG4RD-PUMCH
- Conditions
- IgG4 Related Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 16 Oct 2026 (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.
The goal of this clinical trial is to learn if tripterygium wilfordii added to prednisone can treat active IgG4-related disease (IgG4-RD) in adults 45 to 80 years of age. Women in the study must be postmenopausal. The main questions it aims to answer are:
- Does adding tripterygium wilfordii to prednisone lower the chance that IgG4-RD comes back at 12 months compared with prednisone alone?
- Does the combination improve remission, disease activity scores, blood tests, quality of life, and remain acceptably safe? Researchers will compare prednisone alone to prednisone plus tripterygium glycoside tablets to see if the combination reduces relapse.
Participants will:
- Be assigned by chance to prednisone alone or prednisone plus tripterygium glycoside tablets 20 mg three times a day
- Start prednisone at 0.6 to 0.8 mg/kg per day and taper it off within 6 months
- Attend clinic visits at the start of the study and at 1, 3, 6, 9, and 12 months for exams, blood tests, disease scores, and imaging when needed
- Report symptoms and any side effects during the 12-month follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone Monotherapy | Active comparator | Drug: PrednisoneOral prednisone started at 0.6-0.8 mg/kg/day for 4 weeks, then tapered by 5 mg weekly to 15 mg/day, then by 1.25-2.5 mg weekly, and discontinued within 6 months. |
| Prednisone plus Tripterygium wilfordii | Experimental | Drug: Prednisone, Drug: tripterygium wilfordiiOral prednisone started at 0.6-0.8 mg/kg/day for 4 weeks, then tapered by 5 mg weekly to 15 mg/day, then by 1.25-2.5 mg weekly, and discontinued within 6 months, plus tripterygium glycoside tablets 20 mg orally three times daily. |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 45 years and less than 80 years; women must be postmenopausal
- Diagnosis of IgG4-related disease meeting the 2020 Revised Comprehensive Diagnostic Criteria (Japan) or the 2019 ACR/EULAR classification criteria
- Active IgG4-RD, defined as an IgG4-RD Responder Index score of 2 or higher in at least one organ at enrollment
- Treatment-naive or relapsed after discontinuation of prior therapy
Key exclusion criteria (5 listed)
- Organ-threatening or otherwise unsuitable clinical phenotypes as judged by the investigator, including neurologic involvement and IgG4-related sclerosing cholangitis
- Baseline liver-function abnormality (ALT greater than 2 times the upper limit of normal), renal insufficiency (CKD stage 3 or higher, GFR less than 60 mL/min), or heart failure
- Another autoimmune disease as the primary diagnosis
- Malignancy
- Active bacterial, fungal, viral, or mycobacterial infection
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 |
|---|---|---|
| PrednisoneOral prednisone started at 0.6-0.8 mg/kg/day for 4 weeks, then tapered by 5 mg weekly to 15 mg/day, then by 1.25-2.5 mg weekly, and discontinued within 6 months. Used in both study arms. | Drug | Prednisone Monotherapy, Prednisone plus Tripterygium wilfordii |
| tripterygium wilfordiiAlso: Tripterygium glycoside tabletsTripterygium glycoside tablets 20 mg orally three times daily, given together with the prednisone taper in the experimental arm. This is an approved Chinese herbal extract used off-label for IgG4-related disease in this trial. | Drug | Prednisone plus Tripterygium wilfordii |
Primary outcome
Relapse rate
Time frame: 12 months after randomization
Proportion of participants with IgG4-RD relapse. Relapse is defined as new or worsening disease activity after improvement, based on clinical assessment, laboratory tests, and/or imaging, and reflected by an increase in the IgG4-RD Responder Index that requires treatment intensification.
8 secondary outcomes
Clinical remission rate
Time frame: Month 6 and Month 12
Relapse rate
Time frame: 6 months after randomization
Change from baseline in IgG4-RD Responder Index (RI)
Time frame: Baseline and Months 1, 3, 6, 9, and 12
Change from baseline in serum laboratory markers
Time frame: Baseline and Months 1, 3, 6, 9, and 12
Physician Global Assessment (PGA)
Time frame: Baseline and Months 1, 3, 6, 9, and 12
Patient Global Assessment (PGA)
Time frame: Baseline and Months 1, 3, 6, 9, and 12
EQ-5D-5L
Time frame: Baseline and Months 1, 3, 6, 9, and 12
Incidence of treatment-emergent adverse events
Time frame: From first dose through Month 12
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 16 Oct 2026.
- Results publication: PubMed 38216319Peng L, Nie Y, Zhou J, Wu L, Chen X, Wang F, Li J, Peng Y, Lu H, Zhao L, Li M, Zhao Y, Zeng X, Fei Y, Zhang W. Withdrawal of immunosuppressants and low-dose steroids in patients with stable IgG4-RD (WInS IgG4-RD): an investigator-initiated, multicentre, open-label, randomised controlled trial. Ann Rheum Dis. 2024 Apr 11;83(5):651-660. doi: 10.1136/ard-2023-224487.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisone and tripterygium wilfordii 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 5 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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 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.
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?
Contact Linyi Peng (+86 15810395901, drpenglinyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07878585, which also lists 1 linked publication.
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 16 Oct 2026.