Not yet recruitingNCT07878585Updated Oct 16, 2026

Tripterygium Wilfordii Plus Prednisone for Active IgG4-Related Disease

A Phase 2 interventional study of Prednisone and tripterygium wilfordii in IgG4 Related Disease, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to participants aged 45 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment

Updated Oct 16, 2026Newly registeredGo to Updates ↓

Phase: Phase 2
Study type: Interventional
Enrollment: 74
Allocation: Randomized
Ages: 45 Years to 79 Years
Sex: All

Study 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. 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

Conditions studied

IgG4 Related Disease

Browse trials for

Immunoglobulin G4-Related Disease 69

In context

Immunoglobulin G4-Related Disease

69 studies on the registry are indexed under Immunoglobulin G4-Related Disease; 37 are open to participants now.

This study's planned enrollment of 74 is above the median of 48 across 50 interventional studies indexed under Immunoglobulin G4-Related Disease.

Browse Immunoglobulin G4-Related Disease studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Peking Union Medical College Hospital studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 79 Years
Sexes eligible: All
Accepts healthy volunteers: No

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 74 participants (estimated)

Study arms

Active comparator
Prednisone Monotherapy
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.
Drug: Prednisone
Experimental
Prednisone plus Tripterygium wilfordii
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.
Drug: Prednisone · Drug: tripterygium wilfordii

Interventions

DrugPrednisone
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.
Drugtripterygium wilfordii
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.
Also known as: Tripterygium glycoside tablets

What researchers measure

Primary outcomes

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.
Time frame: 12 months after randomization

Secondary outcomes

Clinical remission rate
Time frame: Month 6 and Month 12
Relapse rate
Proportion of participants with IgG4-RD relapse, using the same definition as the primary outcome.
Time frame: 6 months after randomization
Change from baseline in IgG4-RD Responder Index (RI)
According to IgG4-RD responder index-2018
Time frame: Baseline and Months 1, 3, 6, 9, and 12
Change from baseline in serum laboratory markers
Serum IgG4、Total IgE and IgG
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: From first dose through Month 12

Study locations

1 site

Peking Union Medical College Hospital
Beijing, Beijing Municipality 100730, China

References and documents

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 ↗

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 17, 2026
First posted: Oct 16, 2026
StartEst.: Sep 2026
Primary completionEst.: Sep 2028
CompletionEst.: Nov 2028
Last update: Oct 16, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 16, 2026

Show all 1 update

Oct 16, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07878585
Lead sponsor: Peking Union Medical College Hospital
Responsible party: Sponsor
First posted: Oct 16, 2026
Start date: Sep 2026 (estimated)
Primary completion: Sep 2028 (estimated)
Completion: Nov 2028 (estimated)
Last update: Oct 16, 2026

Study contacts

Linyi Peng

Contact

drpenglinyi@163.com

+86 15810395901

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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