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NCT05746689

Study of Sirolimus in IgG4-related Disease

Not yet recruiting NA Last updated 28 February 2023
What this trial tests

NA trial testing Sirolimus in IgG4-related Disease in 20 participants. Not yet recruiting.

Timeline
1 March 2023
Primary endpoint
31 December 2026
31 December 2028

Quick facts

Lead sponsorPeking University International Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date1 March 2023
Primary completion31 December 2026
Estimated completion31 December 2028

Drugs / interventions tested

Conditions studied

Sponsor

Peking University International Hospital

Who can join

Adults 18 to 80, any sex, with IgG4-related Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

gG4-related disease (IgG4-RD) is a newly recognized systemic autoimmune disease that can involve the pan-creatobiliary tract, retroperitoneum/aorta, head and neck region, and salivary glands, et al. Glucocorticoids are the first-line agents for the treatment of IgG4-RD, however, in order to maintain long-term disease stability and avoid disease relapse, glucocorticoids maintenance therapy should last for a long period, which may induce various glucocorticoid-associated adverse reactions. Sirolimus plays dual roles in inhibiting lymphocyte activation and fibroblast proliferation. It is inferred from its mechanism that sirolimus is a good potential treatment option for IgG4-RD. Therefore, we conducted this single-arm clinical trial on patients with IgG4-RD to determine the efficacy and safety of sirolimus.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current and future advances in practice: IgG4-related disease.
    Wallace ZS, Katz G, Hernandez-Barco YG, Baker MC. · · 2024 · cited 33× · PMID 38601138 · DOI 10.1093/rap/rkae020
  2. IgG4-Related Disease: Emerging Roles of Novel Genetic Variants, Immune Cell Subsets and Therapeutic Targets.
    Tedesco L, Ali SB, Erman B, Baris S, et al · · 2025 · cited 1× · PMID 40785550 · DOI 10.1111/all.16686
  3. Immunocyte lipid metabolic reprogramming: a novel pathway for targeted intervention in autoimmune diseases.
    Cui Y, Feng Z, Zhao Q, Dai H, et al · · 2025 · PMID 41280910 · DOI 10.3389/fimmu.2025.1713148

Verify or expand the search:

Other trials of Sirolimus

Trials testing the same drug.

Other recruiting trials for IgG4-related Disease

Currently open trials in the same condition.

Other Peking University International Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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