Clinical trials: IgG4-Related Diseases
Immunoglobulin G4 Related Disease
Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants
This is a Phase 2a, multi-center, open-label, two-arm study of approximately 25 patients with active IgG4-related disease (IgG4-RD).
- Trial name
- NCT04520451
- Testing
- rilzabrutinib, Glucocorticoids
- Where
- 9 sites in United States, Canada and 3 more
- Volunteers
- 27 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
Main purpose: To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, IgG4 Related Disease
- Trial name
- NCT06361745
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Where
- China
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Immunoglobulin G4 Related Disease
A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
This is a Phase 3, parallel group, 2-arm, randomized, double blind, placebo-controlled, 52-week treatment study to assess the efficacy and safety of rilzabrutinib as a treatment for adult patients with active IgG4-RD.
- Trial name
- RILIEF (NCT07190196)
- Testing
- Rilzabrutinib, Glucocorticoid
- Where
- 95 sites in United States, Argentina and 17 more
- Volunteers
- 124 people
- Sponsor
- Sanofi
IgG4 Related Disease
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).
- Trial name
- NCT04540497
- Testing
- Inebilizumab
- Where
- 72 sites in United States, Argentina and 19 more
- Volunteers
- 135 people
- Sponsor
- Amgen
IgG4 Related Disease
Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With IgG4-Related Disease
ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Immunoglobulin G4 Related Disease (IgG4-RD)
- Trial name
- NCT07061938
- Testing
- ACE1831, Lymphodepleting chemotherapy
- Where
- 11 sites in United States, China and 1 more
- Volunteers
- 34 people
- Sponsor
- Acepodia Biotech, Inc.
AMG 335 Expanded Access Program for IgG4-Related Disease
Expanded access requests for AMG 335 may be considered for adult patients with a confirmed diagnosis of IgG4-related disease. To request access, use Responsible Party contact information provided in this record.
- Trial name
- NCT06590051
- Testing
- UPLIZNA
- Sponsor
- Amgen
Immunoglobulin G4-related Disease
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD), as well as to assess the safety and tolerability, of inebilizumab in pediatric participants with IgG4-RD.
- Trial name
- NCT07222553
- Testing
- Inebilizumab
- Where
- 14 sites in United States, Brazil and 5 more
- Volunteers
- 15 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06978647
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
IgG4-RD
Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease (RD)
The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity
- Trial name
- NCT02725476
- Testing
- XmAb5871
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Xencor, Inc.
IgG4 Related Disease
A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease
This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)
- Trial name
- INDIGO (NCT05662241)
- Testing
- Obexelimab
- Where
- 65 sites in United States, Argentina and 13 more
- Volunteers
- 194 people
- Sponsor
- Zenas BioPharma (USA), LLC