PS-002 for the Treatment of IgA Nephropathy in Adults
NCT07182227 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-03-20
Summary
The purpose of the study is to evaluate safety, tolerability, and preliminary effectiveness following administration of PS-002 in adults with primary Immunoglobulin A (IgA) nephropathy. This will be a first-in-human study and will include participants at high risk of disease progression despite receiving current standard-of-care treatment.
Participants will be monitored for up to one year after receiving PS-002 and invited to take part in a long-term follow-up study (total follow-up: 5 years).
Conditions
- Immunoglobulin A (IgA) Nephropathy
Interventions
- GENETIC
-
PS-002
Adeno-associated viral vector containing the human Complement Factor I (CFI) gene
Sponsors & Collaborators
-
Purespring Therapeutics Limited
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2028-09-30
- Completion
- 2029-09-30
- FDA Drug
- Yes
Countries
- United States
- United Kingdom
Study Locations
More Related Trials
-
Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis
NCT00885547 ·Status: TERMINATED ·Phase: NA
-
Treatment of Deficient Subclass or Anti-polysaccharide Antibody Response
NCT00522821 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 Gangliosidosis
NCT03952637 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction
NCT00547365 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.
NCT02187900 ·Status: UNKNOWN ·Phase: PHASE3
-
A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions
NCT07025577 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath
NCT01879514 ·Status: UNKNOWN ·Phase: NA
-
Study of CM313 in Subject With IgA Nephropathy
NCT06830395 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Gene Therapy for IGHMBP2-Related Diseases
NCT05152823 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE1/PHASE2
-
Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study)
NCT01560052 ·Status: COMPLETED ·Phase: NA
-
A Study of Zigakibart in Adults With IgA Nephropathy
NCT05852938 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
NCT05775042 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
NCT00542997 ·Status: COMPLETED ·Phase: PHASE3
-
Rituximab Treatment of Focal Segmental Glomerulosclerosis
NCT00550342 ·Status: WITHDRAWN ·Phase: PHASE2
-
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
NCT00168025 ·Status: COMPLETED ·Phase: PHASE3
-
Randomized Placebo Controlled Trial of IVIg in Glycine Receptor Antibody Positive Stiff-person Syndrome
NCT03749096 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
NCT05523167 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
NCT06520514 ·Status: COMPLETED ·Phase: PHASE1
-
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
NCT00977977 ·Status: RECRUITING ·Phase: PHASE2
-
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
NCT05248659 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2/PHASE3
-
Treatment of IgA Nephropathy According to Renal Lesions
NCT03188887 ·Status: COMPLETED ·Phase: PHASE3
-
BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
NCT02052219 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
NCT05979441 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE3
-
A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)
NCT05817669 ·Status: COMPLETED ·Phase: PHASE2
-
Rituximab in Treating Patients With Peripheral Neuropathy Caused by Monoclonal Gammopathy of Undetermined Significance
NCT00588822 ·Status: TERMINATED ·Phase: PHASE2