FXS6837 for the Treatment of IgAN Patients
NCT07502638 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-03-31
Summary
This is a multicenter, randomized, double-blind, placebo controlled Phase IIb study to explore the efficacy and safety of FXS6837 capsules in IgAN patients. About 60 patients dignosed with primary IgAN will be enrolled and randomized to three cohorts and take different dosage of FXS6837 or placebo capsules orally according to protocol.
Conditions
Interventions
- DRUG
-
FXS6837 Dose 1
FXS6837 taken orally once a day
- DRUG
-
FXS6837 Dose 2
FXS6837 taken orally once a day
- DRUG
-
Placebo Capsule
Placebo taken orally once a day
Sponsors & Collaborators
-
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
lead INDUSTRY
Principal Investigators
-
Jicheng Lv, Doctor · Peking University First Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2027-09-12
- Completion
- 2027-11-14
Countries
- China
Study Locations
More Related Trials
-
A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)
NCT06935357 ·Status: RECRUITING ·Phase: PHASE3
-
Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
NCT06879067 ·Status: COMPLETED ·Phase: PHASE1
-
Efgartigimod for the Treatment of Guillain-Barré Syndrome
NCT06885762 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)
NCT05817669 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Tolerability of GX-P1 in Healthy Male Volunteers
NCT04298749 ·Status: COMPLETED ·Phase: PHASE1
-
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 Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
NCT07284797 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects
NCT02703051 ·Status: COMPLETED ·Phase: PHASE1
-
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis
NCT07079423 ·Status: RECRUITING ·Phase: PHASE2
-
Iguratimod in Systemic Sclerosis
NCT04515706 ·Status: UNKNOWN ·Phase: NA
-
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
-
Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
NCT04818671 ·Status: COMPLETED ·Phase: PHASE3
-
Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.
NCT02187900 ·Status: UNKNOWN ·Phase: PHASE3
-
Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor
NCT03932864 ·Status: COMPLETED ·Phase: PHASE1
-
IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3
NCT03401073 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
NCT06447597 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Seronegative Myasthenia Gravis - Efgartigimod IV
NCT06587867 ·Status: RECRUITING ·Phase: PHASE3
-
A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis
NCT02115997 ·Status: COMPLETED ·Phase: PHASE4
-
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome
NCT04981145 ·Status: RECRUITING ·Phase: PHASE4
-
The Phase I Study of Recombinant Human Nerve Growth Factor Injection
NCT04232332 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
NCT04281472 ·Status: COMPLETED ·Phase: PHASE2
-
To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom
NCT03368274 ·Status: UNKNOWN ·Phase: PHASE4
-
Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod
NCT06860633 ·Status: RECRUITING ·Phase: PHASE4
-
A Prospective Cohort Study of Myasthenia Gravis in China
NCT06006832 ·Status: RECRUITING
-
Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome
NCT05701189 ·Status: WITHDRAWN ·Phase: PHASE2