Clinical trials: Complement Mediated Diseases, active
Hereditary Angioedema, HAE
A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema
This is a Phase 1/2, single-arm, open-label, dose-escalation and dose-expansion study of BMN 331 for the treatment of hereditary angioedema (HAE) due to C1 Esterase Inhibitor (C1-INH) protein deficiency.
- Trial name
- HAErmony-1 (NCT05121376)
- Testing
- Dose 1 of BMN 331, Dose 2 of BMN 331, Dose 3 of BMN 331
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 44 people
- Sponsor
- BioMarin Pharmaceutical
Hereditary Angioedema (HAE), Angioedema
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
To assess the efficacy of prophylactic treatment with deucrictibant extended release (XR) tablet versus placebo in preventing angioedema attacks, and to also assess the efficacy of deucrictibant soft capsules as on-demand…
- Conditions
- Hereditary Angioedema (HAE), Angioedema, Bradykinin-mediated Angioedema, C1 Inhibitor Deficiency
- Trial name
- BK-AE-nC1INH (NCT07046806)
- Testing
- Deucrictibant XR tablet, Deucrictibant 20 mg capsule
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Institute for Asthma and Allergy
IgA Nephropathy (IgAN), C3 Glomerulopathy
A Study of SGB-9768 in Patients With Complement-mediated Kidney Diseases
This study looks at how well and safely SGB-9768 works for patients with certain kidney diseases: primary IgA nephropathy, C3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis.
- Conditions
- IgA Nephropathy (IgAN), C3 Glomerulopathy, IC-MPGN
- Trial name
- NCT06786338
- Testing
- SGB-9768
- Where
- 11 sites in China
- Volunteers
- 45 people
- Sponsor
- Suzhou Sanegene Bio Inc.
Glomerulonephritis
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with IgAN and C3G. The study will start with enrolling the IgAN cohort.
- Trial name
- NCT05517980
- Testing
- KP104
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Kira Pharmacenticals (US), LLC.
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose…
- Conditions
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM)
- Trial name
- NCT06371417
- Testing
- RAY121
- Where
- 77 sites in United States, Australia and 18 more
- Volunteers
- 144 people
- Sponsor
- Chugai Pharmaceutical
Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G)
Chinese Adults With Kidney Disease
This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases.
- Conditions
- Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G), IC-MPGN
- Trial name
- NCT07522099
- Testing
- ADX-038, Telitacicept
- Where
- 9 sites in China
- Volunteers
- 30 people
- Sponsor
- ADARx Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria, PNH, Complement-mediated Kidney Disease
A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants
This study is a first-in-human (FIH) trial of CMS-D017 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple…
- Trial name
- NCT07462780
- Testing
- CMS-D017 Capsule
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Shenzhen Kangzhe Biotechnology Co., Ltd.
First in Man Study to Evaluate Initial Safety
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GL-0719 following single intravenous (IV) and subcutaneous injection (SC) doses in…
- Trial name
- NCT05318534
- Testing
- GL-0719
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Gliknik Inc.
C3 Glomerulopathy, Complement-mediated Kidney Disease
CHART-C3G/CLNP023B12011
This is a non-interventional chart abstraction cohort study with longitudinal follow up. Patients with C3G treated with iptacopan will be enrolled and characterized (i.e., systematically describe and summarize) regarding their…
- Conditions
- C3 Glomerulopathy, Complement-mediated Kidney Disease, Proteinuria
- Trial name
- NCT07331259
- Testing
- Iptacopan
- Volunteers
- 83 people
- Sponsor
- Novartis Pharmaceuticals
Hemolytic-Uremic Syndrome, Membranoproliferative Glomerulonephritis
New Analytic Tools for aHUS and C3G Diagnosis
This protocol is part of a larger project, COMPRare (COMPlement-mediated Rare kidney diseases), which has been financed on behalf of the EJP RD (European Joint Programme on Rare Diseases) program of EU and is leaded by a…
- Conditions
- Hemolytic-Uremic Syndrome, Membranoproliferative Glomerulonephritis, Healthy
- Trial name
- COMPRare (NCT05985122)
- Testing
- C3NEF assay
- Where
- Italy
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Primary Graft Dysfunction, Lung Transplantation
This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction
Lung transplant recipient survival lags other solid organ recipients, with the main early cause of death being primary graft dysfunction (PGD).
- Conditions
- Primary Graft Dysfunction, Lung Transplantation, Acute Lung Injury(ALI), Natural Killer Cell Mediated Immunity
- Trial name
- MARAVIROC (NCT06853223)
- Testing
- Maraviroc
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Complement-mediated Renal Diseases
Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease
This is a multicenter, open-label, proof-of-concept, phase Ⅱ adaptive basket clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic profile of LP-005 Injection as add-on therapy to standard treatment in…
- Trial name
- NCT07363265
- Testing
- LP-005 Injection
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Longbio Pharma
IgAN, C3G
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.
- Conditions
- IgAN, C3G, Complement-mediated Kidney Disease, IgA Nephropathy (IgAN)
- Trial name
- NCT06989359
- Testing
- ADX-038 Dose Level 2, ADX-038 Dose Level 1
- Where
- 38 sites in United States, Australia and 6 more
- Volunteers
- 45 people
- Sponsor
- ADARx Pharmaceuticals, Inc.
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing…
- Conditions
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM)
- Trial name
- NCT06723106
- Testing
- RAY121
- Where
- 62 sites in Australia, Austria and 17 more
- Volunteers
- 144 people
- Sponsor
- Chugai Pharmaceutical