Clinical trials: Complement Mediated Diseases
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.
Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD)
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in…
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Trial name
- BIVV009-01 (NCT02502903)
- Testing
- BIV009
- Where
- Austria
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Bioverativ, a Sanofi company
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
Complement Mediated Glomerular Diseases, Hemolytic Anemia
Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects
The study is being conducted to compare the drug-drug interaction of HRS-5965 with clopidogrel and clarithromycin in healthy subjects.
- Trial name
- NCT07040787
- Testing
- HRS-5965 Capsules, Clopidogrel, Clarithromycin
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
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
C3 Glomerulonephritis, Dense Deposit Disease
A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN
The primary objective of this study was to determine whether ACH-0144471 (also known as danicopan and ALXN2040) increases blood C3 complement protein (C3) levels in participants with low C3 levels due to either C3G or IC-MPGN.
- Conditions
- C3 Glomerulonephritis, Dense Deposit Disease, C3 Glomerulopathy, Immune Complex Mediated Membranoproliferative Glomerulonephritis
- Trial name
- NCT03124368
- Testing
- Danicopan
- Where
- 3 sites in Australia, Belgium and 1 more
- Volunteers
- 6 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Previous Diagnosis With a Complement-mediated Disease and/or With Clinical Manifestations Reasonably Associated With Complement Factor I Deficiency
Screening Study to Identify Patients With Complement Factor I Deficiencies
This is screening study to identify patients with Complement Factor I deficiencies. The primary objective is to identify participants with CFI deficiencies and assess the prevalence in the screened population.
- Trial name
- NCT05072912
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Catalyst Biosciences
Complement-mediated Hemolytic Diseases
Effect of Food of NTQ5082 in Healthy Subjects
NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, open label, two sequence, two period, double crossover-design phase 1 clinical trial to evaluate the food effect on PK after a single oral…
- Trial name
- NCT06558656
- Testing
- NTQ5082 capsule
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
Bradykinin-mediated Angioedema, Hereditary Angioedema (HAE)
A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema
This is a phase IV clinical study. The investigators collect patients with a diagnosis of bradykinin induced angioedema. For a specific study period and prospectively arrange, the eligible patients who has an acute attack of…
- Trial name
- NCT07290855
- Testing
- Icatibant Injection (Icanticure®)
- Where
- Taiwan
- Volunteers
- 5 people
- Sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
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
Recurrent Bacterial Infection, Autoimmune Disorder
A Natural History Study to Assess the Clinical Outcomes of Patients With Complement Factor I Deficiency-Mediated Disease
This study will follow participants with a disease which is associated with an absence or deficiency in Complement Factor I (CFI) as confirmed in the CFI-001 screening study.
- Trial name
- NCT05095623
- Testing
- Natural History Observation
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Catalyst Biosciences
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.
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.
Complement Mediated Primary or Secondary Glomerular Diseases
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function.
- Trial name
- NCT06674915
- Testing
- HRS-5965 capsules
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
IgA Nephropathy
Study of ARO-CFB in Adult Healthy Volunteers
The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs). HVs will receive either one or two doses of ARO-CFB or placebo.
- Trial name
- NCT06209177
- Testing
- ARO-CFB
- Where
- New Zealand
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
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
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.
Complement-mediated Disorders
First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects
First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects
- Trial name
- NCT05937581
- Testing
- CSL040
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- CSL Behring
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.
Complement Mediated Diseases
First-In-Human Clinical Study of the C3 Complement Inhibitor AMY- 101 in Healthy Male Volunteers
Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a Single Ascending Dose (SAD) and a Multiple Dose (MD) of the complement inhibitor AMY-101.
- Trial name
- NCT03316521
- Testing
- AMY-101
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Amyndas Pharmaceuticals S.A.