Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APL-2 | Experimental | Open Label, Study Drug, APL-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APL-2 | Drug | APL-2 administered as a daily subcutaneous infusion for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Change From Baseline in Proteinuria at Week 48 | Change from baseline in proteinuria was assessed based on urinary protein-to-creatinine ratio (uPCR). Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. | Baseline (Day 1) and Week 48 |
| Part B: Change From Baseline in Proteinuria at Week 168 | Change from baseline in proteinuria was assessed based on uPCR. Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | Baseline (Part A, Week 48) and Week 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Change From Baseline in Serum Complement 3 (C3) Levels at Week 48 of Part A and Week 168 of Part B | Blood samples were collected to measure serum C3 levels. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. |
Not provided
Inclusion Criteria:
Patients of at least 18 years of age at screening (16 years of age for C3G), able to provide written informed consent, and able to understand and comply with all scheduled procedures and other requirements of the study by the opinion of Principal Investigator (PI)
Patients must have a diagnosis of IgAN, LN, Primary MN, or C3G confirmed by renal biopsy and required measurements performed prior to study participation
Have proteinuria >750 mg/g (calculated by uPCR on 24 hour urine collection) collected during the first screening visit (Visit 3a).
eGFR≥30mL/min/1.73 m2 calculated by CKD-EPI creatinine equation at screening visit 3a and currently not on dialysis
Must have stable or worsening renal disease, on stable and optimized treatment, in the opinion of the PI, for at least 2 months prior to the first dose of APL-2 (Visit 4); treatments may include, but are not limited to, immunosuppressive agents, anti-hypertensives and/or anti-proteinurics.
Willing to receive vaccinations against Neisseria meningitidis at least 2 weeks prior to dosing on Day 1 with a booster on Day 56 (for both vaccinations) and Pneumococcal and Hib vaccines at least 2 weeks prior to dosing on Day 1.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Children's Hospital Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37036696 | Derived | Budge KL, Verlato A, Bin S, Salem FE, Perin L, La Manna G, Zaza G, Fiaccadori E, Cantarelli C, Cravedi P. Decay-Accelerating Factor Restrains Complement Activation and Delays Progression of Murine cBSA-Induced Membranous Nephropathy. Kidney360. 2023 Jun 1;4(6):e769-e776. doi: 10.34067/KID.0000000000000122. Epub 2023 Apr 8. |
Not provided
Not provided
The study consisted of 2 parts: Part A (core study phase; 48 weeks) and Part B (long-term extension phase; until pegcetacoplan was commercially available for the disease under treatment). Subjects were screened within 4 weeks prior to the start of dosing on Day 1. A total of 21 subjects were enrolled in this study.
This prospective Phase 2, open-label study was conducted in subjects clinically diagnosed with immunoglobulin A nephropathy (IgAN), lupus nephritis (LN), primary membranous nephropathy (PMN), or C3 glomerulopathy (C3G) between 26 February 2018 and 25 August 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IgAN Subjects | Subjects diagnosed with IgAN received pegcetacoplan 360 milligram (mg) subcutaneous (SC) infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Study (Part A) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2022 | Dec 10, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 |
| Parts A and B: Change From Baseline in Alternative Pathway Hemolytic Assay (AH50) Activity at Week 48 of Part A and Week 168 of Part B | Blood samples were collected to measure AH50 activity. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 |
| Parts A and B: Change From Baseline in C3a Concentrations at Week 48 of Part A and Week 168 of Part B | Blood samples were collected to measure C3a concentrations. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 |
| Parts A and B: Change From Baseline in Serum Albumin Levels at Week 48 of Part A and Week 168 of Part B | Blood samples were collected to measure serum albumin levels. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 |
| Parts A and B: Number of Subjects With Complete Clinical Remission at Week 48 of Part A and Week 168 of Part B | The complete clinical remission was defined as normalization of proteinuria as defined by <200 mg/g uPCR. | Part A: Week 48; Part B: Week 168 |
| Parts A and B: Number of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 48 of Part A and Week 168 of Part B | The eGFR stabilization or improvement was defined as an eGFR value that was no more than a 25% decrease relative to baseline. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| HealthONE Physician Care, Rocky Mountain Hospital for Children | Denver | Colorado | 80205 | United States |
| Washington Nephrology Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Horizon Research Group | Coral Gables | Florida | 33134 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| American Research LLC | Jeffersonville | Indiana | 47130 | United States |
| Northwest Louisiana Nephrology LLC | Shreveport | Louisiana | 71101 | United States |
| Washington Nephrology Associates | Takoma Park | Maryland | 20912 | United States |
| Clinical Research Consultants | Kansas City | Missouri | 64111 | United States |
| Davita Clinical Research | The Bronx | New York | 10461 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Southeastern Nephrology Associates | Wilmington | North Carolina | 28401 | United States |
| University Clinical Health | Memphis | Tennessee | 38103 | United States |
| Washington Nephrology Associates | Alexandria | Virginia | 22304 | United States |
| Davita Clinical Research | Chesapeake | Virginia | 23320 | United States |
| Milwaukee Nephrologists | Wauwatosa | Wisconsin | 53226 | United States |
| FG001 | LN Subjects | Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| FG002 | PMN Subjects | Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| FG003 | C3G Subjects | Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| COMPLETED | Completed Part A. |
|
| NOT COMPLETED |
|
|
| Long-Term Extension (Part B) |
|
|
The Safety population included all subjects who received at least 1 dose of pegcetacoplan.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IgAN Subjects | Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| BG001 | LN Subjects | Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| BG002 | PMN Subjects | Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| BG003 | C3G Subjects | Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A and eligible subjects entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A: Change From Baseline in Proteinuria at Week 48 | Change from baseline in proteinuria was assessed based on urinary protein-to-creatinine ratio (uPCR). Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. | The intent-to-treat (ITT) population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and Week 48 are reported. | Posted | Mean | 95% Confidence Interval | ratio | Baseline (Day 1) and Week 48 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Parts A and B: Change From Baseline in Serum Complement 3 (C3) Levels at Week 48 of Part A and Week 168 of Part B | Blood samples were collected to measure serum C3 levels. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | Posted | Mean | 95% Confidence Interval | milligram per deciliter | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Parts A and B: Change From Baseline in Alternative Pathway Hemolytic Assay (AH50) Activity at Week 48 of Part A and Week 168 of Part B | Blood samples were collected to measure AH50 activity. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | Posted | Mean | 95% Confidence Interval | units per milliliter | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Parts A and B: Change From Baseline in C3a Concentrations at Week 48 of Part A and Week 168 of Part B | Blood samples were collected to measure C3a concentrations. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | Posted | Mean | 95% Confidence Interval | microgram per liter | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Parts A and B: Change From Baseline in Serum Albumin Levels at Week 48 of Part A and Week 168 of Part B | Blood samples were collected to measure serum albumin levels. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | Posted | Mean | 95% Confidence Interval | gram per deciliter | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Parts A and B: Number of Subjects With Complete Clinical Remission at Week 48 of Part A and Week 168 of Part B | The complete clinical remission was defined as normalization of proteinuria as defined by <200 mg/g uPCR. | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | Posted | Count of Participants | Participants | Part A: Week 48; Part B: Week 168 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Parts A and B: Number of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 48 of Part A and Week 168 of Part B | The eGFR stabilization or improvement was defined as an eGFR value that was no more than a 25% decrease relative to baseline. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | Posted | Count of Participants | Participants | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Part B: Change From Baseline in Proteinuria at Week 168 | Change from baseline in proteinuria was assessed based on uPCR. Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B. | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and Week 168 are reported. | Posted | Mean | 95% Confidence Interval | ratio | Baseline (Part A, Week 48) and Week 168 |
|
TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.
The Safety population included all subjects who received at least 1 dose of pegcetacoplan. MedDRA version for Part A was 23.0 and Part B was 26.0.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: IgAN Subjects | Subjects diagnosed with IgAN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG001 | Part A: LN Subjects | Subjects diagnosed with LN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Part A: PMN Subjects | Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. | 0 | 5 | 4 | 5 | 5 | 5 |
| EG003 | Part A: C3G Subjects | Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG004 | Part B: IgAN Subjects | Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. | 0 | 4 | 1 | 4 | 4 | 4 |
| EG005 | Part B: LN Subjects | Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. | 0 | 1 | 1 | 1 | 1 | 1 |
| EG006 | Part B: PMN Subjects | Eligible subjects diagnosed with PMN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG007 | Part B: C3G Subjects | Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. | 0 | 7 | 1 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| End-stage renal disease | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac flutter | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctival oedema | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injury associated with device | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Acoustic shock | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skin procedural complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Cystatin C increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperphagia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic kidney disease-mineral and bone disorder | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Persistent depressive disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vaginal odour | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acne cystic | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fracture treatment | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Polypectomy | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Apellis Clinical Trial Information Line | Apellis Pharmaceuticals, Inc | 1-833-284-6361 | clinicaltrials@apellis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2023 | Dec 10, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D008181 | Lupus Nephritis |
| D015433 | Glomerulonephritis, Membranous |
| D015432 | Glomerulonephritis, Membranoproliferative |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Lost to Follow-up |
|
| Non-compliance with study drug |
|
| Physician Decision |
|
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Part A: PMN Subjects |
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG003 | Part A: C3G Subjects | Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG004 | Part B: IgAN Subjects | Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG005 | Part B: LN Subjects | Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG006 | Part B: C3G Subjects | Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
|
|
| OG002 |
| Part A: PMN Subjects |
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG003 | Part A: C3G Subjects | Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG004 | Part B: IgAN Subjects | Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG005 | Part B: LN Subjects | Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG006 | Part B: C3G Subjects | Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
|
|
| Part A: PMN Subjects |
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG003 | Part A: C3G Subjects | Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG004 | Part B: IgAN Subjects | Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG005 | Part B: LN Subjects | Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG006 | Part B: C3G Subjects | Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
|
|
| Part A: PMN Subjects |
Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG003 | Part A: C3G Subjects | Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG004 | Part B: IgAN Subjects | Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG005 | Part B: LN Subjects | Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG006 | Part B: C3G Subjects | Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
|
|
| OG003 | Part A: C3G Subjects | Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG004 | Part B: IgAN Subjects | Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG005 | Part B: LN Subjects | Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG006 | Part B: C3G Subjects | Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
|
|
| OG002 | Part A: PMN Subjects | Subjects diagnosed with PMN received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG003 | Part A: C3G Subjects | Subjects diagnosed with C3G received pegcetacoplan 360 mg SC infusion once daily up to 48 weeks in Part A. Subjects were able to switch over to twice-weekly dosing with pegcetacoplan 1080 mg, as early as Week 24, but no later than the entrance into Part B. |
| OG004 | Part B: IgAN Subjects | Eligible subjects diagnosed with IgAN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG005 | Part B: LN Subjects | Eligible subjects diagnosed with LN entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
| OG006 | Part B: C3G Subjects | Eligible subjects diagnosed with C3G entered Part B to continue to receive pegcetacoplan 360 mg SC infusion until it was commercially available for the disease under treatment. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|