Trial · NCT03453619
Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
NCT03453619, Phase 2, Completed, Apellis Pharmaceuticals, Inc.; results first posted 2025-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies. Trials, record NCT03453619. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03453619
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
- NCT number
- NCT03453619
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Conditions
- IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, C3 Glomerulonephritis, Dense Deposit Disease
- Interventions
- APL-2
- First posted
- 2018-03-05
- Last updated
- 2025-02-13
- Results first posted
- 2025-02-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Change From Baseline in Proteinuria at Week 48 | Baseline (Day 1) and 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. |
| Primary | Part B: Change From Baseline in Proteinuria at Week 168 | Baseline (Part A, Week 48) and 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. |
| 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 | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 | 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. |
| 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 | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 | 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. |
| Secondary | Parts A and B: Change From Baseline in C3a Concentrations at Week 48 of Part A and Week 168 of Part B | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 | 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. |
| Secondary | Parts A and B: Change From Baseline in Serum Albumin Levels at Week 48 of Part A and Week 168 of Part B | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 | 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. |
| Secondary | Parts A and B: Number of Subjects With Complete Clinical Remission at Week 48 of Part A and Week 168 of Part B | Part A: Week 48; Part B: Week 168 | The complete clinical remission was defined as normalization of proteinuria as defined by \<200 mg/g uPCR. |
| 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 | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Change From Baseline in Proteinuria at Week 48 | Baseline (Day 1) and Week 48 | 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. | ratio | MEAN |
| 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 | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | milligram per deciliter | MEAN |
| 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 | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | units per milliliter | MEAN |
| SECONDARY | Parts A and B: Change From Baseline in C3a Concentrations at Week 48 of Part A and Week 168 of Part B | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | microgram per liter | MEAN |
| SECONDARY | Parts A and B: Change From Baseline in Serum Albumin Levels at Week 48 of Part A and Week 168 of Part B | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | gram per deciliter | MEAN |
| SECONDARY | Parts A and B: Number of Subjects With Complete Clinical Remission at Week 48 of Part A and Week 168 of Part B | Part A: Week 48; Part B: Week 168 | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168 | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and specific timepoints are reported. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Change From Baseline in Proteinuria at Week 168 | Baseline (Part A, Week 48) and Week 168 | The ITT population included all subjects who received at least 1 dose of pegcetacoplan. Only subjects analyzed at baseline and Week 168 are reported. | ratio | MEAN |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Change From Baseline in Proteinuria at Week 48 | Part A: IgAN Subjects | -0.1364 | 95% Confidence Interval -1.0641 to 0.7913 | ratio | |
| Part A: Change From Baseline in Proteinuria at Week 48 | Part A: LN Subjects | 0.3560 | 95% Confidence Interval NA to NA | ratio | |
| Part A: Change From Baseline in Proteinuria at Week 48 | Part A: PMN Subjects | 0.3430 | 95% Confidence Interval NA to NA | ratio | |
| Part A: Change From Baseline in Proteinuria at Week 48 | Part A: C3G Subjects | -2.0347 | 95% Confidence Interval -3.9033 to -0.1662 | ratio | |
| 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 | Part A: IgAN Subjects | 153.17 | 95% Confidence Interval 27.94 to 278.39 | milligram per deciliter | |
| 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 | Part A: PMN Subjects | 324.00 | 95% Confidence Interval NA to NA | milligram per deciliter | |
| 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 | Part A: C3G Subjects | 194.43 | 95% Confidence Interval 109.45 to 279.41 | milligram per deciliter | |
| 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 | Part B: IgAN Subjects | -74.00 | 95% Confidence Interval -506.01 to 358.01 | milligram per deciliter | |
| 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 | Part B: C3G Subjects | -48.50 | 95% Confidence Interval -214.73 to 117.73 | milligram per deciliter | |
| 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 | Part A: IgAN Subjects | -17.3 | 95% Confidence Interval -71.0 to 36.3 | units per milliliter |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Study (Part A) | STARTED | IgAN Subjects | 6 | |
| Core Study (Part A) | STARTED | LN Subjects | 2 | |
| Core Study (Part A) | STARTED | PMN Subjects | 5 | |
| Core Study (Part A) | STARTED | C3G Subjects | 8 | |
| Core Study (Part A) | COMPLETED | IgAN Subjects | 4 | |
| Core Study (Part A) | COMPLETED | LN Subjects | 1 | |
| Core Study (Part A) | COMPLETED | PMN Subjects | 1 | |
| Core Study (Part A) | COMPLETED | C3G Subjects | 7 | |
| Core Study (Part A) | NOT COMPLETED | IgAN Subjects | 2 | |
| Core Study (Part A) | NOT COMPLETED | LN Subjects | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,080
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A: IgAN Subjects | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: LN Subjects | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: PMN Subjects | 2 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: C3G Subjects | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: IgAN Subjects | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: LN Subjects | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: PMN Subjects | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | Part B: C3G Subjects | 0 | 7 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Part A: IgAN Subjects | 0 | 6 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Part A: LN Subjects | 0 | 2 |
1 to 10 of 1,080Source ClinicalTrials.gov
See all 1,080 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: IgAN Subjects | 0 | 6 |
| Total, all-cause mortality | Part A: LN Subjects | 0 | 2 |
| Total, all-cause mortality | Part A: PMN Subjects | 0 | 5 |
| Total, all-cause mortality | Part A: C3G Subjects | 0 | 8 |
| Total, all-cause mortality | Part B: IgAN Subjects | 0 | 4 |
| Total, all-cause mortality | Part B: LN Subjects | 0 | 1 |
| Total, all-cause mortality | Part B: PMN Subjects | 0 | 0 |
| Total, all-cause mortality | Part B: C3G Subjects | 0 | 7 |
| Total, other adverse events | Part A: IgAN Subjects | 5 | 6 |
| Total, other adverse events | Part A: LN Subjects | 1 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37036696 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03453619
GET https://conductscience.org/api/trials/v1/NCT03453619/results?page=2