Trial · NCT05097989
Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
NCT05097989, Phase 2, Terminated, Alexion Pharmaceuticals, Inc.; results first posted 2025-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN). Trials, record NCT05097989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05097989
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
- NCT number
- NCT05097989
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Lupus Nephritis, Immunoglobulin A Nephropathy, IgAN, LN
- Interventions
- ALXN2050, Placebo
- First posted
- 2021-10-28
- Last updated
- 2025-10-15
- Other registries' IDs
- eudract:2021-001426-22
- Results first posted
- 2025-10-15
- Limitations and caveats
The study intervention dosing and recruitment were paused, consistent with a data monitoring committee recommendation. Given the anticipated length of the dosing interruption that would have impacted data interpretation following dosing re-initiation, the sponsor decided to terminate the study.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | Baseline, Week 26 | Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms. |
| Secondary | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | Baseline, Week 50 | Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms. |
| Secondary | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26 and Week 50 | Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A reduction from baseline indicated an improvement in symptoms. |
| Secondary | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | Changes in kidney function were monitored using measurements of eGFR and calculated based on the Chronic Kidney Disease Epidemiology Collaboration formula. Results are reported in milliliters/minute/1.73 meters squared (mL/min/1.73 m\^2). Estimates of change from baseline are least-square means based on a mixed-effect model for repeated measures model that included change from baseline as the response variable, treatment as independent variable and adjusts for covariates of baseline and the stratification factor at randomization. An increase in eGFR in response to treatment indicated an improvement in symptoms. |
| Secondary | LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50 | Week 26 and Week 50 | Complete renal response was defined as a decrease in urine protein to creatinine ratio (UPCR) to ≤0.5 gram/gram (g/g), an eGFR rate \>60 mL/min/1.73 m\^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal systemic lupus erythematosus (SLE) flare, or suboptimal response. |
| Secondary | LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50 | Week 26 and Week 50 | Partial renal response was defined as a decrease in UPCR ≥50% compared to baseline, an eGFR rate \>60 mL/min/1.73 m\^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response. |
| Secondary | LN Cohort: Time to the First Occurrence of UPCR ≤0.5 g/g as Measured by a Spot Urine Sample | Up to Week 50 | UPCR was assessed using 24-hour urine collections obtained at designated time points. The time to the first occurrence of UPCR ≤0.5 g/g was summarized by spot urine sample analysis. |
| Secondary | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 12, Week 26, And Week 50 | A corticosteroid taper was carried out per protocol at the clinical discretion of the investigator. |
| Secondary | LN Cohort: Percentage of Participants Experiencing a Renal Flare Through Week 50 | Baseline Through Week 50 | Renal flare was determined in the opinion of the investigator and additional protocol-specified criteria. For participants who achieved a complete renal response, a renal flare was the reproducible recurrence of proteinuria ≥1g/g. For all other participants, a renal flare was either of the following: a reproducible increase of serum creatinine \>25% higher than baseline or above the upper limit of normal (plus additional protocol-specified criteria) or a reproducible doubling of the UPCR from a 24-hour urine collection compared with the lowest previous value obtained after the first dose of study intervention. |
| Secondary | LN Cohort: Percentage of Participants Experiencing an Extrarenal SLE Flare Through Week 50 | Baseline Through Week 50 | Extrarenal SLE flare was defined as an increase in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Safety of Estrogens in Lupus Erythematosus National Assessment modification ≥4 points that was not accounted for by proteinuria, hematuria, urinary cellular casts, hypocomplementemia, or an increase in anti-double-stranded DNA antibody level. The SLEDAI-2K is an instrument that was used to assesses the disease activity of extrarenal SLE flare across 18 disease descriptors. Each descriptor carried a weighted value ranging from 1-8, with the reported score calculated as the sum of these descriptors and ranging from 0 to 85. Higher scores represent increased degrees of disease activity. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | Baseline, Week 26 | Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints. | Percentage Change | MEAN |
| SECONDARY | Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | Baseline, Week 50 | Full Analysis Set: all participants who have been randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints. | Percentage Change | MEAN |
| SECONDARY | Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline | Week 26 and Week 50 | Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints. | Percentage of Participants | NUMBER |
| SECONDARY | Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50 | Baseline, Week 26 and Week 50 | Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints. | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50 | Week 26 and Week 50 | Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints. | Percentage of Participants | NUMBER |
| SECONDARY | LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50 | Week 26 and Week 50 | Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints. | Percentage of Participants | NUMBER |
| SECONDARY | LN Cohort: Time to the First Occurrence of UPCR ≤0.5 g/g as Measured by a Spot Urine Sample | Up to Week 50 | Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. | Weeks | MEDIAN |
| SECONDARY | LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50 | Week 12, Week 26, And Week 50 | Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints. | Percentage of Participants | NUMBER |
| SECONDARY | LN Cohort: Percentage of Participants Experiencing a Renal Flare Through Week 50 | Baseline Through Week 50 | Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. | Percentage of Participants | NUMBER |
| SECONDARY | LN Cohort: Percentage of Participants Experiencing an Extrarenal SLE Flare Through Week 50 | Baseline Through Week 50 | Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. | Percentage of Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | IgAN Cohort: ALXN2050 120 mg | -29.3 | 95% Confidence Interval -51.7 to 3.5 | Percentage Change | |
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | IgAN Cohort: ALXN2050 180 mg | -26.2 | 95% Confidence Interval -41.2 to -7.4 | Percentage Change | |
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | IgAN Cohort: Placebo | -10.3 | 95% Confidence Interval -29.1 to 13.4 | Percentage Change | |
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | LN Cohort: ALXN2050 120 mg | -84.0 | 95% Confidence Interval -95.4 to -44.1 | Percentage Change | |
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | LN Cohort: ALXN2050 180 mg | -58.0 | 95% Confidence Interval -75.1 to -29.2 | Percentage Change | |
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26 | LN Cohort: Placebo | -55.4 | 95% Confidence Interval -73.3 to -25.5 | Percentage Change | |
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | IgAN Cohort: ALXN2050 120 mg | -22.0 | 95% Confidence Interval -58.9 to 48.0 | Percentage Change | |
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | IgAN Cohort: ALXN2050 180 mg | -30.2 | 95% Confidence Interval -53.6 to 4.9 | Percentage Change | |
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | IgAN Cohort: Placebo to ALXN2050 120 mg | -45.9 | 95% Confidence Interval -67.5 to -9.9 | Percentage Change | |
| Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50 | IgAN Cohort: Placebo to ALXN2050 180 mg | -14.0 | 95% Confidence Interval -52.2 to 54.6 | Percentage Change |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Evaluation Period (26 Weeks) | STARTED | IgAN Cohort: ALXN2050 120 mg | 9 | |
| Initial Evaluation Period (26 Weeks) | STARTED | IgAN Cohort: ALXN2050 180 mg | 26 | |
| Initial Evaluation Period (26 Weeks) | STARTED | IgAN Cohort: Placebo | 26 | |
| Initial Evaluation Period (26 Weeks) | STARTED | IgAN Cohort: Placebo to ALXN2050 120 mg | 0 | |
| Initial Evaluation Period (26 Weeks) | STARTED | IgAN Cohort: Placebo to ALXN2050 180 mg | 0 | |
| Initial Evaluation Period (26 Weeks) | STARTED | LN Cohort: ALXN2050 120 mg | 6 | |
| Initial Evaluation Period (26 Weeks) | STARTED | LN Cohort: ALXN2050 180 mg | 17 | |
| Initial Evaluation Period (26 Weeks) | STARTED | LN Cohort: Placebo | 16 | |
| Initial Evaluation Period (26 Weeks) | STARTED | LN Cohort: Placebo to Standard-of-care Background Therapy | 0 | |
| Initial Evaluation Period (26 Weeks) | Received at Least 1 Dose of Study Drug | IgAN Cohort: ALXN2050 120 mg | 9 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events1,503
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 | Agranulocytosis | Blood and lymphatic system disorders | IgAN Cohort: ALXN2050 120 mg | 0 | 9 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | IgAN Cohort: ALXN2050 180 mg | 0 | 26 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | IgAN Cohort: Placebo | 0 | 26 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | IgAN Cohort: Placebo to ALXN2050 120 mg | 0 | 10 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | IgAN Cohort: Placebo to ALXN2050 180 mg | 1 | 9 | 1 |
| other | Agranulocytosis | Blood and lymphatic system disorders | LN Cohort: ALXN2050 120 mg | 0 | 6 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | LN Cohort: ALXN2050 180 mg | 0 | 17 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | LN Cohort: Placebo | 0 | 16 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | LN Cohort: Placebo to Standard-of-care Background Therapy | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | IgAN Cohort: ALXN2050 120 mg | 0 | 9 | 0 |
1 to 10 of 1,503Source ClinicalTrials.gov
See all 1,503 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IgAN Cohort: ALXN2050 120 mg | 0 | 9 |
| Total, all-cause mortality | IgAN Cohort: ALXN2050 180 mg | 0 | 26 |
| Total, all-cause mortality | IgAN Cohort: Placebo | 0 | 26 |
| Total, all-cause mortality | IgAN Cohort: Placebo to ALXN2050 120 mg | 0 | 13 |
| Total, all-cause mortality | IgAN Cohort: Placebo to ALXN2050 180 mg | 0 | 13 |
| Total, all-cause mortality | LN Cohort: ALXN2050 120 mg | 0 | 6 |
| Total, all-cause mortality | LN Cohort: ALXN2050 180 mg | 1 | 17 |
| Total, all-cause mortality | LN Cohort: Placebo | 1 | 16 |
| Total, all-cause mortality | LN Cohort: Placebo to Standard-of-care Background Therapy | 0 | 6 |
| Total, other adverse events | IgAN Cohort: ALXN2050 120 mg | 7 | 9 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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