Trial · NCT04181762
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
NCT04181762, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2024-10-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis. Trials, record NCT04181762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04181762
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
- NCT number
- NCT04181762
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 275 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Lupus Nephritis
- Interventions
- secukinumab, Placebo
- First posted
- 2019-11-29
- Last updated
- 2025-05-16
- Other registries' IDs
- eudract:2019-003211-57
- Results first posted
- 2024-10-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52 | Baseline, Week 52 | Complete Renal Response (CRR) is a composite endpoint defined as: * Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of core Baseline values and * 24-hour Urine-to-Protein Creatinine Ratio (UPCR) =\< 0.5mg/mg * No treatment discontinuation before Week 52 * The subject did not receive more than 10 mg/day prednisone or equivalent for \>= 3 consecutive days or for \>= 7 days in total during Week 44 through Week 52. Non-responder imputation (NRI) was used for participants who did not have the required data to compute responses at Week 52 or who had discontinued study treatment before Week 52. A logistic regression model was used for the analysis of this endpoint. |
| Secondary | Change From Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR) | Baseline, Week 52 | Urine Protein-to-Creatinine Ratio (UPCR) was determined by a central laboratory by dividing the protein concentration by the creatinine concentration as measured in the urine collected (24-hour urine collection sample). |
| Secondary | Percentage of Participants Achieving Partial Renal Response (PRR) at Week 52 | Baseline, Week 52 | Partial Renal Response (PRR) is a composite endpoint defined as: * \>= 50% reduction in 24-hour Urine-to-Protein Creatinine Ratio (UPCR) to sub-nephrotic levels (=\< 3 mg/mg) and * Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of Baseline |
| Secondary | Average Daily Dose of Oral Corticosteroids | Week 16 to Week 52 | Average daily dose of oral corticosteroids doses was used to assess efficacy of secukinumab compared to placebo in the averaged daily dose of oral corticosteroids administered between Week 16 and Week 52. |
| Secondary | Percentage of Participants Achieving Partial Renal Response (PRR) at Week 24 | Baseline, Week 24 | Partial Renal Response (PRR) is a composite endpoint defined as: * \>= 50% reduction in 24-hour Urine-to-Protein Creatinine Ratio (UPCR) to sub-nephrotic levels (=\< 3 mg/mg) and * Estimated Glomerular Filtration Rate (eGFR) \>= 60 mL/min/1.73 m\^2 or no less than 85% of Baseline |
| Secondary | Incidence Rate of Participants Achieving Complete Renal Response (CRR) up to Week 52 | Baseline to Week 52 | Time to achieve Complete Renal Response (CRR) up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve CRR were censored at the date of their last non-missing CRR result (including participants who completed week 52 without achieving CRR). * Subjects at risk = Subjects who did not achieve CRR and were not censored before or at the start of the specified interval. Participants had an event when achieving CRR. * Incidence rate (%) = (number of subjects with event/number of subjects at risk) x 100. |
| Secondary | Incidence Rate of Participants Achieving Partial Renal Response (PRR) up to Week 52 | Baseline to Week 52 | Time to achieve Partial Renal Response (PRR) up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve PRR were censored at the date of their last non-missing PRR result (including participants who completed week 52 without achieving PRR). Participants had event when achieving PRR. * Subjects at risk = Subjects who did not achieve PRR and were not censored before or at the start of the specified interval. * Incidence rate (%) = (number of subjects with event/ number of subjects at risk) x 100. |
| Secondary | Time to Achieve First Morning Void Urine Protein-to-Creatinine Ratio (UPCR) <= 0.5 mg/mg up to Week 52 | Baseline to Week 52 | Time to achieve first morning void Urine Protein-to-Creatinine Ratio (UPCR) \<= 0.5 mg/mg up to week 52 was evaluated by 4-week interval by using Kaplan-Meier estimates. Participants who did not achieve UCPR were censored at the date of their last non-missing UCPR result (including participants who completed week 52 without achieving UCPR). Participants had event when achieving UCPR. * Subjects at risk = Subjects who did not achieve UCPR and were not censored before or at the start of the specified interval. * Incidence rate (%) = (number of subjects with event/ number of subjects at risk) x 100. |
| Secondary | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Mean Change From Baseline up to Week 52 | Baseline, Week 12, Week 24, Week 36, Week 52 | The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past week. The purpose of the FACIT-Fatigue in this study was to assess the impact of fatigue on subjects with lupus nephritis (LN). The level of fatigue was measured on a 5-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much) based on their experience of fatigue during the past 2 weeks. The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. FACIT-Fatigue scale score range from 0 to 52, where higher scores represent less fatigue. |
| Secondary | Short Form Health Survey (SF-36) Version 2 (Acute Form) Mean Change From Baseline in Physical Component Score (PCS) up to Week 52 | Baseline, Week 12, Week 24, Week 36, Week 52 | The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). In this trial, SF-36-PCS responder (improvement of \>= 2.5 points) were evaluated. Responses to items allow for direct calculation of scale scores, while the physical component summary (PCS) scores are computed from weighted scale scores. For all scales and summary measures, higher scores indicate better health outcomes (PCS scores range 0 to 100). |
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 | Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52 | Baseline, Week 52 | Full Analysis Set 2. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR) | Baseline, Week 52 | Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included. | mg/mg | MEAN |
| SECONDARY | Percentage of Participants Achieving Partial Renal Response (PRR) at Week 52 | Baseline, Week 52 | Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included. | Percentage of participants | NUMBER |
| SECONDARY | Average Daily Dose of Oral Corticosteroids | Week 16 to Week 52 | Full Analysis Set | mg/day | MEAN |
| SECONDARY | Percentage of Participants Achieving Partial Renal Response (PRR) at Week 24 | Baseline, Week 24 | Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included. | Percentage of participants | NUMBER |
| SECONDARY | Incidence Rate of Participants Achieving Complete Renal Response (CRR) up to Week 52 | Baseline to Week 52 | Participants in the Full Analysis Set with an available value for the outcome measure. Day 1 = Date of randomization. | Percentage of participants | NUMBER |
| SECONDARY | Incidence Rate of Participants Achieving Partial Renal Response (PRR) up to Week 52 | Baseline to Week 52 | Participants in the Full Analysis Set with an available value for the outcome measure. Day 1 = Date of randomization. | Percentage of participants | NUMBER |
| SECONDARY | Time to Achieve First Morning Void Urine Protein-to-Creatinine Ratio (UPCR) <= 0.5 mg/mg up to Week 52 | Baseline to Week 52 | Participants in the Full Analysis Set with an available value for the outcome measure. Day 1 = Date of randomization. | Percentage of participants | NUMBER |
| SECONDARY | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Mean Change From Baseline up to Week 52 | Baseline, Week 12, Week 24, Week 36, Week 52 | Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included. | Unit on a scale | MEAN |
| SECONDARY | Short Form Health Survey (SF-36) Version 2 (Acute Form) Mean Change From Baseline in Physical Component Score (PCS) up to Week 52 | Baseline, Week 12, Week 24, Week 36, Week 52 | Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included. | Unit on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52 | Secukinumab 300 mg | 25.9 | 95% Confidence Interval 16.8 to 34.9 | Percentage of participants | |
| Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52 | Placebo | 38.6 | 95% Confidence Interval 28.5 to 48.7 | Percentage of participants | |
| Change From Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR) | Secukinumab 300 mg | -2.204 | Standard Deviation 3.5162 | mg/mg | |
| Change From Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR) | Placebo | -2.741 | Standard Deviation 5.9448 | mg/mg | |
| Percentage of Participants Achieving Partial Renal Response (PRR) at Week 52 | Secukinumab 300 mg | 56.2 | 95% Confidence Interval 44.1 to 67.8 | Percentage of participants | |
| Percentage of Participants Achieving Partial Renal Response (PRR) at Week 52 | Placebo | 63.9 | 95% Confidence Interval 51.7 to 74.9 | Percentage of participants | |
| Average Daily Dose of Oral Corticosteroids | Secukinumab 300 mg | 8.1243 | Standard Deviation 6.38329 | mg/day | |
| Average Daily Dose of Oral Corticosteroids | Placebo | 7.4791 | Standard Deviation 5.61958 | mg/day | |
| Percentage of Participants Achieving Partial Renal Response (PRR) at Week 24 | Secukinumab 300 mg | 52.8 | 95% Confidence Interval 42.9 to 62.5 | Percentage of participants | |
| Percentage of Participants Achieving Partial Renal Response (PRR) at Week 24 | Placebo | 43.6 | 95% Confidence Interval 34.2 to 53.4 | Percentage of participants |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Secukinumab 300 mg | 137 | |
| Overall Study | STARTED | Placebo | 138 | |
| Overall Study | Full Analysis Set 2 | Secukinumab 300 mg | 91 | |
| Overall Study | Full Analysis Set 2 | Placebo | 91 | |
| Overall Study | Pharmacokinetic Set | Secukinumab 300 mg | 136 | |
| Overall Study | Pharmacokinetic Set | Placebo | 0 | |
| Overall Study | COMPLETED | Secukinumab 300 mg | 23 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | NOT COMPLETED | Secukinumab 300 mg | 114 | |
| Overall Study | NOT COMPLETED | Placebo | 115 |
Source ClinicalTrials.gov
Adverse events300
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 | Secukinumab 300 mg | 12 | 137 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 13 | 138 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Secukinumab 300 mg | 3 | 137 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo | 4 | 138 | |
| other | Leukopenia | Blood and lymphatic system disorders | Secukinumab 300 mg | 6 | 137 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 10 | 138 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Secukinumab 300 mg | 3 | 137 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo | 1 | 138 | |
| other | Neutropenia | Blood and lymphatic system disorders | Secukinumab 300 mg | 3 | 137 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 3 | 138 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Secukinumab 300 mg | 1 | 137 |
| Total, all-cause mortality | Placebo | 1 | 138 |
| Total, other adverse events | Secukinumab 300 mg | 111 | 137 |
| Total, other adverse events | Placebo | 116 | 138 |
| Total, serious adverse events | Secukinumab 300 mg | 30 | 137 |
| Total, serious adverse events | Placebo | 39 | 138 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Secukinumab 300 mg vs Placebo: deaths from any cause | Trial comparisons |
| Secukinumab 300 mg vs Placebo: serious adverse events | Trial comparisons |
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/NCT04181762
GET https://conductscience.org/api/trials/v1/NCT04181762/results?page=2