Trial · NCT05126277
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
NCT05126277, Phase 3, Active not recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis. Trials, record NCT05126277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05126277
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
- NCT number
- NCT05126277
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 452 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Lupus Nephritis
- Interventions
- ianalumab s.c. q4w, ianalumab s.c. q12w, placebo s.c.
- First posted
- 2021-11-19
- Last updated
- 2026-10-15
- Other registries' IDs
- eudract:2020-005830-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency and percentage of participants achieving stable Complete Renal Response (CRR) | Week 72 | The primary objective is to demonstrate superiority of ianalumab compared to placebo, in achieving stable CRR (defined as estimated glomerular filtration rate (eGFR) ≥90 ml/min/1.73 m2 or no less than 85% of baseline, AND, 24-hour UPCR \<0.5 g/g) at Week 72 in active lupus nephritis (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous) participants on background SoC therapy. |
| Secondary | Time to first occurrence of stable urine protein-to-creatinine ratio (UPCR) <0.5 g/g or ≥50% reduction from baseline | Week 72 | To demonstrate superiority of ianalumab, compared to placebo, in time to first occurrence of stable urine protein-to-creatinine ratio (UPCR) \<0.5 g/g or ≥50% reduction from baseline up to Week 72 |
| Secondary | Percentage of participants achieving stable Overall Renal Response (ORR), defined as achievement as either Complete Renal Response (CRR) or Partial Renal Response (PRR) | Week 48 | To demonstrate superiority of ianalumab, compared to placebo, in achieving stable Overall Renal Response (ORR) at Week 48 |
| Secondary | Incidence of stable Complete Renal Response (CRR) while maintaining daily corticosteroid dose ≤5 mg/day | Week 72 | To demonstrate superiority of ianalumab, compared to placebo, in achieving stable Complete Renal Response (CRR) at Week 72 while maintaining daily corticosteroid dose ≤5 mg/day between Week 24 and Week 72 |
| Secondary | Incidence of renal-related event or death | Week 72 | To demonstrate superiority of ianalumab, compared to placebo, in preventing renal-related event or death through Week 72 |
| Secondary | Change in British Isles Lupus Activity Group (BILAG) score | Week 72 | To demonstrate superiority of ianalumab, compared to placebo in BILAG-2004 at Week 72 |
| Secondary | Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score | Week 72 | To demonstrate superiority of ianalumab, compared to placebo, in FACIT-Fatigue at Week 72 |
| Secondary | Number of participants with treatment-emergent Adverse Events (AEs) | Week 72 | AEs are any untoward sign or symptom that occurs during the study treatment |
| Secondary | Ianalumab concentration in serum | Week 72 | To characterize the pharmacokinetics (PK) of ianalumab mean, median, minimum and maximum concentrations will be provided |
| Secondary | Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time | Week 72 | To evaluate immunogenicity of ianalumab |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05126277
GET https://conductscience.org/api/trials/v1/NCT05126277/registered