Trial · NCT06133972
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
NCT06133972, Phase 3, Recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). Trials, record NCT06133972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06133972
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
- NCT number
- NCT06133972
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 550 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Placebo, Ianalumab
- First posted
- 2023-11-18
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of treatment-emergent Adverse events/Serious Adverse events | through study completion, up to approximately 324 weeks | Assessment of long-term safety and tolerability of ianalumab |
| Secondary | Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response | up to Week 324 | SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in Physician Global Assessment of Disease Activity (PhGA), defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale |
| Secondary | Proportion of participants who achieved Definition of Remission in SLE (DORIS) response | up to Week 324 | DORIS is defined as: * Clinical SLEDAI (cSLEDAI) = 0 (excluding serological items, anti-dsDNA and complement) * Physician global assessment (PhGA, scale 0-3) \< 0.5 * Current CS (predniso(lo)ne or equivalent) dose ≤ 5 mg/day * Patient may be on antimalarials, low dose glucocorticoids and/or stable immune-suppressive treatment including biologics. |
| Secondary | Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index | up to Week 324 | SLICC/ACR Damage Index is a measure of cumulative damage due to SLE |
| Secondary | Average daily dose of corticosteroids administered | up to Week 324 | Evaluating the effect of ianalumab on corticosteroids intake |
| Secondary | Annualized BILAG moderate or severe flare rate | up to Week 324 | Annualized BILAG moderate or severe flare rate where moderate BILAG flare is defined as 2 or more new BILAG-2004 B items, and severe BILAG flare is defined as 1 or more new BILAG-2004 A items, compared to the previous visit |
| Secondary | Ianalumab serum concentrations during treatment and follow-up after last dose | up to Week 324 | To characterize the Pharmacokinetics (PK) of ianalumab |
| Secondary | Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) over time. | up to Week 324 | To characterize the 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/NCT06133972
GET https://conductscience.org/api/trials/v1/NCT06133972/registered