Trial · NCT05639114
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants on monthly ianalumab achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) | Week 60 | 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 on monthly or quarterly ianalumab with no moderate or severe British Isles Lupus Assessment Group (BILAG) flare | Baseline to Week 60 | Moderate BILAG flare is defined as 2 or more new BILAG-2004 B items compared to the previous visit; severe BILAG flare is defined as (1 or more new BILAG-2004 A items compared to the previous visit) |
| Secondary | Proportion of participants on monthly or quarterly ianalumab maintaining between Week 36 and Week 60 a reduced corticosteroid (CS) dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower | Week 36 to Week 60 | Maintaining reduced CS dose from Week 36 to Week 60 |
| Secondary | Proportion of participants on monthly or quarterly ianalumab achieving BILAG-based Composite Lupus Assessment (BICLA) | Week 60 | BICLA response is defined as: * Reduction of all baseline BILAG-2004 A to B/C/D and baseline B to C/D and no worsening in other organ systems defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening from baseline in SLEDAI-2K defined as an increase from baseline of \> 0 points * No worsening in PhGA defined as an increase of ≥ 0.3 from baseline on a 0 to 3 PhGA visual analog scale |
| Secondary | Proportion of participants on monthly or quarterly ianalumab achieving Lupus Low Disease Activity State (LLDAS) | Week 60 | LLDAS response is defined as: * SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever). * No new lupus disease activity compared with the previous assessment, defined as any new SLEDAI-2K component that was not present at the previous assessment * PhGA (scale 0-3) ≤ 1 * Current predniso(lo)ne (or equivalent) dose ≤ 7.5 mg daily * Well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents |
| Secondary | Time to first occurrence of SRI-4 (participants on ianalumab monthly or quarterly) | Baseline to Week 60 | Time to first occurrence of SRI-4 from baseline to Week 60 |
| Secondary | Proportion of participants on monthly or quarterly ianalumab achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced corticosteroid dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower | Week 36 to Week 60 | Achieving SRI-4 at Week 60 while maintaining between Week 36 and Week 60 a reduced CS dose of predniso(lo)ne ≤ 5 mg/day or ≤ baseline dose, whichever is lower |
| Secondary | Proportion of participants on monthly or quarterly ianalumab achieving SRI-6 | Week 60 | SRI-6 response is defined as: * SLEDAI-2K reduction from baseline of ≥ 6 points * No BILAG-2004 worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in PhGA, defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale |
| Secondary | Proportion of participants on monthly or quarterly ianalumab achieving Short Form 36 (SF-36) Bodily Pain response | Week 60 | Achieving SF-36 Bodily Pain response |
| Secondary | Proportion of participants on quarterly ianalumab achieving SRI-4 | Week 60 | SRI-4 response is defined as: * SLEDAI-2K reduction from baseline of ≥ 4 points * No BILAG-2004 worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline * No worsening in PhGA, defined as an increase of ≥ 0.3 from baseline on a 0 to 3 visual analog scale |
| Secondary | Proportion of participants on monthly or quarterly ianalumab with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline to Week 60 | To evaluate safety and tolerability of ianalumab s.c. monthly or quarterly |
| Secondary | Number of participants with adverse events | Baseline to Week 60 | To evaluate safety and tolerability of ianalumab s.c. monthly or quarterly |
| Secondary | Proportion of participants with anti-ianalumab antibodies in serum (ADA assay) over time | Baseline to Week 164 | Immunogenicity of ianalumab s.c. monthly or quarterly |
| Secondary | Ianalumab concentration in serum during the treatment and follow-up | Baseline to week 164 | Ianalumab concentration in serum |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT05639114/registered