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Showing 4 results for “Phase II” published 2023.

July 2023

Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis

Arthritis Care Res (Hoboken). 2023 Jul;75(7):1399–1408 DOI: 10.1002/acr.25007

Pooled analysis of data from the AURA-LV phase 2 and AURORA 1 phase 3 trials of voclosporin in patients with active LN demonstrated that significantly more patients achieved a complete renal response at 1 year in the voclosporin than the control group (p<0.0001), with no observation of new safety signals.

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June 2023

Clinical and biomarker responses to BI 655064, an antagonistic anti-CD40 antibody, in patients with active lupus nephritis: a randomized, double-blind, placebo-controlled, phase II trial

Arthritis Rheumatol. 2023;75(11):1983–93 doi: 10.1002/art.42557.

This phase II study of BI 655064 in patients with active LN did not meet the primary endpoint of CRR at Week 52, however, post-hoc analyses suggest a potential benefit of BI 655064 180 mg in patients with active LN.

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Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials

Rheumatology (Oxford) 2023;63(2):338–48 doi: 10.1093/rheumatology/kead253

The protection conferred from belimumab against renal flare development in patients treated for extra-renal SLE appears enhanced when administered along with antimalarials (AMA).

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April 2023

Evaluation of the LFA-REAL Clinician-reported Outcome (ClinRO) and Patient-reported Outcome (PRO): Prespecified Analysis of the Phase III Ustekinumab Trial in Patients with SLE

Lupus Sci Med. 2023 doi:10.1136/lupus-2022-000875

The Lupus Foundation of America Rapid Evaluation of Activity in Lupus (LFA-REAL) clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) systems show potential as a flexible resource in the evaluation of lupus disease activity and a simple, user-friendly outcome measure for SLE studies.

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