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Showing 14 results for “phase II”.

February 2024

Predictors of Renal Flares in Systemic Lupus Erythematosus: A Post-hoc Analysis of Four Phase III Clinical Trials of Belimumab

Rheumatology (Oxford) 2024 DOI: 10.1093/rheumatology/keae023 Epub ahead of print

High baseline proteinuria levels, hypoalbuminaemia, and C3 consumption were associated with
renal flare development. Renal flares remain common in patients with SLE, however causative factors are still largely unknown. Jagerback, et al. conducted a post-hoc analysis of pooled BLISS trial data to identify predictors of renal flares.

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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

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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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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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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December 2022
January 2023
December 2022

Low-dose Interleukin-2 Therapy in Active Systemic Lupus Erythematosus (LUPIL-2): A Multicentre, Double-blind, Randomised and Placebo-controlled Phase II Trial

Ann Rheum Dis. 2022;81:1685–1694

Phase II proof-of-concept trial confirms that low-dose IL-2 therapy can safely and selectively expand the Treg population, and is capable of reducing disease activity in patients with SLE.

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A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus

Arthritis Rheumatol. 2022. Epub ahead of print doi: 10.1002/art.42392

Long-term extension study shows an acceptable long-term safety profile of anifrolumab in SLE, in addition to sustained improvements in disease activity and reduction in glucocorticoid use.

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July 2022

Mechanism of action of baricitinib and identification of biomarkers and key immune pathways in patients with active systemic lupus erythematosus

Dörner T, et al. Ann Rheum Dis. 2022. Epub ahead of print. doi:10.1136/annrheumdis-2022-222335.

Phase II study results suggest that baricitinib 4 mg downregulates key cytokines that are upregulated in patients with SLE.

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