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Showing 16 results for “phase II”.

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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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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March 2022

Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis

Ann Rheum Dis. 2022;81(4):496–506 doi: 10.1136/annrheumdis-2021-221478

Despite not meeting the primary endpoint, this Phase II trial of anifrolumab in patients with active lupus nephritis (LN) demonstrates that anifrolumab IR is associated with numerical improvements over placebo across endpoints – including complete renal response – in patients with active LN.

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