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Showing 22 results for “Phase 2”.

February 2024

Evaluation of RNase Therapy in Systemic Lupus Erythematosus: A Randomised Phase 2a Clinical Trial of RSLV-132

Lupus Sci Med. 2024;11:e001113 DOI 10.1136/lupus-2023-001113

Treatment with RSLV-132 was associated with lower rates of SAEs than placebo, although RSLV-132 therapy was not associated with a significant improvement in the mean CLASI score relative to placebo. However, results suggest that further evaluations of RSLV-132 in SLE should be undertaken with patients with more active disease who are most likely to benefit from RNase therapy.

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January 2024

Telitacicept in Patients with Active Systemic Lupus Erythematosus: Results of A Phase 2b, Randomised, Double-blind, Placebo-controlled Trial

Ann Rheum Dis. 2023; DOI: 10.1136/ard-2023-224854

This Phase 2 trial demonstrated the efficacy and acceptable safety profile of telitacicept in patients with SLE. The safety profile of telitacicept was comparable with that observed in clinical trials of other B cell-targeting agents.

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December 2023

Kidney Outcomes and Preservation of Kidney Function with Obinutuzumab in Patients with Lupus Nephritis: A Post Hoc Analysis of the NOBILITY Trial

Arthritis Rheumatol. 2023 DOI 10.1002/art.42734

This post hoc analysis of the Phase 2 NOBILITY trial determined that obinutuzumab plus standard of care improved the likelihood of long-term preservation of kidney function and improved kidney function with less glucocorticoid use in patients with lupus nephritis.

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November 2023

Emerging Immunotherapeutic Strategies for Cutaneous Lupus Erythematosus: An Overview of Recent Phase 2 and 3 Clinical Trials

Expert Opin Emerg Drugs 2023; 20:1-17 DOI: 10.1080/14728214.2023.2273536 Epub ahead of print

Current treatments for refractory CLE are insufficient, often leading to suboptimal disease control, and demanding escalated therapies associated with systemic toxicities. However, recent Phase 2 & 3 trials offer promising results, suggesting new therapeutics approved for CLE are on the horizon.

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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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May 2023

Litifilimab (BIIB059), a Promising Investigational Drug for Cutaneous Lupus Erythematosus

Expert Opin Investig Drugs 2023;15:1-9 doi 10.1080/13543784.2023.2212154

Cho, et al. discuss the current challenges in the approval of CLE drugs and suggest outcome measures that could streamline the process. They also discuss the pharmacodynamics of litifilimab and the current status of clinical trials.

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March 2023
December 2022
November 2022

Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus

N Engl J Med. 2022;387(10):894–904 doi: 10.1056/NEJMoa2118025

Phase 2 study, in patients with systemic lupus erythematosus, shows that litifilimab is associated with a greater reduction from baseline in the number of swollen and tender joints than placebo, over a period of 24 weeks.

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