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Showing 24 results for “Phase 2”.

November 2024

Effect of iberdomide on cutaneous manifestations in systemic lupus erythematosus: a randomized phase 2 clinical trial

JAAD. 2024. Epub ahead of print DOI: 10.1016/j.jaad.2024.09.074

Werth et al. demonstrated that iberdomide significantly improved cutaneous lupus erythematosus (CLE) outcomes, particularly in subacute and chronic CLE patients, by reducing Cutaneous Lupus Area and Severity Index Activity (CLASI-A) scores. The study showed continued efficacy through 24 weeks, with the 0.45 mg dose providing the greatest improvement in patients with severe baseline scores, and iberdomide was well-tolerated over 104 weeks.

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July 2024

Efficacy and safety of upadacitinib or elsubrutinib alone or in combination for systemic lupus erythematosus: A Phase 2 randomized controlled trial

Arthritis Rheumatol 2024 DOI: 10.1002/art.42926 Epub ahead of print

Daily oral upadacitinib 30 mg and ABBV-599 high dose (elsubrutinib 60 mg QD + upadacitinib 30 mg) were effective in multiple outcome measures including disease activity, flares, time to first flare, and joint counts.

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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;28(4):257–73 DOI: 10.1080/14728214.2023.2273536

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