Clear Search

Showing 5 results for “Phase 2” published 2024.

December 2024

Comparison of a voclosporin-based triple immunosuppressive therapy to high-dose glucocorticoid-based immunosuppressive therapy: A propensity analysis of the AURA-LV and AURORA 1 studies and ALMS

Lupus Science & Medicine 2024;11:e001319 DOI: 10.1136/lupus-2024-001319

Dall’Era et al. conducted a propensity analysis to compare voclosporin-based triple immunosuppressive therapy with high-dose GC-based regimens for active LN. Voclosporin showed fewer AEs, improved safety, and significantly reduced proteinuria over six months, suggesting a superior risk-benefit profile for patients with lupus nephritis.

more…

Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial

Lancet Rheumatol. 2024. Epub ahead of print. DOI: 10.1016/S2665-9913(24)00246-7

Askanase et al. assessed the efficacy, safety, and tolerability of cenerimod in patients with moderate-to-severe SLE. While the primary endpoint of reducing mSLEDAI-2K scores at Month 6 was not achieved, cenerimod 4.0mg showed a significant reduction in disease activity versus placebo. Adverse events, including lymphopenia, were dose-dependent but manageable, and overall treatment was well tolerated.

more…

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.

more…

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.

more…

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.

more…