Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Mar;92(3):435-443.
doi: 10.1016/j.jaad.2024.09.074. Epub 2024 Oct 25.

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

Victoria P Werth  1 , Joan T Merrill  2 , Richard Furie  3 , Thomas Dörner  4 , Ronald van Vollenhoven  5 , Peter Lipsky  6 , Michael Weiswasser  7 , Shimon Korish  7 , Peter H Schafer  7 , Mark Stern  7 , Stan Li  7 , Nikolay Delev  7
Affiliations
Free article
Clinical Trial

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

Victoria P Werth et al. J Am Acad Dermatol. 2025 Mar.
Free article

Abstract

Background: Iberdomide, a cereblon modulator, promotes degradation of transcription factors Ikaros and Aiolos.

Objective: Evaluate iberdomide efficacy and safety in cutaneous lupus erythematosus (CLE) in a phase 2 study.

Methods: Patients were randomized (2:2:1:2) to iberdomide 0.45 (n = 81), 0.30 (n = 82), or 0.15 mg (n = 42) or placebo (n = 83) daily while continuing background lupus medications.

Results: The mean (SD) baseline Cutaneous Lupus Area and Severity Index Activity (CLASI-A) score was 6.9 (7.0); 28% of patients had a score ≥8; 56% had acute CLE, 29% chronic CLE, and 16% subacute CLE. Mean CLASI-A improvement in patients with baseline score ≥8 was 39.7% for iberdomide 0.45 mg versus 20.1% for placebo at week 4 (P = .032), with continued improvement through week 24 (66.7% vs 54.2%; P = .295). Proportions of patients achieving ≥50% CLASI-A reduction from baseline at week 24 were significantly greater for iberdomide 0.45 mg versus placebo for patients with subacute (91.7% vs 52.9%, P = .035) and chronic (62.1% vs 27.8%; P = .029) CLE but not for the overall population (55.6% vs 44.6%) or patients with baseline CLASI-A ≥8 (66.7% vs 50.0%).

Limitations: Small patient subgroups of CLE subtypes.

Conclusions: Iberdomide showed beneficial effects when added to background lupus medications in patients with subacute and chronic CLE.

Keywords: Aiolos; Cutaneous Lupus Area and Severity Index Activity score; Ikaros; cereblon modulator; cutaneous lupus erythematosus; systemic lupus erythematosus.

PubMed Disclaimer

Conflict of interest statement

Conflicts of interest Dr Werth reported consultancy from Celgene, Medimmune, Resolve, Genentech, Idera, Janssen, Lilly, Biogen, Bristol Myers Squibb, Gilead, Amgen, Medscape, Nektar, Incyte, EMD Serono, CSL Behring, Principia, Crisalis, Viela Bio, Argenx, Kirin, AstraZeneca, AbbVie, GlaxoSmithKline, Cugene, UCB, Corcept, and Beacon Bioscience and research support from Celgene, Janssen, Biogen, Gilead, AstraZeneca, Viela Bio, Amgen, and Lupus Research Alliance/Bristol Myers Squibb. Dr Merrill reported conducting research for UCB, GlaxoSmithKline, AbbVie, EMD Serono, RemeGen, Celgene/Bristol Myers Squibb, AstraZeneca, Lilly, Daiichi Sankyo, Servier, ImmuPharma, Amgen, Janssen, Genentech, Resolve, Alpine, Aurinia, Astellas, Alexion, and Provention – consultancy; GlaxoSmithKline, and AstraZeneca. Dr Furie reported research/grant support (consultancy) from Bristol Myers Squibb. Dr Dörner reported consultancy for AbbVie and EMD/Serono, support for clinical studies (consultancy) from Bristol Myers Squibb/Celgene, Novartis, Regeneron/Sanofi, and Roche/Genentech, and support for clinical studies (consultancy, speaker) from Eli Lilly and Janssen. Dr Vollenhoven reported research support from Bristol Myers Squibb, GlaxoSmithKline, and Eli Lilly, research support (consultancy, speaker) from UCB, support for educational programs (consultancy, speaker) from Pfizer, support for educational programs from Roche, consultancy (speaker) for AbbVie, AstraZeneca, Biogen, Biotest, Celgene, Galapagos, and Janssen, and consultancy for Gilead and Servier. Dr Lipsky reported grant support from RILITE Foundation. Authors Weiswasser and Li, and Drs Korish, Schafer, Stern, and Delev reported being employed by Bristol Myers Squibb.

Publication types