A randomized, double-blind, placebo-controlled phase 2 study of eltrekibart, a novel septa-specific monoclonal antibody to CXCR1/2 ligands, in adults with hidradenitis suppurativa - 19/01/26
Abstract |
Background |
Human CXC motif chemokine receptors 1 and 2 ligands are implicated in hidradenitis suppurativa (HS) pathogenesis.
Objective |
To evaluate the efficacy and safety of eltrekibart, a monoclonal antibody targeting the CXC motif chemokine receptors 1 and 2 pathway, in HS.
Methods |
In this phase 2 double-blind trial (NCT04493502), adults with moderate-to-severe HS were randomized 2:1 to receive eltrekibart 600 mg or placebo every 2 weeks. The primary endpoint was the proportion of participants achieving ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count relative to baseline (HS Clinical Response [HiSCR50]) at week 16. A prespecified Bayesian augmented control analysis was also implemented on the primary endpoint, which sourced historical placebo data from phase 3 HS trials.
Results |
At week 16, 48.9% of 47 eltrekibart-treated participants and 31.8% of 20 placebo-treated participants achieved HiSCR50 ( P = .19). For the augmented-control analysis, 65.6% of eltrekibart-treated participants and 32.3% of placebo-treated participants achieved HiSCR50 at week 16; posterior probability of eltrekibart superiority was 99.9%, with a 61.9% probability of ≥30% difference. Most treatment-emergent adverse events were mild or moderate.
Limitations |
Short timeline, limited geography, and small sample size.
Conclusion |
Neutralizing CXC motif chemokine receptors 1 and 2 ligands offer a promising HS treatment strategy.
Le texte complet de cet article est disponible en PDF.Key words : CXCR1/2 signaling, eltrekibart, hidradenitis suppurativa, LY3041658
Abbreviations used : AE, AN, CI, CCL, CXCL, CXCR1/2, HiSCR50, HiSCR75, HS, IHS4, NRS, SD, SE, TEAE
Plan
| Drs Forman and Patel are Co-first authors. |
|
| Dr Nirula is currently affiliated with the Recludix Pharma, San Diego, California. |
|
| Funding sources: Supported by Eli Lilly and Company (Indianapolis, IN, USA). |
|
| Patient consent: All study participants provided written informed consent. |
|
| IRB approval status: The protocol, amendments, and informed consent forms received appropriate institutional review board approval prior to trial initiation (IRB approval number 20201397, approved June 22, 2020). |
|
| Prior presentation: Portions of this work were presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting (March 17-21, 2023). |
|
| Data availability: Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org . |
Vol 94 - N° 2
P. 530-538 - février 2026 Retour au numéro
Article précédent
- Saturated saline immersion for the treatment of refractory plantar warts: An open-label, one-arm, single-center trial
- Yinglin Xu, Tingting Li, Xinzheng Liang, Siyuan Jia, Li Wang, Zhaohua Zhu, Lei Yu, Tangde Zhang
- JAAD Game Changers: Most cutaneous squamous cell carcinoma recurrences occur in the first 3 years after diagnosis: A multicenter retrospective cohort study
- Craig Fisher, Eden Lake
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?