Research Information System
RHEUMATOLOGY, vol.65, no.2, 2026 (SCI-Expanded, Scopus)
Objectives The study was designed to obtain a preliminary assessment of the safety and efficacy of SGX945 (dusquetide) for the treatment of aphthous oral and genital ulcers in Beh & ccedil;et's syndrome.Methods This was an open-label pilot study of intravenous dusquetide in patients with Beh & ccedil;et's syndrome who had at least two active oral and/or one active genital ulcer(s) at enrolment. Participants were treated twice weekly for 4 weeks and then followed for an additional 4 weeks. Efficacy assessments included number and pain of oral and genital ulcers, overall disease activity assessed using Beh & ccedil;et's Syndrome Current Activity Form and Beh & ccedil;et's Syndrome Activity Scale and health-related quality of life assessed using Beh & ccedil;et's Syndrome Quality of Life Index.Results Eight participants with oral ulcers were enrolled. Seven of eight participants reported a perceived benefit including reduction in number, duration and pain of oral ulcers. Comparison to historical placebo groups demonstrated a reduction in the number of ulcers, time to resolution of ulcers, area under the curve of the ulcer-days, oral pain and baseline quality of life metrics. The treatments were well-tolerated with no treatment-related AEs and no serious or severe adverse events recorded.Conclusion This small pilot study illustrates the potential efficacy and tolerability of SGX945 in patients with Beh & ccedil;et's syndrome who had ulcers despite being on colchicine maintenance therapy. The results justify further development of SGX945 for the treatment of Beh & ccedil;et's syndrome.Clinical trial registration Clinicaltrials.gov, http://clinicaltrials.gov, NCT06386744.