Treatment of Behçet's Disease with dusquetide

Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behcet's Disease

This study is testing if dusquetide can help reduce painful mouth and genital sores in people with Behçet's Disease and improve their quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Soligenix (Industry-sponsored)
• Drugs / interventions: infliximab, adalimumab, golimumab, certolizumab, tocilizumab, secukinumab, methotrexate, cyclophosphamide
• Locations: 1 site (Istanbul)
• Trial ID: NCT06386744 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the efficacy of dusquetide in treating flares of oral and genital ulcers associated with Behçet's Disease. Participants will receive dusquetide infusions twice a week for four weeks, totaling eight treatments, followed by weekly follow-up visits for an additional four weeks. The study aims to assess the reduction in ulcer flare-ups and improve patient quality of life.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with Behçet's Disease who are experiencing active oral and/or genital ulcers.

Not a fit: Patients who are pregnant, breastfeeding, or have significant comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of ulcer flares in patients with Behçet's Disease.

How similar studies have performed: While there have been studies on treatments for Behçet's Disease, the specific use of dusquetide is a novel approach.

Eligibility criteria

Inclusion Criteria:

* Participants must have a clinical diagnosis of Behcet's Disease meeting the International Study Group criteria.
* Participants must have at least two oral ulcers and/or one genital ulcer on the day of randomization.
* Participants willing to follow the clinical protocol and voluntarily give their written informed consent.
* Female participants not pregnant or nursing and willing to undergo a pregnancy test prior to treatment initiation and at the end of the treatment period.

Exclusion Criteria:

* Pregnancy or mothers who are breast-feeding.
* All women of childbearing potential (WOCBP) and males with female partners who are WOCBP not willing to agree to the use of effective contraception during the trial.
* Evidence of significant renal, hepatic, hematologic or immunologic disease.
* Use of any investigational medication within 4 weeks prior to enrollment or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
* Having received concomitant immune modulating therapy (except colchicine or azathioprine) within:

  1. Ten days prior to enrollment for mycophenolate mofetil
  2. Four weeks (28 days) prior to enrollment for cyclosporine, methotrexate, cyclophosphamide, thalidomide and dapsone
  3. Oral and topical corticosteroids must have been tapered as appropriate and discontinued 3 days prior to day of enrollment
  4. At least 5 terminal half-lives for all biologics including, but not limited to, those listed below; within: i. Four weeks prior to enrollment for etanercept; ii. Eight weeks prior to enrollment for infliximab; iii. Ten weeks prior to enrollment for adalimumab, golimumab, certolizumab, abatacept, and tocilizumab; iv. Six months prior to enrollment for secukinumab.
* Having received oral or parenteral corticosteroids within 6 weeks (42 days) prior to enrollment.
* Having received apremilast (Otezla) within 4 weeks prior to enrollment.
* Presence of non- Behcet's Disease related genital ulcers, including both infectious and non-infectious etiologies.
* Active organ involvement requiring immunosuppressive treatment.

Where this trial is running

Istanbul

• Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine — Istanbul, Turkey (Recruiting)

Study contacts

• Study coordinator: Christopher Pullion, DO

Conditions Behçet Disease; dusquetide