Dusquetide for the Treatment of Behcet's Disease

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

This is a clinical study to see if dusquetide can treat flares of oral and genital ulcers caused by Behcet's Disease. Study participants will receive an infusion of dusquetide twice a week for 4 weeks (8 treatments total), with weekly follow-up visits for an additional 4 weeks.

Study Overview

• Status: Completed
• Conditions: Behçet Disease
• Intervention / Treatment: Drug: Dusquetide

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SGX945; This is an open-label study and all participants will receive SGX945.	Drug: Dusquetide; 1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks; Other Names: SGX945; SGX942

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Oral Ulcers	The number of oral ulcers will be counted at baseline and each visit during the treatment period.	4 weeks
Number of Genital Ulcers	The number of genital ulcers will be counted at baseline and each visit during the treatment period.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain of Oral Ulcers	The pain of oral ulcers will be measured using a 10 cm Visual Analog Scale (VAS) at baseline and each visit during the treatment period.	4 weeks
Pain of Genital Ulcers	The pain of genital ulcers will be measured using a 10 cm Visual Analog Scale (VAS) at baseline and each visit during the treatment period.	4 weeks

Collaborators and Investigators

• Sponsor: Soligenix

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Actual): May 23, 2025
• Study Completion (Actual): June 17, 2025

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: dusquetide
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Eye Diseases; Skin Diseases; Skin Diseases, Vascular; Skin Diseases, Genetic; Uveal Diseases; Vasculitis; Panuveitis; Uveitis, Anterior; Uveitis; Hereditary Autoinflammatory Diseases; Behcet Syndrome
• Other Study ID Numbers: DUS-AUBD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No