Dusquetide for the Treatment of Behcet's Disease

August 4, 2026 updated by: Soligenix

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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) within:

    1. Ten days prior to enrollment for azathioprine and 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain of Oral Ulcers From Baseline to End of Treatment
Time Frame: 4 weeks
The pain of oral ulcers was measured using a 100 mm Visual Analog Scale (VAS) at baseline and each visit during the treatment period. The minimum score is 0 mm (no pain) and the maximum score is 100 mm (maximum pain). The change in pain is the difference between the score at baseline and the score at the end of treatment, where a negative value indicates a reduction in pain.
4 weeks
Change in Pain of Genital Ulcers From Baseline to End of Treatment
Time Frame: 4 weeks
The pain of genital ulcers was measured using a 100 mm Visual Analog Scale (VAS) at baseline and each visit during the treatment period. The minimum score is 0 mm (no pain) and the maximum score is 100 mm (maximum pain). The change in pain is the difference between the score at baseline and the score at the end of treatment, where a negative value indicates a reduction in pain.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soligenix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 26, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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