Dusquetide for the Treatment of Behcet's Disease

NCT06386744 | Completed Phase 2 FDA Drug

• 1 other identifier: DUS-AUBD-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behçet Disease

Keywords

dusquetide

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pain of Oral Ulcers

  4 weeks

• Pain of Genital Ulcers

  4 weeks

Study Arms (1)

SGX945

EXPERIMENTAL

This is an open-label study and all participants will receive SGX945.

Drug: Dusquetide

Interventions

Dusquetide DRUG

1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks

Also known as: SGX945, SGX942

SGX945

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Ten days prior to enrollment for mycophenolate mofetil
• Four weeks (28 days) prior to enrollment for cyclosporine, methotrexate, cyclophosphamide, thalidomide and dapsone
• Oral and topical corticosteroids must have been tapered as appropriate and discontinued 3 days prior to day of enrollment
• 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.

Sponsors & Collaborators

• Soligenix: lead

Study Sites (1)

Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Donini O, Sulu B, Pullion C, Rumage A, Straube R, Schaber C, Hatemi G. Results from a pilot study of dusquetide for the treatment of aphthous ulcers associated with Behcet syndrome. Rheumatology (Oxford). 2025 Dec 16:keaf682. doi: 10.1093/rheumatology/keaf682. Online ahead of print.

  PMID: 41400947 DERIVED

MeSH Terms

Conditions

Behcet Syndrome

Interventions

dusquetide

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: November 18, 2024
• Primary Completion: May 23, 2025
• Study Completion: June 17, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)