Dusquetide for the Treatment of Behcet's Disease

NCT ID: NCT06386744

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2025-06-17

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SGX945

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

Group Type: EXPERIMENTAL

Dusquetide

Intervention Type: DRUG

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

Interventions

Dusquetide

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

Intervention Type: DRUG

Other Intervention Names

SGX945; SGX942

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soligenix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DUS-AUBD-01

Identifier Type: -

Identifier Source: org_study_id