Dusquetide for the Treatment of Behcet's Disease

Behçet Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386744
• Other study ID #: DUS-AUBD-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Soligenix
• Contact: Christopher Pullion, DO
• Phone: 6095388200
• Email: cpullion[@]soligenix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behçet Disease
• Behcet Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Soligenix

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Oral Ulcers	The number of oral ulcers will be counted at baseline and each visit during the treatment period.	4 weeks
Primary	Number of Genital Ulcers	The number of genital ulcers will be counted at baseline and each visit during the treatment period.	4 weeks
Secondary	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
Secondary	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