Dusquetide for the Treatment of Behcet's Disease

Soligenix

Status and phase

Completed

Phase 2

Conditions

Behçet Disease

Treatments

Drug: Dusquetide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06386744

DUS-AUBD-01

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.