Clinical trial NCT06386744: Dusquetide for the Treatment of Behcet's Disease
Official title: Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behcet's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Behçet Disease
Keywords: dusquetide
Lead sponsor: Soligenix
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Oral Ulcers
timeFrame: 4 weeks
measure: Number of Genital Ulcers
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain of Oral Ulcers
timeFrame: 4 weeks
measure: Pain of Genital Ulcers
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine
Study officials:
References: