Can a new infusion tame the painful ulcers of Behcet's disease?
NCT ID NCT06386744
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This pilot study tests whether an experimental drug called dusquetide can reduce the number and pain of mouth and genital ulcers in people with Behcet's disease, an inflammatory condition. Participants receive the drug by intravenous infusion twice a week for four weeks, with follow-up visits for another month. The study tracks ulcer counts and pain scores to see if the treatment shows promise.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dusquetide (SGX945), given as an intravenous infusion
- What this could lead to
- If successful, this could point toward a new treatment to reduce painful ulcers in Behcet's disease, improving quality of life.
- What could go wrong
- This is a very small pilot study (8 participants), so results may not apply broadly. The drug's effectiveness and safety are still uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
8 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
-
Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine
Istanbul, Turkey (Türkiye)
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