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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGX945 | Experimental | This is an open-label study and all participants will receive SGX945. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dusquetide | Drug | 1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oral Ulcers | The number of oral ulcers will be counted at baseline and each visit during the treatment period. | 4 weeks |
| Number of Genital Ulcers | The number of genital ulcers will be counted at baseline and each visit during the treatment period. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
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:
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41400947 | Derived | Donini O, Sulu B, Pullion C, Rumage A, Straube R, Schaber C, Hatemi G. Results from a pilot study of dusquetide for the treatment of aphthous ulcers associated with Behcet's syndrome. Rheumatology (Oxford). 2026 Feb 4;65(2):keaf682. doi: 10.1093/rheumatology/keaf682. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2026 | Jul 2, 2026 | 5 | ||
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
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| ID | Term |
|---|---|
| C000614919 | dusquetide |
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| 4 weeks |
| D014605 |
| Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |