Behçet DiseasePhase 2NCT06386744

Dusquetide for the Treatment of Behcet's Disease

A Phase 2 study testing Dusquetide in people with Behçet Disease, run by Soligenix at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Behçet Disease
What is being tested?: Dusquetide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 18 Nov 2024to 17 Jun 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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:
Ten days prior to enrollment for azathioprine and mycophenolate mofetil,

Show all 13Show fewer

Four weeks (28 days) prior to enrollment for cyclosporine, methotrexate, cyclophosphamide, thalidomide and dapsone
Oral and topical corticosteroids must have been tapered as appropriate and discontinued 3 days prior to day of enrollment
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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine
Istanbul

Other trials in Turkey (Türkiye)

About this study

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

Conditions: Behçet Disease
Being tested: Dusquetide
Keywords: dusquetide
Medical subject headings: Behcet Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DusquetideDrug
Also called SGX945, SGX942
1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks

Study groups in NCT06386744
Study group	Role	What they receive
SGX945	Experimental	This is an open-label study and all participants will receive SGX945. Receives: Drug: Dusquetide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Oral Ulcers
The number of oral ulcers were counted at baseline and each visit during the treatment period.
Measured: 4 weeks
Number of Genital Ulcers
The number of genital ulcers will be counted at baseline and each visit during the treatment period.
Measured: 4 weeks

Secondary outcomes (2)

Change in Pain of Oral Ulcers From Baseline to End of Treatment
The pain of oral ulcers was measured using a 100 mm Visual Analog Scale (VAS) at baseline and each visit during the treatment period. The minimum score is 0 mm (no pain) and the maximum score is 100 mm (maximum pain). The change in pain is the difference between the score at baseline and the score at the end of treatment, where a negative value indicates a reduction in pain.
Measured: 4 weeks
Change in Pain of Genital Ulcers From Baseline to End of Treatment
The pain of genital ulcers was measured using a 100 mm Visual Analog Scale (VAS) at baseline and each visit during the treatment period. The minimum score is 0 mm (no pain) and the maximum score is 100 mm (maximum pain). The change in pain is the difference between the score at baseline and the score at the end of treatment, where a negative value indicates a reduction in pain.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202417 Jun 2025

First posted26 Apr 2024
Study start18 Nov 2024
Primary completion23 May 2025
Study completion17 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Behçet DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06386744
Sponsor's protocol ID: DUS-AUBD-01
Status last verified: Aug 2026
First submitted: 23 Apr 2024
Last updated: 26 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41400947

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Behçet Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behcet's Disease
ClinicalTrials.gov ID: NCT06386744
Acronym / sponsor ID: DUS-AUBD-01
Conditions: Behçet Disease
Keywords: dusquetide
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: SoligenixIndustry (pharma, biotech, devices)
Study start: 18 Nov 2024 (actual)
Primary completion: 23 May 2025 (actual)
Study completion: 17 Jun 2025 (actual)
First posted: 26 Apr 2024 (actual)
Results: Posted 26 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SGX945	Experimental	Drug: DusquetideThis is an open-label study and all participants will receive SGX945.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (13 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DusquetideAlso: SGX945, SGX9421.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks	Drug	SGX945

Primary outcome

Number of Oral Ulcers
Time frame: 4 weeks
The number of oral ulcers were counted at baseline and each visit during the treatment period.
Number of Genital Ulcers
Time frame: 4 weeks
The number of genital ulcers will be counted at baseline and each visit during the treatment period.

2 secondary outcomes

Change in Pain of Oral Ulcers From Baseline to End of Treatment
Time frame: 4 weeks
Change in Pain of Genital Ulcers From Baseline to End of Treatment
Time frame: 4 weeks

Results and safety

Results posted to the registry on 26 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SGX945	8	8

Primary outcome: Number of Oral Ulcers

Time frame: 4 weeks. Mean (95% Confidence Interval). Unit: Oral Ulcers

Measure	SGX945 n = 8
Baseline	2.9 (2 to 5)
End of Treatment	1.6 (-0.4 to 3.6)

Primary outcome: Number of Genital Ulcers

Time frame: 4 weeks. Mean (Full Range). Unit: Genital Ulcers

Measure	SGX945 n = 8
Baseline	0 (0 to 0)
End of Treatment	0 (0 to 0)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SGX945	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41400947Donini 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.
Individual participant dataSharing planned: No

Related trials for Behçet Disease

Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Not yet recruitingObservational study
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
Pericarditis, Tako-TSUBO Cardiomyopathy
RecruitingPhase 3
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Behçet Disease
Recruiting
Deployment o the Multidisciplinary Prospective Cohort Imminent
Chronic Inflammatory Disease, Angioedema
Active, not recruitingPhase 4
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
Rheumatoid Arthritis, Spondylitis, Ankylosing

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dusquetide in people with Behçet Disease, run by Soligenix at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Oral Ulcers (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06386744, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.