Trial Outcomes & Findings for Dusquetide for the Treatment of Behcet's Disease (NCT NCT06386744)

NCT ID: NCT06386744

Last Updated: 2026-08-26

Results Overview

The number of oral ulcers were counted at baseline and each visit during the treatment period.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

4 weeks

Results posted on

2026-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	SGX945 1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dusquetide for the Treatment of Behcet's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SGX945 n=8 Participants 1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks
Age, Continuous	43 years STANDARD_DEVIATION 12.2 • n=31 Participants
Sex: Female, Male Female	6 Participants n=31 Participants
Sex: Female, Male Male	2 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=31 Participants
Race (NIH/OMB) White	8 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=31 Participants
Region of Enrollment Turkey	8 Participants n=31 Participants

PRIMARY outcome

Timeframe: 4 weeks

The number of oral ulcers were counted at baseline and each visit during the treatment period.

Outcome measures

Outcome measures
Measure	SGX945 n=8 Participants 1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks
Number of Oral Ulcers End of Treatment	1.6 Oral Ulcers Interval -0.4 to 3.6
Number of Oral Ulcers Baseline	2.9 Oral Ulcers Interval 2.0 to 5.0

PRIMARY outcome

Timeframe: 4 weeks

The number of genital ulcers will be counted at baseline and each visit during the treatment period.

Outcome measures

Outcome measures
Measure	SGX945 n=8 Participants 1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks
Number of Genital Ulcers Baseline	0 Genital Ulcers Interval 0.0 to 0.0
Number of Genital Ulcers End of Treatment	0 Genital Ulcers Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	SGX945 n=8 Participants 1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks
Change in Pain of Oral Ulcers From Baseline to End of Treatment	-47 scores on a scale Interval -78.3 to -16.5

SECONDARY outcome

Timeframe: 4 weeks

Population: Data could not be collected as there were no participants with genital ulcers.

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.

Outcome measures

Outcome data not reported

Adverse Events

SGX945

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SGX945 n=8 participants at risk 1.5 mg/mL dusquetide administered as a 4 minute IV infusion, twice per week for 4 weeks
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • From enrollment until end of follow-up, up to 8 weeks
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • From enrollment until end of follow-up, up to 8 weeks
Cardiac disorders Sinus bradycardia	12.5% 1/8 • From enrollment until end of follow-up, up to 8 weeks
Nervous system disorders Headache	12.5% 1/8 • From enrollment until end of follow-up, up to 8 weeks
Skin and subcutaneous tissue disorders Macule	12.5% 1/8 • From enrollment until end of follow-up, up to 8 weeks
Vascular disorders Hypertension	12.5% 1/8 • From enrollment until end of follow-up, up to 8 weeks
General disorders Administration site extravasation	12.5% 1/8 • From enrollment until end of follow-up, up to 8 weeks
General disorders Peripheral swelling	12.5% 1/8 • From enrollment until end of follow-up, up to 8 weeks
Infections and infestations Upper respiratory tract infection	25.0% 2/8 • From enrollment until end of follow-up, up to 8 weeks
Infections and infestations Tinnea infection	12.5% 1/8 • From enrollment until end of follow-up, up to 8 weeks

Additional Information

Oreola Donini, PhD/Chief Scientific Officer

Soligenix, Inc.

Phone: 609-538-8200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place