Dusquetide for the Treatment of Behcet's Disease

Phase 2

Recruiting

• Conditions: Behçet Disease
• Interventions: Drug: Dusquetide

• Registration Number: NCT06386744
• Lead Sponsor: Soligenix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Study Start: 2024-11-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SGX945	Dusquetide	This is an open-label study and all participants will receive SGX945.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain of Oral Ulcers	4 weeks	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.
Pain of Genital Ulcers	4 weeks	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.

Trial Locations

Locations (1)

Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine; 🇹🇷 Istanbul, Turkey