Dusquetide for the Treatment of Behcet's Disease

Last updated: March 27, 2025
Sponsor: Soligenix
Overall Status: Active - Recruiting

Phase

2

Condition

Lupus

Treatment

Dusquetide

Clinical Study ID

NCT06386744
DUS-AUBD-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have a clinical diagnosis of Behcet's Disease meeting theInternational Study Group criteria.

  • Participants must have at least two oral ulcers and/or one genital ulcer on the dayof randomization.

  • Participants willing to follow the clinical protocol and voluntarily give theirwritten informed consent.

  • Female participants not pregnant or nursing and willing to undergo a pregnancy testprior to treatment initiation and at the end of the treatment period.

Exclusion

Exclusion Criteria:

  • Pregnancy or mothers who are breast-feeding.

  • All women of childbearing potential (WOCBP) and males with female partners who areWOCBP 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 5pharmacokinetic/pharmacodynamic half-lives (whichever is longer).

  • Having received concomitant immune modulating therapy (except colchicine orazathioprine) within:

  1. Ten days prior to enrollment for 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 anddiscontinued 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 toenrollment 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 toenrollment.

  • Having received apremilast (Otezla) within 4 weeks prior to enrollment.

  • Presence of non- Behcet's Disease related genital ulcers, including both infectiousand non-infectious etiologies.

  • Active organ involvement requiring immunosuppressive treatment.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Dusquetide
Phase: 2
Study Start date:
November 18, 2024
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine

    Istanbul,
    Turkey

    Active - Recruiting

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