Status:
TERMINATED
A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid
Lead Sponsor:
Alkahest, Inc.
Conditions:
Pemphigoid, Bullous
Eligibility:
All Genders
60-95 years
Phase:
PHASE2
Brief Summary
This study will evaluate the therapeutic effect and safety of adjunctive AKST4290 in subjects with bullous pemphigoid (BP).
Detailed Description
This is a randomized, double-blind, placebo-controlled study to assess the therapeutic effect and safety of adjunctive AKST4290 in subjects with bullous pemphigoid (BP). Subjects will receive topical ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of mild to moderate BP at screening.
- Treatment naïve or initiation of whole-body high potency topical steroid treatment ≤ 7 days of screening (lesion-only treatment for any amount of time with any topical steroids prior to screening is allowed without restriction).
- Provide a signed and dated informed consent form in accordance with local regulations and/or IRB/IEC guidelines.
Exclusion
- Severe BP.
- Initiation of gliptins and other treatments (e.g., etanercept, sulfasalazine, furosemide, penicillin) that can trigger BP if this treatment was started within 4 weeks prior to screening and is considered possibly related to the onset of BP.
- Any concomitant medications in the last 3 months prior to screening and assessed by the investigator as possibly related to the development of BP.
- Planned use of intravenous immunoglobulin or other concomitant treatments for BP (i.e., doxycycline, dapsone) during the study period.
- Use of systemic immunosuppressants (i.e., mycophenolate, azathioprine, methotrexate) within 4 weeks prior to screening.
- Treatment with rituximab within 1 year prior to screening.
- Subjects taking warfarin.
- Use of systemic steroids (\>10 mg prednisone or equivalent/day) within 14 days of first dose of study agent or known diseases (other than BP) that could require the use of systemic steroids within the study period.
- Clinically relevant abnormal laboratory value at screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the screening phase).
- Participation in studies of investigational drugs must have been discontinued within 30 days or 5 half lives of the drug (whichever was longer) prior to screening.
Key Trial Info
Start Date :
January 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04499235
Start Date
January 30 2020
End Date
April 14 2021
Last Update
September 14 2023
Active Locations (8)
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1
Universitätsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für Dermatologie
Dresden, Germany, 01307
2
Universitätsklinikum Düsseldorf Klinik für Dermatologie
Düsseldorf, Germany, 40225
3
Universitätsklinikum Erlangen - Hautklinik
Erlangen, Germany, 91054
4
Universitätsklinikum Freiburg Klinik für Dermatologie und Venerologie
Freiburg im Breisgau, Germany, 79104