Adults aged 18 to 80 with hidradenitis suppurativa (HS), may qualify for this research trial. Individuals must have a diagnosis or signs and symptoms consistent with HS for at least 3 months. Patients must have mild to moderate HS with a minimum of two active abscesses or inflammatory nodule (AN) count. Stable disease for at least 2 months before screening, is also required.
Participants will receive investigational topical medication (active study drug) or placebo, as an ointment. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses will also be provided.
Study participation will last about 15 weeks and involve about 5 visits to the study centre, plus 1 telephone visit.
NCT04989517
Azora Therapeutics Australia Pty Ltd
Brief Summary:
Azora Therapeutics Australia Pty Ltd
Condition or Disease:
Hidradenitis Suppurativa
Intervention/Treatment:
Drug: AT193 Drug: AT193Phase:
Phase 1
Ages Eligible for Study:
18 Years and 80 Years (Adult,Older Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
Diagnosis of HS or signs and symptoms consistent with HS for at least 3 months before screening in the judgment of the investigator.
Stable disease for at least 2 months before screening in the judgment of the investigator.
A woman of childbearing potential must use appropriate contraceptive measures during the study period.
A woman of childbearing potential must have a negative urine pregnancy test result at screening.
Written informed consent must be obtained before any study procedure is performed.
Exclusion Criteria:
Pregnant or breastfeeding.
Any active skin disease that may interfere with evaluation of study drug or outcome assessment.
History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator.
Change in smoking or marijuana history within 3 months before Day 1 or planned during study period.
Hectorville - North Eastern Health Specialists
Woolloongabba - Veracity Clinical Research
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