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.
The following information is from ClinicalTrials.gov
Last Update Posted: November 27, 2022
NCT04989517
Azora Therapeutics Australia Pty Ltd
Brief Summary:
This is a randomized, double-blind, placebo-controlled, parallel-group phase 1b study to evaluate AT193 in approximately 44 participants with HS. The treatment period will be 8 weeks followed by a 2-week nontreatment follow-up. The primary objective of this study is to evaluate the safety and tolerability of AT193. The secondary objectives of this study are to evaluate the preliminary efficacy in the treatment of HS.
Condition or Disease:
Hidradenitis Suppurativa
Intervention/Treatment:
Drug: AT193Phase:
Phase 1
Ages Eligible for Study:
18 Years and 80 Years (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.
Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.
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