Study of Efficacy and Safety of Investigational Treatment in Patients With Hidradenitis Suppurativa
- Registration Number
- NCT04989517
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo AT193 Topical applied daily AT193 AT193 Topical applied daily
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events 10 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Premier Specialists
🇦🇺Kogarah, New South Wales, Australia
Holdsworth House Medical Practice
🇦🇺Darlinghurst, New South Wales, Australia
East Sydney Doctors
🇦🇺Darlinghurst, New South Wales, Australia
Veracity Clinical Research
🇦🇺Woolloongabba, Queensland, Australia
Novatrials
🇦🇺Kotara, New South Wales, Australia
North Eastern Health Specialists
🇦🇺Campbelltown, South Australia, Australia
Woden Dermatology
🇦🇺Phillip, Australian Capital Territory, Australia