Study of Efficacy and Safety of Investigational Treatment in Patients With Hidradenitis Suppurativa
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04989517 |
Recruitment Status :
Active, not recruiting
First Posted : August 4, 2021
Last Update Posted : January 30, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hidradenitis Suppurativa | Drug: AT193 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of AT193 in the Treatment of Patients With Hidradenitis Suppurativa |
Actual Study Start Date : | November 23, 2021 |
Estimated Primary Completion Date : | February 2023 |
Estimated Study Completion Date : | February 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: AT193
Topical applied daily
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Drug: AT193
Topical |
Placebo Comparator: Placebo
Topical applied daily
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Drug: AT193
Topical |
- Incidence of treatment-emergent adverse events [ Time Frame: 10 weeks ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04989517
Australia, Australian Capital Territory | |
Woden Dermatology | |
Phillip, Australian Capital Territory, Australia, 2606 | |
Australia, New South Wales | |
East Sydney Doctors | |
Darlinghurst, New South Wales, Australia, 2010 | |
Holdsworth House Medical Practice | |
Darlinghurst, New South Wales, Australia, 2010 | |
Premier Specialists | |
Kogarah, New South Wales, Australia, 2217 | |
Novatrials | |
Kotara, New South Wales, Australia, 2289 | |
Australia, Queensland | |
Veracity Clinical Research | |
Woolloongabba, Queensland, Australia, 4102 | |
Australia, South Australia | |
North Eastern Health Specialists | |
Campbelltown, South Australia, Australia, 5074 |
Responsible Party: | Azora Therapeutics Australia Pty Ltd |
ClinicalTrials.gov Identifier: | NCT04989517 |
Other Study ID Numbers: |
HS01 |
First Posted: | August 4, 2021 Key Record Dates |
Last Update Posted: | January 30, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration |