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Study of Efficacy and Safety of Investigational Treatment in Patients With Hidradenitis Suppurativa

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04989517
Recruitment Status : Recruiting
First Posted : August 4, 2021
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
Azora Therapeutics Inc. ( Azora Therapeutics Australia Pty Ltd )

Study Description
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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 Intervention/treatment Phase
Hidradenitis Suppurativa Drug: AT193 Phase 1

Study Design
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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 : June 15, 2022
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AT193
Topical applied daily
 Drug: AT193
Topical
Placebo Comparator: Placebo
Topical applied daily
 Drug: AT193
Topical


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: 10 weeks ]

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Matt Davidson, PhD 818-276-6726 matt@azoratherapeutics.com

Locations
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Australia, New South Wales
East Sydney Doctors Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: David Baker, MD         
Holdsworth House Medical Practice Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: John Frew, MD         
Premier Specialists Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Deirdre Murrell, MD         
Novatrials Recruiting
Kotara, New South Wales, Australia, 2289
Contact: Alicia Thorton, MD         
Australia, South Australia
North Eastern Health Specialists Recruiting
Campbelltown, South Australia, Australia, 5074
Contact: Shireen Sidhu, MD         
Sponsors and Collaborators
Azora Therapeutics Australia Pty Ltd
More Information
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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: December 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration