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

Primary Purpose

Hidradenitis Suppurativa

Status
Active
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
AT193
Sponsored by
Azora Therapeutics Australia Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Woden Dermatology
  • East Sydney Doctors
  • Holdsworth House Medical Practice
  • Premier Specialists
  • Novatrials
  • Veracity Clinical Research
  • North Eastern Health Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AT193

Placebo

Arm Description

Topical applied daily

Topical applied daily

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events

Secondary Outcome Measures

Full Information

First Posted
July 26, 2021
Last Updated
January 27, 2023
Sponsor
Azora Therapeutics Australia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04989517
Brief Title
Study of Efficacy and Safety of Investigational Treatment in Patients With Hidradenitis Suppurativa
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azora Therapeutics Australia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AT193
Arm Type
Experimental
Arm Description
Topical applied daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical applied daily
Intervention Type
Drug
Intervention Name(s)
AT193
Intervention Description
Topical
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Woden Dermatology
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
East Sydney Doctors
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Premier Specialists
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Novatrials
City
Kotara
State/Province
New South Wales
ZIP/Postal Code
2289
Country
Australia
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
North Eastern Health Specialists
City
Campbelltown
State/Province
South Australia
ZIP/Postal Code
5074
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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