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CompletedNCT04989517Updated Mar 15, 2024

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

A Phase 1 interventional study of AT193 in Hidradenitis Suppurativa, sponsored by Azora Therapeutics Australia Pty Ltd. Completed at 7 sites in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Azora Therapeutics Australia Pty Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hidradenitis Suppurativa
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 49 is close to the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Azora Therapeutics Australia Pty Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    AT193

    Topical applied daily

    Drug: AT193

  • Placebo comparator
    Placebo

    Topical applied daily

    Drug: AT193

Interventions

  • DrugAT193

    Topical

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: 10 weeks

07

Study locations

7 sites
  • Woden Dermatology
    Phillip, Australian Capital Territory 2606, Australia
  • East Sydney Doctors
    Darlinghurst, New South Wales 2010, Australia
  • Holdsworth House Medical Practice
    Darlinghurst, New South Wales 2010, Australia
  • Premier Specialists
    Kogarah, New South Wales 2217, Australia
  • Novatrials
    Kotara, New South Wales 2289, Australia
  • Veracity Clinical Research
    Woolloongabba, Queensland 4102, Australia
  • North Eastern Health Specialists
    Campbelltown, South Australia 5074, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04989517
Lead sponsor
Azora Therapeutics Australia Pty Ltd
Responsible party
Sponsor
First posted
Aug 4, 2021
Start date
Nov 23, 2021
Primary completion
Mar 15, 2023
Completion
Mar 15, 2023
Last update
Mar 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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