Skip to main content
OpenTrials
Completed

NCT Number: NCT04989517

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Woden Dermatology, Phillip, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AT193

Drug

Topical

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Azora Therapeutics Australia Pty Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2021
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.