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

Hidradenitis Suppurativa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04989517
• Other study ID #: HS01
• Status: Completed
• Phase: Phase 1
• Start date: November 23, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2024
• Source: Azora Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• AT193
Topical

Locations

Country	Name	City	State
Australia	North Eastern Health Specialists	Campbelltown	South Australia
Australia	East Sydney Doctors	Darlinghurst	New South Wales
Australia	Holdsworth House Medical Practice	Darlinghurst	New South Wales
Australia	Premier Specialists	Kogarah	New South Wales
Australia	Novatrials	Kotara	New South Wales
Australia	Woden Dermatology	Phillip	Australian Capital Territory
Australia	Veracity Clinical Research	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Azora Therapeutics Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events		10 weeks