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

NCT ID: NCT04989517

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2023-03-15

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.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AT193

Topical applied daily

Group Type: EXPERIMENTAL

AT193

Intervention Type: DRUG

Topical

Placebo

Topical applied daily

Group Type: PLACEBO_COMPARATOR

AT193

Intervention Type: DRUG

Topical

Interventions

AT193

Topical

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azora Therapeutics Australia Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Woden Dermatology

Phillip, Australian Capital Territory, 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

Veracity Clinical Research

Woolloongabba, Queensland, Australia

North Eastern Health Specialists

Campbelltown, South Australia, Australia

Countries

Australia

Other Identifiers

HS01

Identifier Type: -

Identifier Source: org_study_id