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

NCT04989517 | Completed Phase 1

• 1 other identifier: HS01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events

  10 weeks

Study Arms (2)

AT193

EXPERIMENTAL

Topical applied daily

Drug: AT193

Placebo

PLACEBO COMPARATOR

Topical applied daily

Drug: AT193

Interventions

AT193 DRUG

Topical

AT193; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azora Therapeutics Australia Pty Ltd: lead

Study Sites (7)

Woden Dermatology

Phillip, Australian Capital Territory, 2606, Australia

Location

East Sydney Doctors

Darlinghurst, New South Wales, 2010, Australia

Location

Holdsworth House Medical Practice

Darlinghurst, New South Wales, 2010, Australia

Location

Premier Specialists

Kogarah, New South Wales, 2217, Australia

Location

Novatrials

Kotara, New South Wales, 2289, Australia

Location

Veracity Clinical Research

Woolloongabba, Queensland, 4102, Australia

Location

North Eastern Health Specialists

Campbelltown, South Australia, 5074, Australia

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: November 23, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7)