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

Sponsor

Azora Therapeutics Australia Pty Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04989517

Collaborator

(none)

Enrollment

Locations

Arms

6.7

Anticipated Duration (Months)

6.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa	Drug: AT193	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 23, 2021

Anticipated Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AT193 Topical applied daily	Drug: AT193 Topical
Placebo Comparator: Placebo Topical applied daily	Drug: AT193 Topical

Arm

Intervention/Treatment

Experimental: AT193

Topical applied daily

Drug: AT193

Topical

Placebo Comparator: Placebo

Topical applied daily

Drug: AT193

Topical

Outcome Measures

Primary Outcome Measures

Incidence of treatment-emergent adverse events [10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woden Dermatology	Phillip	Australian Capital Territory	Australia	2606
2	East Sydney Doctors	Darlinghurst	New South Wales	Australia	2010
3	Holdsworth House Medical Practice	Darlinghurst	New South Wales	Australia	2010
4	Premier Specialists	Kogarah	New South Wales	Australia	2217
5	Novatrials	Kotara	New South Wales	Australia	2289
6	Veracity Clinical Research	Woolloongabba	Queensland	Australia	4102
7	North Eastern Health Specialists	Campbelltown	South Australia	Australia	5074

Sponsors and Collaborators

Azora Therapeutics Australia Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Azora Therapeutics Australia Pty Ltd

ClinicalTrials.gov Identifier:

NCT04989517

Other Study ID Numbers:

HS01

First Posted:

Aug 4, 2021

Last Update Posted:

Apr 13, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hidradenitis Suppurativa

Hidradenitis

Study Results

No Results Posted as of Apr 13, 2022