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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04989517




Registration number
NCT04989517
Ethics application status
Date submitted
26/07/2021
Date registered
4/08/2021
Date last updated
15/03/2024

Titles & IDs
Public title
Study of Efficacy and Safety of Investigational Treatment in Patients With Hidradenitis Suppurativa
Scientific 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
Secondary ID [1] 0 0
HS01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AT193

Experimental: AT193 - Topical applied daily

Placebo comparator: Placebo - Topical applied daily


Treatment: Drugs: AT193
Topical
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events
Timepoint [1] 0 0
10 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2023
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [4] 0 0
Premier Specialists - Kogarah
Recruitment hospital [5] 0 0
Novatrials - Kotara
Recruitment hospital [6] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [7] 0 0
North Eastern Health Specialists - Campbelltown
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2289 - Kotara
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5074 - Campbelltown

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Azora Therapeutics Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04989517
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04989517