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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04989517
Recruitment Status : Recruiting
First Posted : August 4, 2021
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Azora Therapeutics Inc. ( Azora Therapeutics Australia Pty Ltd )

Tracking Information
First Submitted Date  ICMJE July 26, 2021
First Posted Date  ICMJE August 4, 2021
Last Update Posted Date April 13, 2022
Actual Study Start Date  ICMJE November 23, 2021
Estimated Primary Completion Date June 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2021)
Incidence of treatment-emergent adverse events [ Time Frame: 10 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy and Safety of Investigational Treatment in Patients With Hidradenitis Suppurativa
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE Drug: AT193
Topical
Study Arms  ICMJE
  • Experimental: AT193
    Topical applied daily
    Intervention: Drug: AT193
  • Placebo Comparator: Placebo
    Topical applied daily
    Intervention: Drug: AT193
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2021)
44
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2021)
40
Estimated Study Completion Date  ICMJE June 15, 2022
Estimated Primary Completion Date June 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matt Davidson, PhD 818-276-6726 matt@azoratherapeutics.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04989517
Other Study ID Numbers  ICMJE HS01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Azora Therapeutics Inc. ( Azora Therapeutics Australia Pty Ltd )
Study Sponsor  ICMJE Azora Therapeutics Australia Pty Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azora Therapeutics Inc.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP