Hidradenitis Suppurativa
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Hidradenitis Suppurativa
HS01 Enrolling

Hidradenitis Suppurativa Research Trial (15 Weeks)


Age: 18 Years

Adults aged 18 to 80 with hidradenitis suppurativa (HS), may qualify for this research trial. Individuals must have a diagnosis or signs and symptoms consistent with HS for at least 3 months. Patients must have mild to moderate HS with a minimum of two active abscesses or inflammatory nodule (AN) count. Stable disease for at least 2 months before screening, is also required.

Participants will receive investigational topical medication (active study drug) or placebo, as an ointment. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation will last about 15 weeks and involve about 5 visits to the study centre, plus 1 telephone visit.


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

ClinicalTrials.gov ID

NCT04989517

Sponsor

Azora Therapeutics Australia Pty Ltd

Study Description

  • Brief Summary:

    Azora Therapeutics Australia Pty Ltd

  • Condition or Disease:

    Hidradenitis Suppurativa

  • Intervention/Treatment:

    Drug: AT193 Drug: AT193
  • Phase:

    Phase 1

  • Ages Eligible for Study:

    18 Years and 80 Years (Adult,Older Adult)

  • Sexes Eligible for Study:

    All

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.


Participating Locations

COUNTRY
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Australia

Participating Experts

Dr. Shireen Sidhu

Dermatologist

Dr. Lynda Spelman

Dermatologist

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