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Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis

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: NCT05072886
Recruitment Status : Recruiting
First Posted : October 11, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Azora Therapeutics Inc. ( Azora Therapeutics Australia Pty Ltd )

Brief Summary:
Part 1 is a randomized, double-blind, placebo-controlled phase 1b study to evaluate AT193 in approximately 34 patients with nail psoriasis for 16 weeks. Part 2 is an open-label extension phase where all patients will receive active drug for an additional 16 weeks followed by a 2 week nontreatment period.

Condition or disease Intervention/treatment Phase
Nail Psoriasis Plaque Psoriasis Drug: AT193 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 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 Followed by an Open-Label Extension to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Topical AT193 in the Treatment of Patients With Nail Psoriasis
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: AT193
Topical applied daily
Drug: AT193
Topical

Placebo Comparator: Placebo
Topical applied daily
Drug: AT193
Topical




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of nail psoriasis for at least 3 months preceding study entry
  • Diagnosis or history of plaque psoriasis or psoriatic arthritis
  • A female participant of childbearing potential must use appropriate contraceptive measures during the study period
  • A female participant 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
  • Diagnosis of other active skin or nail diseases or skin or nail infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis
  • History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05072886


Contacts
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Contact: Matt Davidson, PhD 818-267-6726 matt@azoratherapeutics.com

Locations
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Australia, Victoria
Sinclair Dermatology Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Bevin Bhoyrul, MD         
Sponsors and Collaborators
Azora Therapeutics Australia Pty Ltd
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Responsible Party: Azora Therapeutics Australia Pty Ltd
ClinicalTrials.gov Identifier: NCT05072886    
Other Study ID Numbers: NP01
First Posted: October 11, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases