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The trial is taking place at:
S

Sinclair Dermatology | East Melbourne, Australia

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

A

Azora Therapeutics

Status and phase

Active, not recruiting
Phase 1

Conditions

Plaque Psoriasis
Nail Psoriasis

Treatments

Drug: AT193

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

34 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

34 participants in 2 patient groups, including a placebo group

AT193
Experimental group
Description:
Topical applied daily
Treatment:
Drug: AT193
Placebo
Placebo Comparator group
Description:
Topical applied daily
Treatment:
Drug: AT193

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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