NCT05072886

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

September 29, 2021

Last Update Submit

January 23, 2023

Conditions

Nail PsoriasisPlaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events

    16 weeks

Study Arms (2)

AT193

EXPERIMENTAL

Topical applied daily

Drug: AT193

Placebo

PLACEBO COMPARATOR

Topical applied daily

Drug: AT193

Interventions

AT193DRUG

Topical applied to affected areas daily

AT193Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinclair Dermatology

East Melbourne, Victoria, 3002, Australia

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 11, 2021

Study Start

April 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

AU(1)