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Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Adolescents and Adults With Chronic Plaque Psoriasis

NCT04279119 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-08-03

No results posted yet for this study

Summary

This is a phase 1, open label, single arm study in which ARQ-151 cream 0.3% is applied QD for 2 weeks to adolescent subjects with chronic plaque psoriasis involving at least 10% body surface area (BSA) and adult subjects with chronic plaque psoriasis involving at least 20% BSA (excluding scalp).

The objectives of this study are to evaluate the exposure and characterize the plasma pharmacokinetic profile and to assess the safety and tolerability of ARQ-151 cream 0.3% administered once daily for 2 weeks to adolescent and adult subjects with chronic plaque psoriasis.

Conditions

Interventions

DRUG

ARQ-151- cream 0.3%

ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 2 weeks

Sponsors & Collaborators

  • Arcutis Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Berk, MD · Arcutis Biotherapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2021-03-25
Completion
2021-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04279119 on ClinicalTrials.gov