NCT03916081

Brief Summary

The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2019

Shorter than P25 for phase_2

Geographic Reach
2 countries

20 active sites

Status
completed

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

April 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2019

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

February 13, 2023

Completed
Last Updated

February 13, 2023

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

April 10, 2019

Results QC Date

November 29, 2022

Last Update Submit

January 13, 2023

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4

    The least squares (LS) mean (SD) change from baseline in EASI Total Score at Week 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

    Baseline and Week 4

Secondary Outcomes (9)

  • Percentage Change From Baseline in EASI Total Score

    Baseline and Weeks 1, 2, and 4

  • Mean Change From Baseline in EASI Total Score at Weeks 1 and 2

    Baseline and Weeks 1 and 2

  • Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50)

    Baseline and Weeks 1, 2, and 4

  • Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)

    Baseline and Weeks 1, 2, and 4

  • Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90)

    Baseline and Weeks 1, 2, and 4

  • +4 more secondary outcomes

Study Arms (3)

Roflumilast Cream 0.05%

ACTIVE COMPARATOR

Participants apply roflumilast cream 0.05% QD for 28 days.

Drug: Roflumilast Cream 0.05%

Roflumilast Cream 0.15%

ACTIVE COMPARATOR

Participants apply roflumilast cream 0.15% QD for 28 days.

Drug: Roflumilast Cream 0.15%

Vehicle Cream

PLACEBO COMPARATOR

Participants apply vehicle cream QD for 28 days.

Drug: Vehicle Cream

Interventions

Roflumilast Cream 0.05%DRUG

Roflumilast 0.05% cream for topical application

Also known as: ARQ-151
Roflumilast Cream 0.05%
Roflumilast Cream 0.15%DRUG

Roflumilast 0.15% cream for topical application

Also known as: ARQ-151
Roflumilast Cream 0.15%
Vehicle CreamDRUG

Inactive vehicle cream matched to roflumilast cream for topical application.

Vehicle Cream

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants legally competent to sign and give informed consent or, in the case of adolescents, assent with consent of a parent(s) or legal guardian, as required by local laws.
  • Males and females ages 12 years and older (inclusive) at the time of consent.
  • Clinical diagnosis of active atopic dermatitis for at least 6 months.
  • BSA (Body Surface Area) involvement of at least 2% but no more than 25% at Baseline.
  • vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild' ('2') or 'moderate ('3') at Baseline.
  • EASI (Eczema Area and Severity Index) score of ≥ 5 at Baseline.
  • Females of childbearing potential must have a negative serum pregnancy test at Screening and, if sexually active, agree to use birth control throughout the trial.
  • In good health as judged by the Investigator, based on medical history, physical examination, and clinical tests.

You may not qualify if:

  • Subjects with any serious medical condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
  • Evidence of skin conditions other than AD (atopic dermatitis) that would interfere with evaluation of the effect of the study medication.
  • Pregnant or lactating women or women planning to become pregnant during the study.
  • Known allergies to excipients in ARQ-151 cream.
  • Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors .
  • Subjects who are unwilling to refrain from using a tanning bed as well as outdoor tanning or excessive sun exposure.
  • Subjects with unstable AD or who cannot discontinue systemic and/or topical therapies for the treatment of AD.
  • Known or suspected:
  • severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C)
  • history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
  • within last 5 years, a history of severe depression, suicidal ideation
  • Previous treatment with ARQ-151.
  • Subjects with a history of chronic alcohol or drug abuse in past 6 months.
  • Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
  • Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Arcutis Clinical Site 25

Scottsdale, Arizona, 85254, United States

Location

Arcutis Clinical Site 01

San Diego, California, 92123, United States

Location

Arcutis Clinical Site 19

Hialeah, Florida, 33016, United States

Location

Arcutis Clinical Site 18

Miami, Florida, 33174, United States

Location

Arcutis Clinical Site 17

Sanford, Florida, 32771, United States

Location

Arcutis Clinical Site 16

Boise, Idaho, 83713, United States

Location

Arcutis Clinical Site 12

Indianapolis, Indiana, 46250, United States

Location

Arcutis Clinical Site 13

Plainfield, Indiana, 46168, United States

Location

Arcutis Clinical Site 15

Metairie, Louisiana, 70006, United States

Location

Arcutis Clinical Site 03

Fridley, Minnesota, 55432, United States

Location

Arcutis Clinical Site 02

High Point, North Carolina, 27262, United States

Location

Arcutis Clinical Site 08

Bexley, Ohio, 43209, United States

Location

Arcutis Clinical Site 23

Pittsburgh, Pennsylvania, 15213, United States

Location

Arcutis Clinical Site 20

Murfreesboro, Tennessee, 37130, United States

Location

Arcutis Clinical Site 09

College Station, Texas, 77845, United States

Location

Arcutis Clinical Site 04

San Antonio, Texas, 78213, United States

Location

Arcutis Clinical Site 21

Richmond, Virginia, 23224, United States

Location

Arcutis Clinical Site 14

Cobourg, Ontario, K9A 4J9, Canada

Location

Arcutis Clinical Site 10

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Arcutis Clinical Site 06

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Arcutis Medical Information
Organization
Arcutis Biotherapeutics
medinfo@arcutis.com
+1 (844) 692-6729

Study Officials

  • David Berk, MD

    Arcutis Biotherapeutics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
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

April 10, 2019

First Posted

April 16, 2019

Study Start

May 31, 2019

Primary Completion

November 4, 2019

Study Completion

November 4, 2019

Last Updated

February 13, 2023

Results First Posted

February 13, 2023

Record last verified: 2022-08

Locations

US(17)CA(3)