The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

NCT03638258 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ARQ-151-201
• Study Type: interventional
• Target: 331
• Locations: 2 countries
• Sites: 30

Brief Summary

This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6

  The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.

  Week 6

Secondary Outcomes (13)

• Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'

  Weeks 4, 8, and 12

• Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score

  Baseline (Day 1) and Weeks 4, 6, 8, and 12

• Percent Change From Baseline in Body Surface Area (BSA) Affected

  Baseline (Day 1) and Weeks 4, 6, 8, and 12

• Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline

  Baseline (Day 1) and Weeks 4, 6, 8, and 12

• Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline

  Weeks 4, 6, 8, and 12

Study Arms (3)

Roflumilast Cream 0.3%

EXPERIMENTAL

Roflumilast cream 0.3% topically applied QD for 12 weeks.

Drug: Roflumilast Cream 0.3%

Roflumilast Cream 0.15%

EXPERIMENTAL

Roflumilast cream 0.15% topically applied QD for 12 weeks.

Drug: Roflumilast Cream 0.15%

Vehicle Cream

PLACEBO COMPARATOR

Vehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.

Drug: Vehicle Cream

Interventions

Roflumilast Cream 0.3% DRUG

Applied once daily for 12 weeks

Also known as: ARQ-151

Roflumilast Cream 0.3%

Roflumilast Cream 0.15% DRUG

Applied once daily for 12 weeks

Also known as: ARQ-151

Roflumilast Cream 0.15%

Vehicle Cream DRUG

Applied once daily for 12 weeks

Vehicle Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants legally competent to sign and give informed consent
• Males and females ages 18 years and older (inclusive)
• Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
• Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
• In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
• Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

You may not qualify if:

• Planned excessive exposure of treated area(s) to either natural or artificial sunlight or tanning bed.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Previous treatment with roflumilast cream or its active ingredient
• Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
• Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
• Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (30)

Arcutis Clinical Site 35

Beverly Hills, California, 90212, United States

Location

Arcutis Clinical Site 29

Northridge, California, 91324, United States

Location

Arcutis Clinical Site 28

San Diego, California, 92123, United States

Location

Arcutis Clinical Site 27

Santa Monica, California, 90403, United States

Location

Arcutis Clinical Site 12

Miami, Florida, 33144, United States

Location

Arcutis Clinical Site 16

Sanford, Florida, 32771, United States

Location

Arcutis Clinical Site 21

Louisville, Kentucky, 40217, United States

Location

Arcutis Clinical Site 34

Clinton Township, Michigan, 48038, United States

Location

Arcutis Clinical Site 33

Detroit, Michigan, 48202, United States

Location

Arcutis Clinical Site 20

Fridley, Minnesota, 55432, United States

Location

Arcutis Clinical Site 22

New York, New York, 10029, United States

Location

Arcutis Clinical Site 14

High Point, North Carolina, 27262, United States

Location

Arcutis Clinical Site 39

Bexley, Ohio, 43209, United States

Location

Arcutis Clinical Site 15

Pittsburgh, Pennsylvania, 15213, United States

Location

Arcutis Clinical Site 19

College Station, Texas, 77845, United States

Location

Arcutis Clinical Site 37

Houston, Texas, 77004, United States

Location

Arcutis Clinical Site 13

Houston, Texas, 77056, United States

Location

Arcutis Clinical Site 23

San Antonio, Texas, 78213, United States

Location

Arcutis Clinical Site 24

Webster, Texas, 77598, United States

Location

Arcutis Clinical Site 31

Norfolk, Virginia, 23502, United States

Location

Arcutis Clinical Site 18

Surrey, British Columbia, V3R 6A7, Canada

Location

Arcutis Clinical Site 11

Surrey, British Columbia, V3V 0C6, Canada

Location

Arcutis Clinical Site 38

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Arcutis Clinical Site 10

Ajax, Ontario, L1S 7K8, Canada

Location

Arcutis Clinical Site 25

London, Ontario, N6H 5L5, Canada

Location

Arcutis Clinical Site 26

Markham, Ontario, L3P 1X2, Canada

Location

Arcutis Clinical Site 32

Oakville, Ontario, L6J 7W5, Canada

Location

Arcutis Clinical Site 17

Peterborough, Ontario, K9J 5K2, Canada

Location

Arcutis Clinical Site 30

Waterloo, Ontario, N2J 1C4, Canada

Location

Arcutis Clinical Site 36

Windsor, Ontario, N8W 1E6, Canada

Location

Related Publications (2)

• Stein Gold L, Alonso-Llamazares J, Draelos ZD, Gooderham MJ, Kempers SE, Kircik LH, Lebwohl MG, Papp KA, Pariser DM, Toth DP, Yosipovitch G, Higham RC, Feng A, Berk DR. Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial. Am J Clin Dermatol. 2023 Mar;24(2):305-313. doi: 10.1007/s40257-022-00739-3. Epub 2022 Nov 12.

  PMID: 36370336 DERIVED

• Lebwohl MG, Papp KA, Stein Gold L, Gooderham MJ, Kircik LH, Draelos ZD, Kempers SE, Zirwas M, Smith K, Osborne DW, Trotman ML, Navale L, Merritt C, Berk DR, Welgus H; ARQ-151 201 Study Investigators. Trial of Roflumilast Cream for Chronic Plaque Psoriasis. N Engl J Med. 2020 Jul 16;383(3):229-239. doi: 10.1056/NEJMoa2000073.

  PMID: 32668113 DERIVED

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Roflumilast drug product will be supplied as a 0.3% and 0.15% cream. The matching vehicle cream will contain only excipients of roflumilast cream.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel group, double blind, vehicle-controlled study

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: September 21, 2018
• Primary Completion: May 29, 2019
• Study Completion: May 29, 2019
• Last Updated: September 2, 2022
• Results First Posted: August 10, 2022

Record last verified: 2022-08

Locations

US (20); CA (10)