MedDataX Logo

Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT ID: NCT04211389

Last Updated: 2022-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-17

Study Completion Date

2020-11-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03638258

Plaque Psoriasis
COMPLETED PHASE2

Study to Evaluate Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects

NCT03018509

Plaque Psoriasis Psoriasis Skin Diseases
COMPLETED PHASE1

Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

NCT05763082

Plaque Psoriasis
COMPLETED PHASE3

Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

NCT05028582

Scalp Psoriasis
COMPLETED PHASE3

Study to Investigate the Safety, Tolerability, Absorption, Distribution, Metabolism, and Elimination of RWJ-445380 Administered to Patients With Plaque Psoriasis

NCT00396422

Chronic Small Plaque Psoriasis
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily x 8 weeks to subjects with psoriasis

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Plaque Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARQ-151 cream 0.3%

Active comparator

Group Type ACTIVE_COMPARATOR

ARQ-151 0.3% cream

Intervention Type DRUG

ARQ-151 0.3% cream

ARQ-151 cream vehicle

Placebo comparator

Group Type PLACEBO_COMPARATOR

ARQ-151 vehicle cream

Intervention Type DRUG

ARQ-151 vehicle cream

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ARQ-151 0.3% cream

ARQ-151 0.3% cream

Intervention Type DRUG

ARQ-151 vehicle cream

ARQ-151 vehicle cream

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants legally competent to sign and give informed consented and if appropriate assent as required by local laws
* Males and females ages 2 years and older (inclusive)
* Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
* Females of childbearing potential (FOCBP) must have a negative 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 considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria

* Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.

* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
* Previous treatment with ARQ-151 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 investigational product
* 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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Arcutis Biotherapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Berk, MD

Role: STUDY_DIRECTOR

Arcutis Biotherapeutics, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arcutis Biotherapeutics Clinical Site 203

Scottsdale, Arizona, United States

Site Status

Arcutis Biotherapeutics Clinical Site 239

Beverly Hills, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 225

Encino, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 220

San Diego, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 208

Santa Monica, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 215

Santa Monica, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 223

Boynton Beach, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 237

DeLand, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 228

Largo, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 201

North Miami Beach, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 209

Sweetwater, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 214

Indianapolis, Indiana, United States

Site Status

Arcutis Biotherapeutics Clinical Site 217

Louisville, Kentucky, United States

Site Status

Arcutis Biotherapeutics Clinical Site 211

Lake Charles, Louisiana, United States

Site Status

Arcutis Biotherapeutics Clinical Site 213

Metairie, Louisiana, United States

Site Status

Arcutis Biotherapeutics Clinical Site 224

New Orleans, Louisiana, United States

Site Status

Arcutis Biotherapeutics Clinical Site 212

Detroit, Michigan, United States

Site Status

Arcutis Biotherapeutics Clinical Site 216

Fridley, Minnesota, United States

Site Status

Arcutis Biotherapeutics Clinical Site 227

Saint Joseph, Missouri, United States

Site Status

Arcutis Biotherapeutics Clinical Site 219

Las Vegas, Nevada, United States

Site Status

Arcutis Biotherapeutics Clinical Site 231

Las Vegas, Nevada, United States

Site Status

Arcutis Biotherapeutics Clinical Site 240

Reno, Nevada, United States

Site Status

Arcutis Biotherapeutics Clinical Site 236

Portsmouth, New Hampshire, United States

Site Status

Arcutis Biotherapeutics Clinical Site 222

Oklahoma City, Oklahoma, United States

Site Status

Arcutis Biotherapeutics Clinical Site 229

Broomall, Pennsylvania, United States

Site Status

Arcutis Biotherapeutics Clinical Site 233

Knoxville, Tennessee, United States

Site Status

Arcutis Biotherapeutics Clinical Site 221

Murfreesboro, Tennessee, United States

Site Status

Arcutis Biotherapeutics Clinical Site 206

Arlington, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 238

Houston, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 210

West Jordan, Utah, United States

Site Status

Arcutis Biotherapeutics Clinical Site 230

Richmond, Virginia, United States

Site Status

Arcutis Biotherapeutics Clinical Site 207

Surrey, British Columbia, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 226

Surrey, British Columbia, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 232

Winnepeg, Manitoba, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 234

Fredericton, New Brunswick, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 205

Ajax, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 218

Barrie, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 235

Toronto, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 204

Windsor, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

References

Explore related publications, articles, or registry entries linked to this study.

Papp KA, Del Rosso JQ, Lebwohl MG, Gooderham MJ, Hebert AA, Hong HC, Kircik LH, Pariser DM, Stein Gold L, Strober B, Seal MS, Krupa D, Chu DH, Burnett P, Berk DR, Higham RC. Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials. Dermatol Ther (Heidelb). 2025 Oct 24. doi: 10.1007/s13555-025-01562-4. Online ahead of print.

Reference Type DERIVED
PMID: 41134450 (View on PubMed)

Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24.

Reference Type DERIVED
PMID: 36422852 (View on PubMed)

Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.

Reference Type DERIVED
PMID: 36125472 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ARQ-151-302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis
NCT03358290 TERMINATED PHASE2
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
NCT03611751 COMPLETED PHASE3
Multi-Dose Study of SHR-1314 in Subjects With Moderate-to-severe Plaque Psoriasis
NCT03463187 COMPLETED PHASE1/PHASE2
Study to Evaluate Efficacy and Safety of MP1032 in Patients With Chronic Plaque Psoriasis
NCT03706209 COMPLETED PHASE2
A Phase 3 Study in Participants With Moderate to Severe Psoriasis
NCT01474512 COMPLETED PHASE3
A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis
NCT03759197 COMPLETED PHASE3
A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT03410992 COMPLETED PHASE3
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
NCT04908189 ACTIVE_NOT_RECRUITING PHASE3
Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy
NCT03721172 COMPLETED PHASE3
A Comparison of 188-0551 Solution Versus Vehicle Solution in Subjects With Plaque Psoriasis (Study 203)
NCT03065556 COMPLETED PHASE2
Apremilast Safety and PK Study in Recalcitrant Plaque Psoriasis
NCT00521339 COMPLETED PHASE2
A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is
NCT03835481 TERMINATED PHASE2
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT03412747 COMPLETED PHASE3
A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis
NCT01700985 COMPLETED PHASE2
A Double Blind Study in Pediatric Subjects With Chronic Plaque Psoriasis, Studying Adalimumab vs. Methotrexate
NCT01251614 COMPLETED PHASE3
Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307)
NCT03731052 COMPLETED PHASE3
A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis
NCT01634087 COMPLETED PHASE2
A Phase Ⅲ Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
NCT04839328 COMPLETED PHASE3
A Phase I Clinical Trial of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis
NCT07051538 COMPLETED PHASE1
Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis
NCT02201524 TERMINATED PHASE2
A Study to Evaluate the Effects of Efalizumab on Immune Responses in Subjects With Moderate Plaque Psoriasis
NCT00382512 COMPLETED PHASE1
A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis
NCT04911751 COMPLETED PHASE2
A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque Psoriasis
NCT00674063 COMPLETED PHASE3
Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT01483924 COMPLETED PHASE2
A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis
NCT06095115 ACTIVE_NOT_RECRUITING PHASE3