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The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis (ARQ-151-201)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03638258
Recruitment Status : Completed
First Posted : August 20, 2018
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE August 16, 2018
First Posted Date  ICMJE August 20, 2018
Last Update Posted Date August 18, 2020
Actual Study Start Date  ICMJE September 21, 2018
Actual Primary Completion Date May 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
An Investigator Global Assessment (IGA) score of 'clear' or 'almost clear' [ Time Frame: Week 6 ]
Primary Efficacy Endpoint
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
An Investigator Global Assessment score of 'clear' or 'almost clear' [ Time Frame: Week 6 ]
Primary Efficacy Endpoint
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2018)
  • IGA score of 'clear' or 'almost clear' [ Time Frame: Weeks 4, 8 and 12 ]
  • Percent reduction in Modified Psoriasis Area Severity [ Time Frame: Weeks 4, 6, 8, and 12 ]
  • Decrease in percent body surface area affected [ Time Frame: Weeks 4, 6, 8, and 12 ]
  • IGA score of 'clear' or 'almost clear' plus a 2-grade improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • For subjects with intertriginous area involvement, and with severity of the intertriginous lesions at least 'mild' (intertriginous IGA (I-IGA) ≥2) at Baseline, 'I-IGA' score of 'clear' or 'almost clear' [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Reduction in Worst Itch-Numeric (WI-NRS) Rating Scale pruritus score [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • In subjects with WI-NRS pruritus score ≥ 6 at baseline, a 4-point reduction in WI-NRS pruritus score [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Modified Psoriasis Area Severity Index-75 (mPASI-75; subjects who achieve a 75% reduction in mPASI from Baseline) improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Modified Psoriasis Area Severity Index-90 (mPASI-90; subjects who achieve a 90% reduction in mPASI from Baseline) improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Psoriasis Symptom Diary (PSD) improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Reduction in Itch-related Sleep Loss NRS (Numeric Rating Scale) score [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Reduction in Dermatology Life Quality Index (DLQI) score [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Responses to the questions of PSD analyzed as improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • IGA score of 'clear' or 'almost clear' [ Time Frame: Weeks 4, 8 and 12 ]
  • Percent reduction in Modified Psoriasis Area Severity [ Time Frame: Weeks 4, 6, 8, and 12 ]
  • Decrease in percent body surface area affected [ Time Frame: Weeks 4, 6, 8, and 12 ]
  • IGA score of 'clear' or 'almost clear' plus a 2-grade improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • For subjects with intertriginous area involvement, and with severity of the intertriginous lesions at least 'mild' (intertriginous IGA (I-IGA) ≥2) at Baseline, 'I-IGA' score of 'clear' or 'almost clear' [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Reduction in WI-NRS pruritus score [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • In subjects with WI-NRS pruritus score ≥ 6 at baseline, a 4-point reduction in WI-NRS pruritus score [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Modified Psoriasis Area Severity Index-75 (mPASI-75; subjects who achieve a 75% reduction in mPASI from Baseline) improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Modified Psoriasis Area Severity Index-90 (mPASI-90; subjects who achieve a 90% reduction in mPASI from Baseline) improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • PSD improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
  • Reduction in Itch-related Sleep Loss score [ Time Frame: Weeks 4, 6, 8 and 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
Official Title  ICMJE A Phase 2b 12-Week Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream 0.3% and ARQ-151 Cream 0.15% Administered Once Daily in Subjects With Chronic Plaque Psoriasis
Brief Summary This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream 0.3% or ARQ-151 cream 0.15% or vehicle cream is applied once daily for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel group, double blind, vehicle-controlled study
Masking: Double (Participant, Investigator)
Masking Description:
ARQ-151 drug product will be supplied as a 0.3% and 0.15% cream. The matching vehicle cream will contain only excipients of ARQ-151 cream.
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: ARQ-151 Cream 0.3%
    Applied once daily for 12 weeks
  • Drug: ARQ-151 Cream 0.15%
    Applied once daily for 12 weeks
  • Drug: ARQ-151 vehicle cream
    Applied once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: ARQ-151 cream 0.3%
    ARQ-151 cream 0.3% topically applied once daily
    Intervention: Drug: ARQ-151 Cream 0.3%
  • Experimental: ARQ-151 cream 0.15%
    ARQ-151 cream 0.15% topically applied once daily
    Intervention: Drug: ARQ-151 Cream 0.15%
  • Placebo Comparator: ARQ-151 Vehicle cream
    Matching vehicle cream containing only excipients of ARQ-151 cream applied once daily
    Intervention: Drug: ARQ-151 vehicle cream
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2019)
331
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2018)
300
Actual Study Completion Date  ICMJE May 29, 2019
Actual Primary Completion Date May 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03638258
Other Study ID Numbers  ICMJE ARQ-151-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arcutis Biotherapeutics, Inc.
Study Sponsor  ICMJE Arcutis Biotherapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Howard Welgus, MD Arcutis Biotherapeutics, Inc.
PRS Account Arcutis Biotherapeutics, Inc.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP