Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    arq-151 | psoriasis

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 : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Arcutis, Inc.

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: ARQ-151 Cream 0.3% Drug: ARQ-151 Cream 0.15% Drug: ARQ-151 vehicle cream Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
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
Official Title: 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
Actual Study Start Date : September 21, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : July 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: ARQ-151 cream 0.3%
ARQ-151 cream 0.3% topically applied once daily
Drug: ARQ-151 Cream 0.3%
Applied once daily for 12 weeks

Experimental: ARQ-151 cream 0.15%
ARQ-151 cream 0.15% topically applied once daily
Drug: ARQ-151 Cream 0.15%
Applied once daily for 12 weeks

Placebo Comparator: ARQ-151 Vehicle cream
Matching vehicle cream containing only excipients of ARQ-151 cream applied once daily
Drug: ARQ-151 vehicle cream
Applied once daily for 12 weeks




Primary Outcome Measures :
  1. An Investigator Global Assessment (IGA) score of 'clear' or 'almost clear' [ Time Frame: Week 6 ]
    Primary Efficacy Endpoint


Secondary Outcome Measures :
  1. IGA score of 'clear' or 'almost clear' [ Time Frame: Weeks 4, 8 and 12 ]
  2. Percent reduction in Modified Psoriasis Area Severity [ Time Frame: Weeks 4, 6, 8, and 12 ]
  3. Decrease in percent body surface area affected [ Time Frame: Weeks 4, 6, 8, and 12 ]
  4. IGA score of 'clear' or 'almost clear' plus a 2-grade improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
  5. 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 ]
  6. Reduction in Worst Itch-Numeric (WI-NRS) Rating Scale pruritus score [ Time Frame: Weeks 4, 6, 8 and 12 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Psoriasis Symptom Diary (PSD) improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]
  11. Reduction in Itch-related Sleep Loss NRS (Numeric Rating Scale) score [ Time Frame: Weeks 4, 6, 8 and 12 ]
  12. Reduction in Dermatology Life Quality Index (DLQI) score [ Time Frame: Weeks 4, 6, 8 and 12 ]
  13. Responses to the questions of PSD analyzed as improvement [ Time Frame: Weeks 4, 6, 8 and 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638258


  Show 30 Study Locations
Sponsors and Collaborators
Arcutis, Inc.
Investigators
Layout table for investigator information
Study Director: Howard Welgus, MD Arcutis, Inc.

Layout table for additonal information
Responsible Party: Arcutis, Inc.
ClinicalTrials.gov Identifier: NCT03638258     History of Changes
Other Study ID Numbers: ARQ-151-201
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases