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Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (DERMIS-OLE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04286607
Recruitment Status : Recruiting
First Posted : February 27, 2020
Last Update Posted : March 2, 2023
Sponsor:
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.

Study Description
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Brief Summary:
This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: Topical roflumilast Phase 3

Detailed Description:
This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 285 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Subjects With Chronic Plaque Psoriasis
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Roflumilast

Arms and Interventions
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Arm Intervention/treatment
Experimental: ARQ-151 Cream 0.3% Drug: Topical roflumilast
Active treatment
Other Name: ARQ-151 Cream 0.3%


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of treatment emergent AEs (TEAEs) [ Time Frame: 24 weeks ]
    The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs


Secondary Outcome Measures :
  1. Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time. [ Time Frame: 24 weeks ]
  2. In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response). [ Time Frame: 24 weeks ]
  3. Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time [ Time Frame: 24 weeks ]
  4. Achievement of a 75% reduction in PASI over time [ Time Frame: 24 weeks ]
  5. Achievement of a 90% reduction in PASI over time [ Time Frame: 24 weeks ]
  6. Achievement of a 100% reduction in PASI over time [ Time Frame: 24 weeks ]
  7. Change in Worst Itch Numeric Rating Scale) WI-NRS score over time [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws
  • Males and females ages 2 years and older (inclusive)

  • Subjects with chronic plaque psoriasis who meet eligibility criteria and:

    1. Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
    2. Are naïve to treatment with ARQ-151 cream (Cohort 2)
  • Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.

Exclusion Criteria:

  • Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study.
  • 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.
  • 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.
Contacts and Locations
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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): NCT04286607


Contacts
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Contact: Arcutis Medical Information 1-844-692-6729 medinfo@arcutis.com

Locations
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Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
Investigators
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Study Director: David Berk, MD Arcutis Biotherapeutics, Inc.
More Information
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Responsible Party: Arcutis Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04286607    
Other Study ID Numbers: ARQ-151-306
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: March 2, 2023
Last Verified: February 2023

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