Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (DERMIS-OLE)
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|ClinicalTrials.gov Identifier: NCT04286607|
Recruitment Status : Recruiting
First Posted : February 27, 2020
Last Update Posted : March 2, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Plaque Psoriasis||Drug: Topical roflumilast||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||285 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: ARQ-151 Cream 0.3%||
Drug: Topical roflumilast
Other Name: ARQ-151 Cream 0.3%
- Occurrence of treatment emergent AEs (TEAEs) [ Time Frame: 24 weeks ]The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs
- Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time. [ Time Frame: 24 weeks ]
- In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response). [ Time Frame: 24 weeks ]
- Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time [ Time Frame: 24 weeks ]
- Achievement of a 75% reduction in PASI over time [ Time Frame: 24 weeks ]
- Achievement of a 90% reduction in PASI over time [ Time Frame: 24 weeks ]
- Achievement of a 100% reduction in PASI over time [ Time Frame: 24 weeks ]
- Change in Worst Itch Numeric Rating Scale) WI-NRS score over time [ Time Frame: 24 weeks ]
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|Ages Eligible for Study:||2 Years to 11 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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:
- Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
- 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.
- 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.
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
|Contact: Arcutis Medical Informationfirstname.lastname@example.org|
|Study Director:||David Berk, MD||Arcutis Biotherapeutics, Inc.|
|Responsible Party:||Arcutis Biotherapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||February 27, 2020 Key Record Dates|
|Last Update Posted:||March 2, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Skin Diseases, Papulosquamous