Phase 3
Completed N=442
Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Source: ClinicalTrials.gov NCT04211389 ↗Enrolled (actual)
442
Serious AEs
0.2%
Results posted
Oct 2022
Primary outcomePrimary: Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale — 99; 9 Participants — p=<0.0001
◆ Published Evidence
Highly cited
113citations · ~28 / year
Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials.
Summary
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
Linked Publications (3)
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Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials.
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Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies.
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Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale |
99; 9 | <0.0001 sig |
| SECONDARY Time to Achieve Psoriasis Area Severity Index-50 (PASI-50) |
30.0; NA | <0.0001 sig |
| SECONDARY Number of Participants Achieving Psoriasis Area Severity Index-75 (PASI-75) |
103; 7 | <0.0001 sig |
| SECONDARY Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90) |
45; 3 | 0.0002 sig |
| SECONDARY Number of Participants Achieving Success in Intertriginous Investigator Global Assessment (I-IGA) Scale Assessment of Disease Severity at Week 8 |
32; 5 | 0.0004 sig |
| SECONDARY Number of Participants Achieving I-IGA Score of 'Clear' at Week 8 |
27; 2 | 0.0002 sig |
| SECONDARY Number of Participants Achieving Success in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score |
90; 23; 120; 23; 143; 36 | 0.0026 sig |
| SECONDARY Change From Baseline in Psoriasis Symptoms Diary (PSD) Score |
-42.7; -16.7; -49.3; -22.8 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04211389) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.