Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

Phase 3

Completed

Conditions: Chronic Plaque Psoriasis

Interventions: Drug: Roflumilast 0.3% cream
Drug: Vehicle Cream

Registration Number: NCT04211363

Lead Sponsor: Arcutis Biotherapeutics, Inc.

Brief Summary: This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 439

Inclusion Criteria

Participants legally competent to sign and give informed consent 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rofumilast Cream 0.3%	Roflumilast 0.3% cream	Participants receive roflumilast cream 0.3% once daily for 8 weeks.
Vehicle cream	Vehicle Cream	Participants receive vehicle cream once daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8	Baseline (Day 1) and Week 8	The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.

Secondary Outcome Measures

Name	Time	Method
Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)	From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 121 days)	The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The time to achieve PASI-50 (defined as a 50% reduction from baseline in PASI score) is presented, and is based on observed data only.
Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75)	Baseline (Day 1) and Week 8	The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-75 (defined as a 75% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)	Baseline (Day 1) and Week 8	Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) \[higher scores indicate greater symptom severity\]. The number of participants achieving PASI-90 (defined as a 90% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Number of Participants Achieving Intertriginous IGA (I-IGA) Success at Week 8	Baseline (Day 1) and Week 8	The number of participants achieving I-IGA success at Week 8 is presented. Success is defined as achievement of I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8 PLUS a ≥2-grade improvement in score from Baseline. The I-IGA is a 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater symptom severity. Participant counts are based on observed data only.
Number of Participants Achieving Score of 'Clear' in I-IGA at Week 8	Week 8	The number of participants achieving an IGA score of 0 ('clear') at Week 8 is presented (observed data only) for each arm. The I-IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'); higher scores indicate greater symptom severity.
Number of Participants Achieving Worst Itch Numerical Rating Score (WI-NRS) Success	Baseline (Day 1) and Weeks 2, 4, and 8	The number of participants achieving success in WI-NRS is presented. Success is defined as achievement of a ≥ 4-point reduction in WI-NRS pruritus score in participants with WI-NRS pruritus score ≥ 4 at baseline. The WI-NRS is a 10 point scale ranging from 0 ('no itch') to 10 ('worst itch imaginable'), with higher scores indicating greater symptoms severity. Results are based on observed data only.
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score	Weeks 4 and 8	The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The least squares (LS) mean (95% CI) change in PSD total score relative to baseline is presented for each treatment arm, with decreases from baseline indicating symptom improvement.

Trial Locations

Locations (40): Arcutis Biotherapeutics Clinical Site 127
🇺🇸
Encinitas, California, United States
Arcutis Biotherapeutics Clinical Site 112
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Fremont, California, United States
Arcutis Biotherapeutics Clinical Site 120
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Irvine, California, United States
Arcutis Biotherapeutics Clinical Site 123
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San Diego, California, United States
Arcutis Biotherapeutics Clinical Site 136
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San Francisco, California, United States
Arcutis Biotherapeutics Clinical Site 118
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Delray Beach, Florida, United States
Arcutis Biotherapeutics Clinical Site 131
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Miami, Florida, United States
Arcutis Biotherapeutics Clinical Site 137
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Ocala, Florida, United States
Arcutis Biotherapeutics Clinical Site 105
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Sanford, Florida, United States
Arcutis Biotherapeutics Clinical Site 114
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Plainfield, Illinois, United States
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Arcutis Biotherapeutics Clinical Site 127
🇺🇸Encinitas, California, United States