A Phase 3 interventional study of ARQ-151 0.3% cream and ARQ-151 vehicle cream in Chronic Plaque Psoriasis, sponsored by Arcutis Biotherapeutics, Inc.. Completed at 39 sites in 2 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Arcutis Biotherapeutics, Inc. · Phase 3, Interventional, and Treatment
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
This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily x 8 weeks to subjects with psoriasis
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 442 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Arcutis Biotherapeutics, Inc. is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Active comparator
Drug: ARQ-151 0.3% cream
Placebo comparator
Drug: ARQ-151 vehicle cream
ARQ-151 0.3% cream
ARQ-151 vehicle cream
Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented 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 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. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Time frame: Week 8
Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)
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. Participants are included whether they achieved PASI-50 or not.
Time frame: From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 124 days)
Number of Participants Achieving Psoriasis Area Severity Index-75 (PASI-75)
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.
Time frame: Baseline (Day 1) and Week 8
Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)
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-90 (defined as a 90% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Time frame: Baseline (Day 1) and Week 8
Number of Participants Achieving Success in Intertriginous Investigator Global Assessment (I-IGA) Scale Assessment of Disease Severity at Week 8
The number of participants with I-IGA score ≥2 at baseline 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 I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline I-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.
Time frame: Week 8
Number of Participants Achieving I-IGA Score of 'Clear' at 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 intertriginous area plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Time frame: Week 8
Number of Participants Achieving Success in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score
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') the participant experienced in the past 24 hours, with higher scores indicating greater symptoms severity. Results are based on observed data only.
Time frame: Baseline (Day 1) and Week 2, Week 4, Week 8
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
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.
Time frame: Baseline (Day 1) and Weeks 4 and 8
Adult participants with chronic plaque psoriasis were enrolled at 43 study sites in the United States and Canada.
| Milestone | Roflumilast Cream 0.3% | Vehicle Cream |
|---|---|---|
| Started | 290 | 152 |
| Completed | 264 | 131 |
| Not completed | 26 | 21 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Lost to follow-up | 15 | 7 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Withdrawal by subject | 10 | 11 |
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented 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 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. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
| Participants | Roflumilast Cream 0.3% | Vehicle Cream |
|---|---|---|
| Number of Participants Achieving Success on the Investigator Global Assessment (IGA) Scale | 99 | 9 |
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. Participants are included whether they achieved PASI-50 or not.
| days | Roflumilast Cream 0.3% | Vehicle Cream |
|---|---|---|
| Time to Achieve Psoriasis Area Severity Index-50 (PASI-50) | 30.0 (29.0 to 42.0) | NA (71.0 to NA) |
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.
| Participants | Roflumilast Cream 0.3% | Vehicle Cream |
|---|---|---|
| Number of Participants Achieving Psoriasis Area Severity Index-75 (PASI-75) | 103 | 7 |
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-90 (defined as a 90% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
| Participants | Roflumilast Cream 0.3% | Vehicle Cream |
|---|---|---|
| Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90) | 45 | 3 |
The number of participants with I-IGA score ≥2 at baseline 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 I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline I-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.
| Participants | Roflumilast Cream 0.3% | Vehicle Cream |
|---|---|---|
| Number of Participants Achieving Success in Intertriginous Investigator Global Assessment (I-IGA) Scale Assessment of Disease Severity at Week 8 | 32 | 5 |
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 intertriginous area plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
| Participants | Roflumilast Cream 0.3% | Vehicle Cream |
|---|---|---|
| Number of Participants Achieving I-IGA Score of 'Clear' at Week 8 | 27 | 2 |
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') the participant experienced in the past 24 hours, with higher scores indicating greater symptoms severity. Results are based on observed data only.
| Participants | Roflumilast Cream 0.3% | Vehicle Cream |
|---|---|---|
| Week 2 | 90 | 23 |
| Week 4 | 120 | 23 |
| Week 8 | 143 | 36 |
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.
| score on a scale | Roflumilast Cream 0.3% | Vehicle Cream |
|---|---|---|
| Week 4 | -42.7 (-47.7 to -37.7) | -16.7 (-22.8 to -10.6) |
| Week 8 | -49.3 (-54.8 to -43.7) | -22.8 (-29.6 to -16.0) |
Collected over Up to 124 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Roflumilast Cream 0.3% | 0/290 (0%) | 0/290 (0%) | 0/290 (0%) |
| Vehicle Cream | 0/152 (0%) | 1/152 (0.7%) | 0/152 (0%) |
| Event | Roflumilast Cream 0.3% | Vehicle Cream |
|---|---|---|
| Cervical radiculopathyNervous system disorders | 0/290 | 1/152 |
| Age, Continuous(years) | Roflumilast Cream 0.3% | Vehicle Cream | Total |
|---|---|---|---|
| Mean | 46.9 ± 15.07 | 47.1 ± 14.07 | 47.0 ± 14.72 |
| Sex: Female, Male(Participants) | Roflumilast Cream 0.3% | Vehicle Cream | Total |
|---|---|---|---|
| Female | 114 | 52 | 166 |
| Male | 176 | 100 | 276 |
| Ethnicity (NIH/OMB)(Participants) | Roflumilast Cream 0.3% | Vehicle Cream | Total |
|---|---|---|---|
| Hispanic or Latino | 76 | 50 | 126 |
| Not Hispanic or Latino | 213 | 102 | 315 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Roflumilast Cream 0.3% | Vehicle Cream | Total |
|---|---|---|---|
| American-Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 20 | 9 | 29 |
| Black or African American | 13 | 9 | 22 |
| Native Hawaiian or Other Pacific Islander | 3 | 1 | 4 |
| White | 240 | 126 | 366 |
| Not Reported | 5 | 2 | 7 |
| Other | 8 | 4 | 12 |
| More than 1 Race | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Roflumilast Cream 0.3% | Vehicle Cream | Total |
|---|---|---|---|
| Hispanic or Latino | 76 | 50 | 126 |
| Not Hispanic or Latino | 213 | 102 | 315 |
| Not Reported | 1 | 0 | 1 |
| Investigator Global Assessment (IGA) Scores at Baseline(Participants) | Roflumilast Cream 0.3% | Vehicle Cream | Total |
|---|---|---|---|
| 0 - Clear | 0 | 0 | 0 |
| 1 - Almost Clear | 0 | 0 | 0 |
| 2 - Mild | 50 | 24 | 74 |
| 3 - Moderate | 220 | 118 | 338 |
| 4 - Severe | 20 | 10 | 30 |
| Psoriasis Area Severity Index (PASI) Score(score on a scale) | Roflumilast Cream 0.3% | Vehicle Cream | Total |
|---|---|---|---|
| Mean | 6.5 ± 3.22 | 7.0 ± 3.52 | 6.7 ± 3.33 |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score(units on a scale) | Roflumilast Cream 0.3% | Vehicle Cream | Total |
|---|---|---|---|
| Mean | 5.8 ± 2.61 | 6.1 ± 2.75 | 5.9 ± 2.66 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Arcutis Biotherapeutics, Inc.