The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis (ARQ-151-201)
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| ClinicalTrials.gov Identifier: NCT03638258 |
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Recruitment Status :
Completed
First Posted : August 20, 2018
Results First Posted : August 10, 2022
Last Update Posted : September 2, 2022
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Sponsor:
Arcutis Biotherapeutics, Inc.
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.
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Brief Summary:
This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: Roflumilast Cream 0.3% Drug: Roflumilast Cream 0.15% Drug: Vehicle Cream | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 331 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Parallel group, double blind, vehicle-controlled study |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Roflumilast drug product will be supplied as a 0.3% and 0.15% cream. The matching vehicle cream will contain only excipients of roflumilast cream. |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2b 12-Week Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream 0.3% and ARQ-151 Cream 0.15% Administered Once Daily in Subjects With Chronic Plaque Psoriasis |
| Actual Study Start Date : | September 21, 2018 |
| Actual Primary Completion Date : | May 29, 2019 |
| Actual Study Completion Date : | May 29, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Psoriasis
Drug Information available for:
Roflumilast
| Arm | Intervention/treatment |
|---|---|
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Experimental: Roflumilast Cream 0.3%
Roflumilast cream 0.3% topically applied QD for 12 weeks.
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Drug: Roflumilast Cream 0.3%
Applied once daily for 12 weeks
Other Name: ARQ-151 |
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Experimental: Roflumilast Cream 0.15%
Roflumilast cream 0.15% topically applied QD for 12 weeks.
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Drug: Roflumilast Cream 0.15%
Applied once daily for 12 weeks
Other Name: ARQ-151 |
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Placebo Comparator: Vehicle Cream
Vehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.
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Drug: Vehicle Cream
Applied once daily for 12 weeks |
Primary Outcome Measures :
- Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6 [ Time Frame: Week 6 ]The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
Secondary Outcome Measures :
- Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' [ Time Frame: Weeks 4, 8, and 12 ]The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
- Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score [ Time Frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12 ]The percent change from baseline in mPASI score is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. For scoring, the body is divided into four sections (head [h]: 10% of a person's skin; arms [a] 20%; trunk [t] 30%; legs (l] 40%); for each section, the percent of area involved is estimated from 0 (0% involved) to 6 (90 to 100% involved). Then, within each area, the severity is estimated by three clinical signs: erythema ('E'; redness), induration ('T'; thickness), and desquamation ('S'; scaling). Severity parameters are measured on a scale of 0 to 4, from none to maximum severity possible. Each of these areas is scored by itself, and then the four scores are combined into the final mPASI, using the formula mPASI = 0.1 (Eh + Th + Sh) Ah + 0.2 (Ea + Ta + Sa) Aa + 0.3 (Et + Tt + St) At + 0.4 (El + Tl + Sl) Al.
- Percent Change From Baseline in Body Surface Area (BSA) Affected [ Time Frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12 ]The BSA affected by psoriasis was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. The mean percent change from baseline in BSA is presented.
- Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline [ Time Frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12 ]The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') plus a 2-grade improvement from baseline is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
- Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline [ Time Frame: Weeks 4, 6, 8, and 12 ]The percentage of participants (who had intertriginous area involvement with an I-IGA score of at least mild at baseline) with at least a 2-grade improvement in I-IGA score at Weeks 4, 6, 8, and 12 is presented.
- Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score [ Time Frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12 ]The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. The mean (SD) change in WI-NRS score from baseline is presented.
- Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction [ Time Frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12 ]The percentage of participants who had baseline WI-NRS scores ≥6 who achieved a 4-point reduction in WI-NRS score at Weeks 4, 6, 8, and 12 is reported. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours.
- Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline [ Time Frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12 ]The percentage of subjects achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.
- Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline [ Time Frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12 ]The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity. The percentage of subjects achieving a 90% reduction in mPASI (eg, mPASI-90) score relative to baseline is presented.
- Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score [ Time Frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12 ]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 11 ("worst imaginable symptoms"). Scores range from 0 to 176, with higher scores indicating greater symptom severity. The mean (SD) change in PSD total score relative to baseline is presented for each treatment arm.
- Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score [ Time Frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12 ]The Itch-Related Sleep Loss NRS is a single item scale scored from 0 ("no itch-related sleep loss") to 10 ("itch-related sleep loss as bad as it could be") assessing the severity of itch-related sleep loss in the past 24 hours. The mean (SD) change from the baseline NRS score is presented for each treatment arm.
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score [ Time Frame: Baseline (Day 1) and Weeks 4, 6, 8, and 12 ]The DLQI is a 10-item scale asking subject to rate the severity of symptoms during the past week. Each item is scored from 0 ("not at all" or "not relevant") to 3 or 4 ("very much") [2 questions are scored 0 to 3 and 8 questions are scored 0 to 4]. The total DLQI score ranges from 0 to 48, with higher scores indicating greater symptom severity. The mean (SD) change from baseline DLQI score is presented.
- Responses to Individual Questions of the Psoriasis Symptom Diary (PSD) [ Time Frame: Weeks 4, 6, 8, and 12 ]Two items from the PSD asking participants to rate the overall severity of psoriasis-related itching and pain during the past 24 hours are presented. Each item is scored on an 11-point scale ranging from 0 ("no symptom") to 10 ("worst imaginable symptom"), with lower scores indicating lower symptoms severity. The mean (SD) score is presented for each treatment arm.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants legally competent to sign and give informed consent
- Males and females ages 18 years and older (inclusive)
- Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
- Females of childbearing potential (FOCBP) must have a negative urine 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 are 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 or tanning bed.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Previous treatment with roflumilast cream 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 study medication.
- 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.
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): NCT03638258
Locations
Show 30 study locations
Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
Investigators
| Study Director: | David Berk, MD | Arcutis Biotherapeutics, Inc. |
Study Documents (Full-Text)
Documents provided by Arcutis Biotherapeutics, Inc.:
Documents provided by Arcutis Biotherapeutics, Inc.:
Study Protocol [PDF] November 12, 2018
Statistical Analysis Plan [PDF] May 30, 2019
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Arcutis Biotherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03638258 |
| Other Study ID Numbers: |
ARQ-151-201 |
| First Posted: | August 20, 2018 Key Record Dates |
| Results First Posted: | August 10, 2022 |
| Last Update Posted: | September 2, 2022 |
| Last Verified: | August 2022 |
| 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 |