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CompletedNCT03392168Updated Aug 4, 2022Results posted

Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis

A Phase 1/2 interventional study of ARQ-151 cream 0.5% and ARQ-151 cream 0.15% in Psoriasis, sponsored by Arcutis Biotherapeutics, Inc.. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Arcutis Biotherapeutics, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study assessed the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s) (Cohort 1). The study also assessed the safety, PK and efficacy of ARQ-151 cream 0.5% vs vehicle and ARQ-151 cream 0.15% vs vehicle applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).

Read the detailed description

There were 2 cohorts of participants. Cohort 1 was a single dose study of ARQ-151 0.5% cream applied to 25 cm\^2 of psoriatic plaque(s) in 8 psoriasis participants. Cohort 2 was a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream was applied once a day for 28 days to participants with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Participants were adult (≥18 years old) males or females with chronic plaque psoriasis.

02

Conditions studied

  • Psoriasis

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Keywords

  • Psoriasis
  • Plaque Psoriasis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult male and female participants aged ≥18 years.
  • In Cohort 1, participants must have at least 25 cm\^2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).
  • In Cohort 2, participants must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm\^2 in size with a TPSS ≥4 (excluding the face, scalp, intertriginous areas, palms and soles).
  • Women of childbearing potential must have a negative urine pregnancy test at Screening and agree to use birth control throughout the trial.
  • In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.
  • Participants agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.
  • Participants are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.

Exclusion criteria

Exclusion Criteria:

  • Participants with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis.
  • Evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication.
  • Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication.
  • Known allergies to excipients in ARQ-151 cream.
  • Participants who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period.
  • Participants who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.
  • Participants who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.
  • Participants with a history of chronic alcohol or drug abuse in past 6 months.
  • History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.
  • Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
  • Participants with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
  • Participants who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
91 participants (actual)

Study arms

  • Experimental
    Cohort 1 - ARQ-151 cream 0.5%

    Single-dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s)

    Drug: ARQ-151 cream 0.5%

  • Experimental
    Cohort 2 - ARQ-151 cream 0.5%

    ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA

    Drug: ARQ-151 cream 0.5%

  • Experimental
    Cohort 2 - ARQ-151 cream 0.15%

    ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA

    Drug: ARQ-151 cream 0.15%

  • Placebo comparator
    Cohort 2 - ARQ-151 vehicle cream

    Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA

    Drug: ARQ-151 vehicle cream

Interventions

  • DrugARQ-151 cream 0.5%

    0.5% active concentration

  • DrugARQ-151 cream 0.15%

    0.15% active concentration

  • DrugARQ-151 vehicle cream

    Vehicle cream

05

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in 4 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2

    Difference in least squares mean percent change from baseline at Week 4 in the product of target plaque severity score (TPSS) x target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS x TPA score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. TPA (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.

    Time frame: Baseline and Week 4

Secondary outcomes

  1. Percent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2

    Difference in least squares mean percent change from baseline at Weeks 1, 2 and 3 in target plaque severity score (TPSS) x target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS x TPA score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. TPA (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.

    Time frame: Baseline and Weeks 1, 2 and 3

  2. Percent Change From Baseline in Total Plaque Severity Score in Cohort 2

    Difference in least squares mean percent change from baseline at Weeks 1, 2, 3 and 4 in total plaque severity score (TPSS) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. A negative percent change indicates improvement.

    Time frame: Baseline and Weeks 1, 2, 3, and 4

  3. Percent Change From Baseline in Target Plaque Area in Cohort 2

    Difference in least squares mean percent change from baseline at Weeks 1, 2, 3, and 4 in target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPA score as a covariate. Target plaque area (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.

    Time frame: Baseline and Weeks 1, 2, 3, and 4

06

Results

Posted Jul 8, 2021

Participant flow

The study was conducted in 7 centers in Canada and 1 center in the United States (US). There was a total of 91 unique participants; 6 participants who completed Cohort 1 also participated in Cohort 2, with 2 per treatment group.

Period 1: Cohort 1
Participant flow — Period 1: Cohort 1
MilestoneCohort 1 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle Cream
Started8000
Completed8000
Not completed0000
Period 2: Cohort 2
Participant flow — Period 2: Cohort 2
MilestoneCohort 1 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle Cream
Started0302831
Completed0282730
Not completed0211
Withdrew: Lost to follow-up0111
Withdrew: Other0100

Outcome measures

PrimaryPercent Change From Baseline in 4 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2

Difference in least squares mean percent change from baseline at Week 4 in the product of target plaque severity score (TPSS) x target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS x TPA score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. TPA (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.

Time frame:
Baseline and Week 4
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in 4 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2
Percent changeCohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle Cream
Percent Change From Baseline in 4 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2-66.6 ± 7.27-66.0 ± 7.61-38.1 ± 7.34
Statistical analysis
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0007 · Least squares mean difference: -28.5 · 95% CI -44.6 to -12.4
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0011 · Least squares mean difference: -27.8 · 95% CI -44.2 to -11.5
SecondaryPercent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2

Difference in least squares mean percent change from baseline at Weeks 1, 2 and 3 in target plaque severity score (TPSS) x target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS x TPA score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. TPA (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.

Time frame:
Baseline and Weeks 1, 2 and 3
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2
Percent changeCohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle Cream
Week 1-34.7 ± 5.79-36.4 ± 6.16-31.5 ± 5.99
Week 2-48.7 ± 6.40-50.1 ± 6.75-30.4 ± 6.55
Week 3-61.5 ± 6.69-55.6 ± 7.03-32.6 ± 6.81
Statistical analysis
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.5493 · Least squares mean difference: -3.2 · 95% CI -13.7 to 7.3
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.3650 · Least squares mean difference: -4.9 · 95% CI -15.7 to 5.9
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0064 · Least squares mean difference: -18.3 · 95% CI -31.3 to -5.3
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0039 · Least squares mean difference: -19.8 · 95% CI -33.0 to -6.5
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0001 · Least squares mean difference: -28.9 · 95% CI -42.9 to -14.8
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0019 · Least squares mean difference: -23.0 · 95% CI -37.3 to -8.7
SecondaryPercent Change From Baseline in Total Plaque Severity Score in Cohort 2

Difference in least squares mean percent change from baseline at Weeks 1, 2, 3 and 4 in total plaque severity score (TPSS) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. A negative percent change indicates improvement.

Time frame:
Baseline and Weeks 1, 2, 3, and 4
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Total Plaque Severity Score in Cohort 2
Percent changeCohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle Cream
Week 1-30.5 ± 4.96-34.3 ± 5.20-26.2 ± 5.16
Week 2-41.9 ± 5.01-45.6 ± 5.22-26.4 ± 5.19
Week 3-51.5 ± 5.46-52.0 ± 5.63-30.1 ± 5.56
Week 4-55.1 ± 5.41-58.2 ± 5.56-36.5 ± 5.50
Statistical analysis
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.3626 · Least squares mean difference: -4.3 · 95% CI -13.6 to 5.0
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.1011 · Least squares mean difference: -8.1 · 95% CI -17.8 to 1.6
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0017 · Least squares mean difference: -15.5 · 95% CI -25.1 to -6.0
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0002 · Least squares mean difference: -19.3 · 95% CI -29.1 to -9.4
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0003 · Least squares mean difference: -21.3 · 95% CI -32.4 to -10.2
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0003 · Least squares mean difference: -21.8 · 95% CI -33.2 to -10.4
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0010 · Least squares mean difference: -18.7 · 95% CI -29.5 to -7.8
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0002 · Least squares mean difference: -21.8 · 95% CI -32.9 to -10.6
SecondaryPercent Change From Baseline in Target Plaque Area in Cohort 2

Difference in least squares mean percent change from baseline at Weeks 1, 2, 3, and 4 in target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPA score as a covariate. Target plaque area (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.

Time frame:
Baseline and Weeks 1, 2, 3, and 4
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Target Plaque Area in Cohort 2
Percent changeCohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle Cream
Week 1-9.15 ± 2.981-8.22 ± 3.198-11.82 ± 3.089
Week 2-14.95 ± 4.211-16.19 ± 4.407-10.37 ± 4.225
Week 3-22.63 ± 4.666-17.00 ± 4.844-9.95 ± 4.636
Week 4-31.87 ± 6.014-28.28 ± 6.228-11.61 ± 5.938
Statistical analysis
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.3209 · Least squares mean difference: 2.67 · 95% CI -2.65 to 7.99
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.1947 · Least squares mean difference: 3.60 · 95% CI -1.88 to 9.08
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.3561 · Least squares mean difference: -4.58 · 95% CI -14.40 to 5.24
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.2490 · Least squares mean difference: -5.82 · 95% CI -15.79 to 4.16
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0276 · Least squares mean difference: -12.68 · 95% CI -23.992 to -1.44
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.2223 · Least squares mean difference: -7.04 · 95% CI -18.44 to 4.36
  • Cohort 2 - ARQ-151 Cream 0.5% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0108 · Least squares mean difference: -20.27 · 95% CI -35.72 to -4.82
  • Cohort 2 - ARQ-151 Cream 0.15% vs Cohort 2 - ARQ-151 Vehicle Cream · Mixed Models Analysis · p = 0.0372 · Least squares mean difference: -16.67 · 95% CI -32.34 to -1.01

Adverse events

Collected over Up to approximately 5 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1 - ARQ-151 Cream 0.5%0/8 (0%)0/8 (0%)1/8 (12.5%)
Cohort 2 - ARQ-151 Cream 0.5%0/30 (0%)0/30 (0%)9/30 (30%)
Cohort 2 - ARQ-151 Cream 0.15%0/28 (0%)0/28 (0%)5/28 (17.9%)
Cohort 2 - ARQ-151 Vehicle Cream0/31 (0%)0/31 (0%)11/31 (35.5%)
Most frequent other events
Most frequent other events
EventCohort 1 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle Cream
Application site painGeneral disorders0/82/301/285/31
Application site erythemaGeneral disorders0/84/301/284/31
CandiduriaInfections and infestations1/80/300/280/31
NasopharyngitisInfections and infestations0/82/302/280/31
InfluenzaInfections and infestations0/80/300/282/31
Muscle strainInjury, poisoning and procedural complications0/81/301/282/31

Baseline characteristics

Baseline characteristics for Cohort 2 arms are shown for participants who were not in Cohort 1.

Age, Continuous
Age, Continuous(Years)Cohort 1 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle CreamTotal
Mean51.6 ± 16.9250.8 ± 15.7654.8 ± 13.5047.0 ± 13.9750.80 ± 14.75
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle CreamTotal
Female71271238
Male116191753
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle CreamTotal
Hispanic or Latino01001
Not Hispanic or Latino827262990
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.5%Cohort 2 - ARQ-151 Cream 0.15%Cohort 2 - ARQ-151 Vehicle CreamTotal
American Indian or Alaska Native00000
Asian022812
Native Hawaiian or Other Pacific Islander00000
Black or African American02204
White823222073
More than one race00000
Unknown or Not Reported01012
07

Study locations

8 sites
  • Mosaic Dermatology
    Santa Monica, California 90403, United States
  • Dr. Chih-ho Hong Medical Inc.
    Surrey, British Columbia V3R 6A7, Canada
  • Lynderm Research Inc.
    Markham, Ontario L3P 1X2, Canada
  • Research by ICLS
    Oakville, Ontario L6J 7W5, Canada
  • SKiN Centre for Dermatology
    Peterborough, Ontario K9J 5K2, Canada
  • The Centre for Dermatology
    Richmond Hill, Ontario L4B 1A5, Canada
  • K. Papp Clinical Research Inc.
    Waterloo, Ontario N2J 1C4, Canada
  • XLR8 Medical Research Inc.
    Windsor, Ontario N8W 1E6, Canada
08

References and documents

Publications

  • Papp KA, Gooderham M, Droege M, Merritt C, Osborne DW, Berk DR, Thurston AW, Smith VH, Welgus H. Roflumilast Cream Improves Signs and Symptoms of Plaque Psoriasis: Results from a Phase 1/2a Randomized, Controlled Study. J Drugs Dermatol. 2020 Aug 1;19(8):734-740. doi: 10.36849/JDD.2020.5370. PubMed 32845114 ↗

Study documents

  • Study protocol · Mar 19, 2018
  • Statistical analysis plan · May 6, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03392168
Lead sponsor
Arcutis Biotherapeutics, Inc.
Responsible party
Sponsor
First posted
Jan 5, 2018
Start date
Dec 11, 2017
Primary completion
May 2, 2018
Completion
May 2, 2018
Results posted
Jul 8, 2021
Last update
Aug 4, 2022

Study contacts

David Berk, M.D.
study director · Arcutis Biotherapeutics, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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