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Plaque PsoriasisPhase 2ARQ-151-201NCT03638258

The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

A Phase 2 study testing Roflumilast Cream 0.3% and Roflumilast Cream 0.15% in people with Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
Roflumilast Cream 0.3% and Roflumilast Cream 0.15%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
331 participants
Where
30 sitesin 2 countries
Study dates
21 Sep 2018to 29 May 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States20 sites

  • Arcutis Clinical Site 35

    Beverly Hills, California, 90212

  • Arcutis Clinical Site 39

    Bexley, Ohio, 43209

  • Arcutis Clinical Site 34

    Clinton Township, Michigan, 48038

  • Arcutis Clinical Site 19

    College Station, Texas, 77845

  • Arcutis Clinical Site 33

    Detroit, Michigan, 48202

  • Arcutis Clinical Site 20

    Fridley, Minnesota, 55432

  • Arcutis Clinical Site 14

    High Point, North Carolina, 27262

  • Arcutis Clinical Site 37

    Houston, Texas, 77004

  • Arcutis Clinical Site 13

    Houston, Texas, 77056

  • Arcutis Clinical Site 21

    Louisville, Kentucky, 40217

  • Arcutis Clinical Site 12

    Miami, Florida, 33144

  • Arcutis Clinical Site 22

    New York, New York, 10029

  • Arcutis Clinical Site 31

    Norfolk, Virginia, 23502

  • Arcutis Clinical Site 29

    Northridge, California, 91324

  • Arcutis Clinical Site 15

    Pittsburgh, Pennsylvania, 15213

  • Arcutis Clinical Site 23

    San Antonio, Texas, 78213

  • Arcutis Clinical Site 28

    San Diego, California, 92123

  • Arcutis Clinical Site 16

    Sanford, Florida, 32771

  • Arcutis Clinical Site 27

    Santa Monica, California, 90403

  • Arcutis Clinical Site 24

    Webster, Texas, 77598

Other trials in United States

Canada10 sites

  • Arcutis Clinical Site 10

    Ajax, Ontario, L1S 7K8

  • Arcutis Clinical Site 25

    London, Ontario, N6H 5L5

  • Arcutis Clinical Site 26

    Markham, Ontario, L3P 1X2

  • Arcutis Clinical Site 32

    Oakville, Ontario, L6J 7W5

  • Arcutis Clinical Site 17

    Peterborough, Ontario, K9J 5K2

  • Arcutis Clinical Site 18

    Surrey, British Columbia, V3R 6A7

  • Arcutis Clinical Site 11

    Surrey, British Columbia, V3V 0C6

  • Arcutis Clinical Site 30

    Waterloo, Ontario, N2J 1C4

  • Arcutis Clinical Site 36

    Windsor, Ontario, N8W 1E6

  • Arcutis Clinical Site 38

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

About this study

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

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.

Being tested
Roflumilast Cream 0.3%, Roflumilast Cream 0.15%, Vehicle Cream

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roflumilast Cream 0.3%Drug

    Also called ARQ-151

    Applied once daily for 12 weeks

  • Roflumilast Cream 0.15%Drug

    Also called ARQ-151

    Applied once daily for 12 weeks

  • Vehicle CreamDrug

    Applied once daily for 12 weeks

Study groups in NCT03638258
Study groupRoleWhat they receive
Roflumilast Cream 0.3%ExperimentalRoflumilast cream 0.3% topically applied QD for 12 weeks.
Receives: Drug: Roflumilast Cream 0.3%
Roflumilast Cream 0.15%ExperimentalRoflumilast cream 0.15% topically applied QD for 12 weeks.
Receives: Drug: Roflumilast Cream 0.15%
Vehicle CreamPlacebo comparatorVehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.
Receives: Drug: Vehicle Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at 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.

    Measured: Week 6

Secondary outcomes (13)

  1. Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'

    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.

    Measured: Weeks 4, 8, and 12

  2. Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score

    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.

    Measured: Baseline (Day 1) and Weeks 4, 6, 8, and 12

  3. Percent Change From Baseline in Body Surface Area (BSA) Affected

    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.

    Measured: Baseline (Day 1) and Weeks 4, 6, 8, and 12

  4. Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline

    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.

    Measured: Baseline (Day 1) and Weeks 4, 6, 8, and 12

  5. 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

    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.

    Measured: Weeks 4, 6, 8, and 12

  6. Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score

    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.

    Measured: Baseline (Day 1) and Weeks 4, 6, 8, and 12

  7. Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction

    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.

    Measured: Baseline (Day 1) and Weeks 4, 6, 8, and 12

  8. Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline

    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.

    Measured: Baseline (Day 1) and Weeks 4, 6, 8, and 12

  9. Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline

    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.

    Measured: Baseline (Day 1) and Weeks 4, 6, 8, and 12

  10. Change From Baseline in Psoriasis Symptom Diary (PSD) Total 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 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.

    Measured: Baseline (Day 1) and Weeks 4, 6, 8, and 12

  11. Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score

    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.

    Measured: Baseline (Day 1) and Weeks 4, 6, 8, and 12

  12. Change From Baseline in Dermatology Life Quality Index (DLQI) Score

    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.

    Measured: Baseline (Day 1) and Weeks 4, 6, 8, and 12

  13. Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)

    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.

    Measured: Weeks 4, 6, 8, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2018
  2. Study start21 Sep 2018
  3. Primary completion29 May 2019
  4. Study completion29 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group, double blind, vehicle-controlled study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03638258
Sponsor's protocol ID
ARQ-151-201
Acronym
ARQ-151-201
Status last verified
Aug 2022
First submitted
16 Aug 2018
Last updated
2 Sep 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Stein Gold L, Alonso-Llamazares J, Draelos ZD, Gooderham MJ, Kempers SE, Kircik LH, Lebwohl MG, Papp KA, Pariser DM, Toth DP, Yosipovitch G, Higham RC, Feng A, Berk DR. Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial. Am J Clin Dermatol. 2023 Mar;24(2):305-313. doi: 10.1007/s40257-022-00739-3. Epub 2022 Nov 12.

    PubMed 36370336

  • Lebwohl MG, Papp KA, Stein Gold L, Gooderham MJ, Kircik LH, Draelos ZD, Kempers SE, Zirwas M, Smith K, Osborne DW, Trotman ML, Navale L, Merritt C, Berk DR, Welgus H; ARQ-151 201 Study Investigators. Trial of Roflumilast Cream for Chronic Plaque Psoriasis. N Engl J Med. 2020 Jul 16;383(3):229-239. doi: 10.1056/NEJMoa2000073.

    PubMed 32668113

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Roflumilast Cream 0.3% and Roflumilast Cream 0.15% in people with Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6 (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03638258, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.

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