Plaque PsoriasisPhase 2NCT04128007
Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis
A Phase 2 study testing Roflumilast foam 0.3% in people with Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 47 sites in 4 countries.
Trial summary
This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Roflumilast foam 0.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 47 sitesin 4 countries
- Study dates
- 13 Jan 2020to 25 Sep 2020
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants legally competent to read, write, sign and give informed consent, or, in the case of adolscents, assent with consent of a parent(s) or legal guardian, as required by local laws.
- Males and females ages 12 years and older (inclusive) at the time of consent for assent (for adolescents).
- Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity (S-IGA) of at least Mild ('2') at Baseline.
- A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline.
- A PASI score of at least 2 (excluding the palms and soles) at Baseline.
- Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
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- Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
- Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
- Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
- Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
Who cannot join
- Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- Subjects currently taking lithium or antimalarial drugs.
- Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors).
- Current diagnosis of non-plaque forms of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis.
- Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
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- Known allergies to excipients in ARQ-154.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
- Subjects with PHQ-8 >/= 10 or modified PHQ-A >/= 10 at Screening or Baseline.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- 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 the investigational product.
- Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
- 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.
- Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
- Subjects with active infection that required oral or intravenous administration of antibiotics, antifungal, or antiviral agents within 7 days of Baseline/Day 0.
- Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members residing in the same household of enrolled subjects.
Trial locations and contacts
47 sites in 4 countries.
47 sites in 4 countries
United States31 sites
Arcutis Biotherapeutics Site 70
Arlington, Texas, 76011
Arcutis Biotherapeutics Clinical Site 76
Austin, Texas, 78759
Arcutis Biotherapeutics Clinical Site 96
Bexley, Ohio, 43209
Arcutis Biotherapeutics Clinical Site 91
Boynton Beach, Florida, 33437
Arcutis Biotherapeutics Clinical Site 80
Broomall, Pennsylvania, 19008
Arcutis Biotherapeutics Clinical Site 86
College Station, Texas, 77845
Arcutis Biotherapeutics Clinical Site 20
Coral Gables, Florida, 33134
Arcutis Biotherapeutics Clinical Site 79
Covington, Louisiana, 70433
Arcutis Biotherapeutics Clinical Site 21
Cromwell, Connecticut, 06416
Arcutis Biotherapeutics Clinical Site 72
Fremont, California, 94538
Arcutis Biotherapeutics Clinical Site 73
Fridley, Minnesota, 55432
Arcutis Biotherapeutics Clinical Site 87
High Point, North Carolina, 27262
Arcutis Biotherapeutics Clinical Site 74
Houston, Texas, 77056
Arcutis Biotherapeutics Clinical Site 78
Indianapolis, Indiana, 46250
Arcutis Biotherapeutics Clinical Site 77
Louisville, Kentucky, 40217
Arcutis Biotherapeutics Clinical Site 94
Metairie, Louisiana, 70006
Arcutis Biotherapeutics Clinical Site 88
Miami, Florida, 33144
Arcutis Biotherapeutics Clinical Site 90
Miami, Florida, 33714
Arcutis Biotherapeutics Clinical Site 97
Murfreesboro, Tennessee, 37130
Arcutis Biotherapeutics Clinical Site 81
Norfolk, Virginia, 23502
Arcutis Biotherapeutics Clinical Site 89
Pflugerville, Texas, 78660
Arcutis Biotherapeutics Clinical Site 95
Plainfield, Indiana, 46168
Arcutis Biotherapeutics Clinical Site 82
Portland, Oregon, 97210
Arcutis Biotherapeutics Clinical Site 98
Portsmouth, New Hampshire, 03801
Arcutis Biotherapeutics Clinical Site 75
Richmond, Virginia, 23220
Arcutis Biotherapeutics Clinical Site 71
Rogers, Arkansas, 72758
Arcutis Biotherapeutics Clinical Site 99
Rolling Meadows, Illinois, 60008
Arcutis Biotherapeutics Clinical Site 84
Saint Joseph, Missouri, 64506
Arcutis Biotherapeutics Clinical Site 93
San Antonio, Texas, 78213
Arcutis Biotherapeutics Clinical Site 85
San Diego, California, 92123
Arcutis Biotherapeutics Clinical Site 83
Sweetwater, Florida, 33172
Canada7 sites
Arcutis Biotherapeutics Clinical Site 61
Barrie, Ontario, L4M 7G1
Arcutis Biotherapeutics Clinical Site 64
Calgary, Alberta, T1Y0B4
Arcutis Biotherapeutics Clinical Site 60
London, Ontario, N6H5L5
Arcutis Biotherapeutics Clinical Site 66
Montreal, Quebec, H2X 2V1
Arcutis Biotherapeutics Clinical Site 62
Peterborough, Ontario, K9J 5K2
Arcutis Biotherapeutics Clinical Site 63
Waterloo, Ontario, N2J 1C4
Arcutis Biotherapeutics Clinical Site 65
Westmount, Quebec, H3Z 2S6
Bulgaria5 sites
Arcutis Biotherapeutics Clinical Site 11
Pleven, 5800
Arcutis Biotherapeutics Clinical Site 13
Sevlievo, 5402
Arcutis Biotherapeutics Clinical Site 14
Sofia, 1592
Arcutis Biotherapeutics Clinical Site 10
Sofia, 1606
Arcutis Biotherapeutics Clinical Site 12
Stara Zagora, 6003
Australia4 sites
Arcutis Biotherapeutics Clinical Site 50
East Melbourne, Victoria, 3002
Arcutis Biotherapeutics Clinical Site 54
Hectorville, South Australia, 5073
Arcutis Biotherapeutics Clinical Site 51
Kogarah, New South Wales, 2217
Arcutis Biotherapeutics Clinical Site 52
Westmead, New South Wales, 2145
About this study
Official title: A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults With Scalp and Body Psoriasis
This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis
Read the detailed description
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body psoriasis
- Conditions
- Plaque Psoriasis
- Being tested
- Roflumilast foam 0.3%, Vehicle foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast foam 0.3%Drug
Also called ARQ-154
experimental
Vehicle foamDrug
Also called placebo
experimental
| Study group | Role | What they receive |
|---|---|---|
| ARQ-154 foam 0.3% | Experimental | active Receives: Drug: Roflumilast foam 0.3% |
| ARQ foam VehicleRQ-154 foam Vehicle | Placebo comparator | placebo Receives: Drug: Vehicle foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale
The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
Measured: Week 8
Secondary outcomes (6)
Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8
The number of participants achieving success in the B-IGA scale is presented for each arm. Success is defined as a B-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline. The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
Measured: Week 8
Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score
The number of participants with a baseline SI-NRS score ≥4 who achieve success (a ≥4-point improvement from Baseline) at Weeks 2, 4, and 8 is presented for each arm. The SI-NRS is a participant-reported rating of severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ('no itch') to 10 ('worst imaginable itch'), with higher scores indicating greater symptom severity. Results are based on observed data only.
Measured: Baseline and Weeks 2, 4, 8
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
The change from baseline in total PSD scores at Weeks 4 and 8 is presented for each arm. 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.
Measured: Baseline and Weeks 4 and 8
Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score
The time to achieve PSSI-50 (i.e., a 50% reduction from baseline in PSSI score) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating greater symptom severity. Results are based on observed data only.
Measured: Up to 8 weeks
Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75)
The number of participants achieving a 75% reduction in PSSI score (i.e., PSSI-75) from baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only.
Measured: Week 8
Number of Participants Achieving PSSI-90
The number of participants achieving a 90% reduction from baseline PSSI score (i.e., PSSI-90) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start13 Jan 2020
- Primary completion23 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Berk, MD, Study director, Arcutis Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128007
- Sponsor's protocol ID
- ARQ-154-204
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2019
- Last updated
- 26 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults With Scalp and Body Psoriasis
- ClinicalTrials.gov ID
- NCT04128007
- Acronym / sponsor ID
- ARQ-154-204
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 30 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis
Detailed description
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARQ-154 foam 0.3% | Experimental | Drug: Roflumilast foam 0.3%active |
| ARQ foam VehicleRQ-154 foam Vehicle | Placebo comparator | Drug: Vehicle foamplacebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Participants legally competent to read, write, sign and give informed consent, or, in the case of adolscents, assent with consent of a parent(s) or legal guardian, as required by local laws.
- Males and females ages 12 years and older (inclusive) at the time of consent for assent (for adolescents).
- Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity (S-IGA) of at least Mild ('2') at Baseline.
- A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline.
- A PASI score of at least 2 (excluding the palms and soles) at Baseline.
Key exclusion criteria (18 listed)
- Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- Subjects currently taking lithium or antimalarial drugs.
- Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors).
- Current diagnosis of non-plaque forms of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast foam 0.3%Also: ARQ-154experimental | Drug | ARQ-154 foam 0.3% |
| Vehicle foamAlso: placeboexperimental | Drug | ARQ foam VehicleRQ-154 foam Vehicle |
Primary outcome
Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale
Time frame: Week 8
The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
6 secondary outcomes
Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8
Time frame: Week 8
Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score
Time frame: Baseline and Weeks 2, 4, 8
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
Time frame: Baseline and Weeks 4 and 8
Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score
Time frame: Up to 8 weeks
Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75)
Time frame: Week 8
Number of Participants Achieving PSSI-90
Time frame: Baseline and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
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A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Berk, MD study director
Arcutis Biotherapeutics
47 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast foam 0.3% in people with Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 47 sites in 4 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 10 inclusion and 18 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Canada, Bulgaria, Australia. 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 30 Sep 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?
Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2022.