Atopic DermatitisPhase 2NCT03916081
Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis
A Phase 2 study testing Roflumilast Cream 0.05% and Roflumilast Cream 0.15% in people with Atopic Dermatitis, run by Arcutis Biotherapeutics, Inc. at 20 sites in 2 countries.
Trial summary
The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Roflumilast Cream 0.05% and Roflumilast Cream 0.15%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 31 May 2019to 4 Nov 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants legally competent to sign and give informed consent or, in the case of adolescents, 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.
- Clinical diagnosis of active atopic dermatitis for at least 6 months.
- BSA (Body Surface Area) involvement of at least 2% but no more than 25% at Baseline.
- vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild' ('2') or 'moderate ('3') at Baseline.
- EASI (Eczema Area and Severity Index) score of ≥ 5 at Baseline.
- Females of childbearing potential must have a negative serum pregnancy test at Screening and, if sexually active, agree to use birth control throughout the trial.
- In good health as judged by the Investigator, based on medical history, physical examination, and clinical tests.
Who cannot join
- Subjects with any serious medical condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
- Evidence of skin conditions other than AD (atopic dermatitis) 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.
- Known allergies to excipients in ARQ-151 cream.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors .
- Subjects who are unwilling to refrain from using a tanning bed as well as outdoor tanning or excessive sun exposure.
Show all 17Show fewer
- Subjects with unstable AD or who cannot discontinue systemic and/or topical therapies for the treatment of AD.
- Known or suspected:
- severe renal insufficiency or moderate to severe hepatic disorders (Child-Pugh B or C)
- history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
- within last 5 years, a history of severe depression, suicidal ideation
- Previous treatment with ARQ-151.
- Subjects with a history of chronic alcohol or drug abuse in past 6 months.
- 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.
- Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
- Subjects with a history of a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
- Subjects with any condition which makes them unsuitable for clinical study participation or are family members of the clinical study site, clinical study staff, sponsor, or family members of enrolled subjects.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States17 sites
Arcutis Clinical Site 08
Bexley, Ohio, 43209
Arcutis Clinical Site 16
Boise, Idaho, 83713
Arcutis Clinical Site 09
College Station, Texas, 77845
Arcutis Clinical Site 03
Fridley, Minnesota, 55432
Arcutis Clinical Site 19
Hialeah, Florida, 33016
Arcutis Clinical Site 02
High Point, North Carolina, 27262
Arcutis Clinical Site 12
Indianapolis, Indiana, 46250
Arcutis Clinical Site 15
Metairie, Louisiana, 70006
Arcutis Clinical Site 18
Miami, Florida, 33174
Arcutis Clinical Site 20
Murfreesboro, Tennessee, 37130
Arcutis Clinical Site 23
Pittsburgh, Pennsylvania, 15213
Arcutis Clinical Site 13
Plainfield, Indiana, 46168
Arcutis Clinical Site 21
Richmond, Virginia, 23224
Arcutis Clinical Site 04
San Antonio, Texas, 78213
Arcutis Clinical Site 01
San Diego, California, 92123
Arcutis Clinical Site 17
Sanford, Florida, 32771
Arcutis Clinical Site 25
Scottsdale, Arizona, 85254
Canada3 sites
Arcutis Clinical Site 14
Cobourg, Ontario, K9A 4J9
Arcutis Clinical Site 06
Montreal, Quebec, H2K 4L5
Arcutis Clinical Site 10
Richmond Hill, Ontario, L4B 1A5
About this study
Official title: A Phase 2, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% and ARQ-151 Cream 0.15% Administered QD (Quaque Die) in Adolescent and Adult Subjects With Atopic Dermatitis
The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.
Read the detailed description
This is a parallel group, double blind, vehicle-controlled study in which roflumilast cream 0.05% or 0.15% or vehicle is applied QD x 28 days to adolescent and adult subjects with atopic dermatitis. A subset of subjects will have serial PK testing, which will include the first few adolescents and adults enrolled in the study.
- Conditions
- Atopic Dermatitis
- Being tested
- Roflumilast Cream 0.05%, Roflumilast Cream 0.15%, Vehicle Cream
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast Cream 0.05%Drug
Also called ARQ-151
Roflumilast 0.05% cream for topical application
Roflumilast Cream 0.15%Drug
Also called ARQ-151
Roflumilast 0.15% cream for topical application
Vehicle CreamDrug
Inactive vehicle cream matched to roflumilast cream for topical application.
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast Cream 0.05% | Active comparator | Participants apply roflumilast cream 0.05% QD for 28 days. Receives: Drug: Roflumilast Cream 0.05% |
| Roflumilast Cream 0.15% | Active comparator | Participants apply roflumilast cream 0.15% QD for 28 days. Receives: Drug: Roflumilast Cream 0.15% |
| Vehicle Cream | Placebo comparator | Participants apply vehicle cream QD for 28 days. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
The least squares (LS) mean (SD) change from baseline in EASI Total Score at Week 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Measured: Baseline and Week 4
Secondary outcomes (9)
Percentage Change From Baseline in EASI Total Score
The LS mean (SD) percentage change from baseline in EASI Total Score at Weeks 1, 2, and 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Measured: Baseline and Weeks 1, 2, and 4
Mean Change From Baseline in EASI Total Score at Weeks 1 and 2
The LS mean (SD) change from baseline in EASI Total Score at Weeks 1 and 2 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Measured: Baseline and Weeks 1 and 2
Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50)
The number of participants with a decrease of at least 50% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Measured: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)
The number of participants with a decrease of at least 75% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Measured: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90)
The number of participants with a decrease of at least 90% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases.
Measured: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving a 100% Decrease From Baseline in EASI Score (EASI-100)
The number of participants with a decrease of 100% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. In some instances, it was not possible to compare roflumilast to vehicle due to low number of cases.
Measured: Baseline and Weeks 1, 2, and 4
Mean Change From Baseline in Body Surface Area (BSA) Involvement
The LS mean (SE) change from baseline in BSA involvement at Weeks 1, 2, and 4 is presented. The BSA affected by AD was determined by the subject's hand method, where the subject's hand (including fingers) surface area was assumed to equal 1% of BSA. Negative scores indicate improvement of symptoms, whereas positive scores indicate worsening.
Measured: Baseline and Weeks 1, 2, and 4
Worse Itch Numerical Rating Score (WI-NRS) Score Change
The LS mean (SE) change from baseline in WI-NRS score is presented. 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. Higher scores indicate greater symptom severity.
Measured: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score
The number of participants achieving a ≥4-point improvement from Baseline in WI-NRS score is presented. 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. Higher scores indicate greater symptom severity.
Measured: Baseline and Weeks 1, 2, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start31 May 2019
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
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 Atopic DermatitisStudies 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
- 136 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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916081
- Sponsor's protocol ID
- ARQ-151-212
- Status last verified
- Aug 2022
- First submitted
- 10 Apr 2019
- Last updated
- 13 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% and ARQ-151 Cream 0.15% Administered QD (Quaque Die) in Adolescent and Adult Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03916081
- Acronym / sponsor ID
- ARQ-151-212
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Posted 13 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.
Detailed description
This is a parallel group, double blind, vehicle-controlled study in which roflumilast cream 0.05% or 0.15% or vehicle is applied QD x 28 days to adolescent and adult subjects with atopic dermatitis. A subset of subjects will have serial PK testing, which will include the first few adolescents and adults enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Roflumilast Cream 0.05% | Active comparator | Drug: Roflumilast Cream 0.05%Participants apply roflumilast cream 0.05% QD for 28 days. |
| Roflumilast Cream 0.15% | Active comparator | Drug: Roflumilast Cream 0.15%Participants apply roflumilast cream 0.15% QD for 28 days. |
| Vehicle Cream | Placebo comparator | Drug: Vehicle CreamParticipants apply vehicle cream QD for 28 days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Participants legally competent to sign and give informed consent or, in the case of adolescents, 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.
- Clinical diagnosis of active atopic dermatitis for at least 6 months.
- BSA (Body Surface Area) involvement of at least 2% but no more than 25% at Baseline.
- vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild' ('2') or 'moderate ('3') at Baseline.
Key exclusion criteria (17 listed)
- Subjects with any serious medical condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
- Evidence of skin conditions other than AD (atopic dermatitis) 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.
- Known allergies to excipients in ARQ-151 cream.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors .
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 Cream 0.05%Also: ARQ-151Roflumilast 0.05% cream for topical application | Drug | Roflumilast Cream 0.05% |
| Roflumilast Cream 0.15%Also: ARQ-151Roflumilast 0.15% cream for topical application | Drug | Roflumilast Cream 0.15% |
| Vehicle CreamInactive vehicle cream matched to roflumilast cream for topical application. | Drug | Vehicle Cream |
Primary outcome
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
Time frame: Baseline and Week 4
The least squares (LS) mean (SD) change from baseline in EASI Total Score at Week 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
9 secondary outcomes
Percentage Change From Baseline in EASI Total Score
Time frame: Baseline and Weeks 1, 2, and 4
Mean Change From Baseline in EASI Total Score at Weeks 1 and 2
Time frame: Baseline and Weeks 1 and 2
Number of Participants Achieving a 50% Decrease From Baseline in EASI Score (EASI-50)
Time frame: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)
Time frame: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving a 90% Decrease From Baseline in EASI Score (EASI-90)
Time frame: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving a 100% Decrease From Baseline in EASI Score (EASI-100)
Time frame: Baseline and Weeks 1, 2, and 4
Mean Change From Baseline in Body Surface Area (BSA) Involvement
Time frame: Baseline and Weeks 1, 2, and 4
Worse Itch Numerical Rating Score (WI-NRS) Score Change
Time frame: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score
Time frame: Baseline and Weeks 1, 2, and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, Inc.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast Cream 0.05% and Roflumilast Cream 0.15% in people with Atopic Dermatitis, run by Arcutis Biotherapeutics, Inc. at 20 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 8 inclusion and 17 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 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 13 Feb 2023). 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?
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 (time frame: Baseline and Week 4). 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 13 Feb 2023.