Atopic Dermatitis (Eczema)Phase 1NCT04156191
Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema
A Phase 1 study testing ARQ-151 cream 0.15% and ARQ-151 cream 0.05% in people with Atopic Dermatitis (Eczema), run by Arcutis Biotherapeutics, Inc. at 10 sites in United States.
Trial summary
This is a research study where all subjects will receive study medication to understand how the body processes the study medication, and to determine the PK, safety and efficacy of ARQ-151 cream 0.15% or 0.05% in adolescent and pediatric subjects with mild to moderate AD. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Atopic Dermatitis (Eczema)
- What is being tested?
- ARQ-151 cream 0.15% and ARQ-151 cream 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 10 sitesUnited States
- Study dates
- 23 Dec 2019to 2 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subject, as required by local laws.
- Males or females, 12-17 years old (inclusive; Cohort 1), or 6-11 years old (inclusive; Cohort 2), or 2-5 years old (inclusive; Cohort 3), and in the maximal usage PK study subjects aged 12 to <17 years old (Cohort 4), 6 to 11 years old (Cohort 5), 2-5 years old (Cohort 6 and Cohort 7), or 3 months to less than 2 years old (Cohort 8).
- Clinical diagnosis of active atopic dermatitis for at least 3 months (2 weeks for Cohort 8).
- EASI Score ≥5.
- vIGA-AD score of 'Mild' ('2') or 'Moderate ('3').
- Has AD involvement of 1.5 to 35% BSA (Cohorts 1-3) or ≥25% BSA (Cohorts 4-7), all excluding the scalp, palms, soles; or for Cohort 8 ≥35% BSA excluding the scalp, perioral, and below wrists/ankles .
- 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 or psychiatric condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
- Subjects with unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors.
- Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Visit 2 and during the study.
- Subjects who cannot discontinue systemic and/or topical therapies.
- 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.
Show all 19Show fewer
- Subjects with actively infected AD or any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents
- 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))
- hypersensitivity to component(s) of the investigational product
- history of severe depression, suicidal ideation, Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Subjects (12 to 17 years old, inclusive) with modified PHQ-A score ≥10 at Screening or Baseline visits.
- Subjects (6 to 11 years old, inclusive) with a CDI-2 (parent report) raw score >20 at Screening/Baseline
- Subjects with a history of a major surgery within 4 weeks prior to Baseline/Visit 1 or subjects who have a major surgery planned during the study.
- Subjects with prior exposure to ARQ-151
- Subjects 3 to <12 months old who were premature at birth
- Subject is nursing and subject's mother requires high dose systemic steroids
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Arcutis Clinical Site 07
Birmingham, Alabama, 35244
Arcutis Clinical Site 02
Coral Gables, Florida, 33146
Arcutis Clinical Site 05
Hialeah, Florida, 33016
Arcutis Clinical Site 13
Miami, Florida, 33137
Arcutis Clinical Site 01
Mt. Pleasant, South Carolina, 29464
Arcutis Clinical Site 03
Orem, Utah, 84058
Arcutis Clinical Site 11
Rancho Santa Margarita, California, 92688
Arcutis Clinical Site 06
San Antonio, Texas, 78213
Arcutis Clinical Site 12
Spokane, Washington, 99202
Arcutis Clinical Site 10
West Jordan, Utah, 84088
About this study
Official title: An Open Label, Phase 1, Pharmacokinetics, Maximal Usage Pharmacokinetics, Safety, and Efficacy Study of ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% Administered QD in Adolescent and Pediatric Subjects With Mild to Moderate Atopic Dermatitis
This is a research study where all subjects will receive study medication to understand how the body processes the study medication, and to determine the PK, safety and efficacy of ARQ-151 cream 0.15% or 0.05% in adolescent and pediatric subjects with mild to moderate AD. At entry, subjects in Cohorts 1-3 will have 1.5-35% Body Surface Area involvement (excluding the scalp, palms, soles) and mild or moderate atopic dermatitis (AD) based on vIGA-AD. Cohort 2 and Cohort 3 will be performed in parallel and may commence after results are available from ARQ-151-212, a Phase 2 study evaluating ARQ-151 cream 0.05% and 0.15% administered once a day for 4 weeks in adolescents and adults with mild to moderate AD affecting 1.5% to 35% BSA.
For the maximal usage PK study (Cohorts 4-8), subjects will have BSA involvement (excluding the scalp, palms, soles) of ≥ 35% in subjects 3 months old to 11 years old (inclusive) or ≥25% in subjects 12 to <17 years old with mild or moderate AD .
Read more
Seven groups will be evaluated, including:
- Cohort 1: ARQ-151 cream 0.15% in adolescents (12-17 years old; inclusive)
- Cohort 2: ARQ-151 cream 0.15% in children 6-11 years old (inclusive)
- Cohort 3: ARQ-151 cream 0.15% in children 2-5 years old (inclusive; will be performed in parallel with Cohort 2)
- Cohort 4: ARQ-151 cream 0.15% in adolescents 12 to <17 years old
- Cohort 5: ARQ-151 cream 0.15% in children 6-11 years old (inclusive)
- Cohort 6: ARQ-151 cream 0.15% in children 2-5 years old (inclusive)
- Cohort 7: ARQ-151 cream 0.05% in children 2-5 years old (inclusive)
- Cohort 8: ARQ-151 cream 0.05% in children 3 months old to less than 2 years old
Subjects will apply ARQ-151 cream 0.15% or 0.05% once a day for 28 days to all AD affected areas and any newly appearing AD lesions that arise during the study, except on the scalp.
- Conditions
- Atopic Dermatitis (Eczema)
- Being tested
- ARQ-151 cream 0.15%, ARQ-151 cream 0.05%
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ-151 cream 0.15%Drug
ARQ-151 cream 0.15% applied to atopic dermatitis lesions once a day for 28 days
ARQ-151 cream 0.05%Drug
ARQ-151 cream 0.05% applied to atopic dermatitis lesions once a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| ARQ-151 cream 0.15% or 0.05% | Experimental | Open-label study of 0.15% or 0.05% active concentration Receives: Drug: ARQ-151 cream 0.15%; Drug: ARQ-151 cream 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of roflumilast and its N-oxide metabolite
Maximum observed plasma concentration of drug in plasma
Measured: 4 weeks
Area under the plasma concentration-time curve within a dosing interval (AUC) for roflumilast and its N-oxide metabolite
The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in plasma.
Measured: 4 weeks
Treatment Emergent Adverse Events (TEAE)
Number of participants with adverse events during treatment will be assessed.
Measured: 4 weeks
Secondary outcomes (7)
Eczema Area and Severity Index (EASI) Total Score Change and Percent Change in Total Score
Change in EASI Total Score at weeks 2 and 4 and percent change from baseline in EASI Total Score at weeks 2 and 4. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
Measured: Baseline, Week 2, and Week 4
Eczema Area and Severity Index Score 100%, 90%, 75%, and 50% Improvement (EASI100, EASI90, EASI75, and EASI50)
Proportion of patients with a 100%, 90%, 75%, and 50% or greater improvement in Eczema Area and Severity Index (EASI100, EASI90, EASI75, and EASI50) score from baseline to each study visit. EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
Measured: Baseline, Week 2, and Week 4
Achievement of a Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score of 'clear' or 'almost clear' at each study visit, or 'clear' or 'almost clear' with a 2-point improvement from baseline at each study visit
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
Measured: Baseline, Week 2, Week 4
Change from baseline in vIGA-AD score at each study visit
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
Measured: Baseline, Week 2, Week 4
Body Surface Area (BSA) Involvement Change
Change from baseline in BSA involvement at each study visit.
Measured: Baseline, Week 2, Week 4
Worse Itch Numerical Rating Score (WI-NRS) Pruritis Score Change
Change from baseline in WI-NRS pruritus score at each study visit. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Measured: Baseline, Week 2, Week 4
WI-NRS Pruritus Score Improvement
≥4-point improvement from Baseline in WI-NRS pruritus score at each study visit. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Measured: Baseline, Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start23 Dec 2019
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (Eczema)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 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
- NCT04156191
- Sponsor's protocol ID
- ARQ-151-105
- Status last verified
- Jul 2023
- First submitted
- 3 Nov 2019
- Last updated
- 24 Jul 2023
- Results posted
- No
- 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 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 1, Pharmacokinetics, Maximal Usage Pharmacokinetics, Safety, and Efficacy Study of ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% Administered QD in Adolescent and Pediatric Subjects With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04156191
- Acronym / sponsor ID
- ARQ-151-105
- Conditions
- Atopic Dermatitis (Eczema)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study where all subjects will receive study medication to understand how the body processes the study medication, and to determine the PK, safety and efficacy of ARQ-151 cream 0.15% or 0.05% in adolescent and pediatric subjects with mild to moderate AD. At entry, subjects in Cohorts 1-3 will have 1.5-35% Body Surface Area involvement (excluding the scalp, palms, soles) and mild or moderate atopic dermatitis (AD) based on vIGA-AD. Cohort 2 and Cohort 3 will be performed in parallel and may commence after results are available from ARQ-151-212, a Phase 2 study evaluating ARQ-151 cream 0.05% and 0.15% administered once a day for 4 weeks in adolescents and adults with mild to moderate AD affecting 1.5% to 35% BSA.
For the maximal usage PK study (Cohorts 4-8), subjects will have BSA involvement (excluding the scalp, palms, soles) of ≥ 35% in subjects 3 months old to 11 years old (inclusive) or ≥25% in subjects 12 to <17 years old with mild or moderate AD .
Seven groups will be evaluated, including:
- Cohort 1: ARQ-151 cream 0.15% in adolescents (12-17 years old; inclusive)
- Cohort 2: ARQ-151 cream 0.15% in children 6-11 years old (inclusive)
- Cohort 3: ARQ-151 cream 0.15% in children 2-5 years old (inclusive; will be performed in parallel with Cohort 2)
- Cohort 4: ARQ-151 cream 0.15% in adolescents 12 to <17 years old
- Cohort 5: ARQ-151 cream 0.15% in children 6-11 years old (inclusive)
- Cohort 6: ARQ-151 cream 0.15% in children 2-5 years old (inclusive)
- Cohort 7: ARQ-151 cream 0.05% in children 2-5 years old (inclusive)
- Cohort 8: ARQ-151 cream 0.05% in children 3 months old to less than 2 years old
Subjects will apply ARQ-151 cream 0.15% or 0.05% once a day for 28 days to all AD affected areas and any newly appearing AD lesions that arise during the study, except on the scalp.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARQ-151 cream 0.15% or 0.05% | Experimental | Drug: ARQ-151 cream 0.15%, Drug: ARQ-151 cream 0.05%Open-label study of 0.15% or 0.05% active concentration |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subject, as required by local laws.
- Males or females, 12-17 years old (inclusive; Cohort 1), or 6-11 years old (inclusive; Cohort 2), or 2-5 years old (inclusive; Cohort 3), and in the maximal usage PK study subjects aged 12 to <17 years old (Cohort 4), 6 to 11 years old (Cohort 5), 2-5 years old (Cohort 6 and Cohort 7), or 3 months to less than 2 years old (Cohort 8).
- Clinical diagnosis of active atopic dermatitis for at least 3 months (2 weeks for Cohort 8).
- EASI Score ≥5.
- vIGA-AD score of 'Mild' ('2') or 'Moderate ('3').
Key exclusion criteria (19 listed)
- Subjects with any serious medical or psychiatric condition or clinically significant physical examination or test abnormality that would prevent study participation or place the subject at significant risk.
- Subjects with unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors.
- Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Visit 2 and during the study.
- Subjects who cannot discontinue systemic and/or topical therapies.
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 |
|---|---|---|
| ARQ-151 cream 0.15%ARQ-151 cream 0.15% applied to atopic dermatitis lesions once a day for 28 days | Drug | ARQ-151 cream 0.15% or 0.05% |
| ARQ-151 cream 0.05%ARQ-151 cream 0.05% applied to atopic dermatitis lesions once a day for 28 days | Drug | ARQ-151 cream 0.15% or 0.05% |
Primary outcome
Maximum Plasma Concentration (Cmax) of roflumilast and its N-oxide metabolite
Time frame: 4 weeks
Maximum observed plasma concentration of drug in plasma
Area under the plasma concentration-time curve within a dosing interval (AUC) for roflumilast and its N-oxide metabolite
Time frame: 4 weeks
The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in plasma.
Treatment Emergent Adverse Events (TEAE)
Time frame: 4 weeks
Number of participants with adverse events during treatment will be assessed.
7 secondary outcomes
Eczema Area and Severity Index (EASI) Total Score Change and Percent Change in Total Score
Time frame: Baseline, Week 2, and Week 4
Eczema Area and Severity Index Score 100%, 90%, 75%, and 50% Improvement (EASI100, EASI90, EASI75, and EASI50)
Time frame: Baseline, Week 2, and Week 4
Achievement of a Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score of 'clear' or 'almost clear' at each study visit, or 'clear' or 'almost clear' with a 2-point improvement from baseline at each study visit
Time frame: Baseline, Week 2, Week 4
Change from baseline in vIGA-AD score at each study visit
Time frame: Baseline, Week 2, Week 4
Body Surface Area (BSA) Involvement Change
Time frame: Baseline, Week 2, Week 4
Worse Itch Numerical Rating Score (WI-NRS) Pruritis Score Change
Time frame: Baseline, Week 2, Week 4
WI-NRS Pruritus Score Improvement
Time frame: Baseline, Week 2, Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
Related trials for Atopic Dermatitis (Eczema)
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARQ-151 cream 0.15% and ARQ-151 cream 0.05% in people with Atopic Dermatitis (Eczema), run by Arcutis Biotherapeutics, Inc. at 10 sites in United States.
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 19 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Plasma Concentration (Cmax) of roflumilast and its N-oxide metabolite (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 24 Jul 2023.