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Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03916081
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Arcutis, Inc.

Brief Summary:
The study will assess the safety, pharmacokinetics (PK) and efficacy of different doses of ARQ-151 cream (0.05% and 0.15%) vs placebo applied once a day for 28 days by adolescents and adults with atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: ARQ-151 cream 0.05% Drug: ARQ-151 cream 0.15% Drug: ARQ-151 cream Vehicle Phase 2

Detailed Description:
This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream 0.05% or ARQ-151 cream 0.15% or vehicle is applied QD x 4 weeks 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: ARQ-151 cream 0.05% Drug: ARQ-151 cream 0.05%
0.05% active concentration

Active Comparator: ARQ-151 cream 0.15% Drug: ARQ-151 cream 0.15%
0.15% active concentration

Placebo Comparator: ARQ-151 cream Vehicle Drug: ARQ-151 cream Vehicle
Cream placebo




Primary Outcome Measures :
  1. Eczema Area and Severity Index (EASI) Total Score Change [ Time Frame: 4 weeks ]
    Change from baseline in Eczema Area and Severity Index (EASI) Total Score at week 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.


Secondary Outcome Measures :
  1. EASI Total Score Percent Change [ Time Frame: Baseline and Week 1, Week 2, Week 4 ]
    Percent change from baseline in EASI Total Score at 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.

  2. EASI Total Score Change [ Time Frame: Baseline and Week 1 and Week 2 ]
    Change from baseline in EASI Total Score at weeks 1 and 2. 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.

  3. Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) Score [ Time Frame: Week 1, Week 2, Week 4 ]
    Proportion of patients with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score of 'clear' or 'almost clear' at each study visit. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).

  4. v-IGA-AD Score Improvement [ Time Frame: Baseline and Week 1, Week 2, Week 4 ]
    Proportion of patients with vIGA-AD score of '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 has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).

  5. Eczema Area and Severity Index (EASI75) Score Improvement [ Time Frame: Baseline and Week 1, Week 2, Week 4 ]
    Proportion of patients with a 75% or greater improvement in Eczema Area and Severity Index (EASI75) 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.

  6. EASI50 Score Improvement [ Time Frame: Baseline and Week 1, Week 2, Week 4 ]
    Proportion of patients with a 50% or greater improvement in Eczema Area and Severity Index (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.

  7. vIGA-AD Score Change [ Time Frame: Baseline and each Week 1, Week 2, Week 4 ]
    Change from baseline in vIGA-AD score at each visit. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).

  8. Body Surface Area (BSA) Involvement Change [ Time Frame: Baseline and Week 1, Week 2, Week 4 ]
    Change from baseline in BSA involvement at each study visit.

  9. Worse Itch Numerical Rating Score (WI-NRS) Pruritis Score Change [ Time Frame: Baseline and Week 1, Week 2, Week 4 ]
    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").

  10. WI-NRS Pruritus Score Improvement [ Time Frame: Baseline and Week 1, Week 2, Week 4 ]
    ≥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").



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Males and females ages 12 years and older (inclusive) at the time of consent.
  3. Clinical diagnosis of active atopic dermatitis for at least 6 months.
  4. BSA (Body Surface Area) involvement of at least 2% but no more than 25% at Baseline.
  5. vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of 'mild' ('2') or 'moderate ('3') at Baseline.
  6. EASI (Eczema Area and Severity Index) score of ≥ 5 at Baseline.
  7. 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.
  8. In good health as judged by the Investigator, based on medical history, physical examination, and clinical tests.

Exclusion Criteria:

  1. 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.
  2. Evidence of skin conditions other than AD (atopic dermatitis) that would interfere with evaluation of the effect of the study medication.
  3. Pregnant or lactating women or women planning to become pregnant during the study.
  4. Known allergies to excipients in ARQ-151 cream.
  5. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors .
  6. Subjects who are unwilling to refrain from using a tanning bed as well as outdoor tanning or excessive sun exposure.
  7. Subjects with unstable AD or who cannot discontinue systemic and/or topical therapies for the treatment of AD.
  8. 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
  9. Previous treatment with ARQ-151.
  10. Subjects with a history of chronic alcohol or drug abuse in past 6 months.
  11. 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.
  12. Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
  13. Subjects with a history of a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
  14. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916081


Contacts
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Contact: Arcutis Study Inquiry 805 418 5006 ext 5 studyinquiry@arcutis.com

Sponsors and Collaborators
Arcutis, Inc.
Investigators
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Study Director: David Berk, MD Arcutis, Inc.

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Responsible Party: Arcutis, Inc.
ClinicalTrials.gov Identifier: NCT03916081     History of Changes
Other Study ID Numbers: ARQ-151-212
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases