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Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445987
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.

Brief Summary:
Open-label, long-term safety study of ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 24 weeks. Cohort 1 subjects are rollover subjects from the ARQ-154-203 trial. Cohort 2 include treatment naive subjects. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.

Condition or disease Intervention/treatment Phase
Seborrheic Dermatitis Drug: ARQ-154 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154-203 Phase 2a randomized controlled trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Long-term safety of ARQ-154
Open-label, Long-term Safety of ARQ-154
Drug: ARQ-154
ARQ-154 foam 0.3% applied once daily for 24 weeks




Primary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: 24 Weeks ]
    Occurrence of treatment emergent adverse events

  2. Serious Adverse Events [ Time Frame: 24 Weeks ]
    Occurrence of treatment serious adverse events


Secondary Outcome Measures :
  1. Investigator Global Assessment [ Time Frame: 24 Weeks ]
    Achievement of an IGA score of 'clear' or 'almost clear' as observed at Week 12, Week 24. 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).

  2. Investigator Global Assessment [ Time Frame: 24 Weeks ]
    A 2-grade improvement in IGA from Baseline at Week 12, Week 24. 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).

  3. Investigator Global Assessment [ Time Frame: 24 Weeks ]
    Achievement of an IGA score of 'clear' or 'almost clear' plus a 2-grade improvement in IGA from baseline as observed at Week 12, Week 24. 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. Duration of Response [ Time Frame: 24 Weeks ]
    Duration of IGA Success, defined as the time from the first observation of IGA Success to the last time a subject's disease response meets the criteria for IGA Success. The duration of IGA Success for subjects who end treatment in IGA Success will be censored at the last disease assessment date.

  5. Treatment Free Interval [ Time Frame: 24 Weeks ]
    Treatment-free interval, defined among subjects who achieve a 'clear' IGA and stop treatment to all lesions, as the time from attainment of a score of 'clear' to re-starting study drug.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 (for adolescents) assent.
  2. Males and females ages 12 years and older (inclusive) at the time of consent.
  3. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.
  4. Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.

    Cohort 1 only:

  5. Subjects with seborrheic dermatitis who met eligibility criteria for ARQ-154-203, successfully completed ARQ-154-203 through Week 8 and are able to immediately enroll into this long-term safety study on the Week 8 visit of the previous study (ARQ-154-203).

    Cohort 2 subjects that have not participated on the ARQ-154-203 study:

  6. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
  7. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
  8. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day 1.
  9. Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate ('2') at Day 1.

    Cohort 2 subjects that have participated on the ARQ-154-203 study:

  10. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator.
  11. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.

Exclusion Criteria:

  1. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
  2. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
  3. Subjects unable to apply investigational product to the scalp due to physical limitation.
  4. Known allergies to excipients in ARQ-154 foam.
  5. 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 during the study period.
  6. Known or suspected:

    • severe renal insufficiency or moderate to severe hepatic disorders
    • history of severe depression, suicidal ideation or C-SSRS indicative of suicidal ideation, whether lifetime or recent/recurrent.
  7. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  8. 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.
  9. Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product.
  10. 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.
  11. 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.
  12. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members that live in the same household of enrolled subjects.

    Cohort 1 only:

  13. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in the study ARQ-154-203.
  14. Subjects that use any Excluded Medication and Treatments.

    Cohort 2 only:

  15. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Day 1 visit and during the study according to Excluded Medications and Treatments.
  16. Subjects with PHQ-8 >10 or modified PHQ-A >10 at Screening or Day 1.

    Cohort 2 subjects that have participated on the ARQ-154-203 study:

  17. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in the study ARQ-154-203.

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): NCT04445987


Contacts
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Contact: David Berk, MD 805-418-5006 ext 5 studyinquiry@arcutis.com

Locations
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Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
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Responsible Party: Arcutis Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04445987    
Other Study ID Numbers: ARQ-154-214
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous