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Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03764475
Recruitment Status : Not yet recruiting
First Posted : December 5, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Arcutis, Inc.

Brief Summary:
Open-label, long-term safety study of ARQ-151 cream 0.3% in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: ARQ-151 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Note: Subjects that consent to enter this open-label safety study have previously completed a companion study (ARQ-151-201 Phase 2 randomized controlled trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Adult Subjects With Chronic Plaque Psoriasis Who Have Completed Preceding Study ARQ-151-201 Phase 2 Randomized Controlled Trial
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Long-term Safety of ARQ-151
Open Label Long-term Safety of ARQ-151
Drug: ARQ-151
ARQ-151 cream 0.3% applied once daily for 52 weeks




Primary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: Scheduled and unscheduled visits over 52 weeks of the study ]
    Occurrence of treatment emergent adverse events

  2. Serious Adverse Events [ Time Frame: Scheduled and unscheduled visits over 52 weeks of the study ]
    Occurrence of Serious Adverse Events


Secondary Outcome Measures :
  1. IGA [ Time Frame: Scheduled and unscheduled visits over 52 weeks of the study ]
    Proportion (%) of subjects achieving an Investigator Global Assessment (IGA) of 'clear' or 'almost clear', as observed at efficacy baseline and subsequent scheduled visits (IGA global assessment scale is an ordinal scale with five severity grades where 'clear' or 'almost clear' have scores of 0 and 1, respectively).

  2. Duration of Response [ Time Frame: Scheduled and unscheduled visits over 52 weeks of the study ]
    In subjects who achieve a 'clear' IGA score (see outcome 3) and stop treatment to all lesions, time to re-starting study drug



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Ages Eligible for Study:   18 Years and older   (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
  2. Males and females ages 18 years and older
  3. Subjects with chronic plaque psoriasis who met eligibility criteria for ARQ-151-201, successfully completed ARQ-151-201 through Week 12, and are able to enroll into this long-term safety study on the Week 12 visit of the previous study (ARQ-151-201).
  4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial. Highly effective forms of contraception include: oral/implant/injectable/transdermal contraceptives, intrauterine device, or partner's vasectomy. If barrier methods are used (e.g., condom with spermicide, diaphragm with spermicide), then 2 forms of conception are required. The use of abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice and a backup method has been identified if the subject becomes sexually active.
  5. Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).

Exclusion Criteria:

  1. Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in Study ARQ-151-201.
  2. Subjects that use any Excluded Medications and Treatments
  3. Current diagnosis of guttate, erythrodermic/exfoliative, palmoplantar, or pustular psoriasis.
  4. 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.
  5. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin during the study period.
  6. Known or suspected:

    • severe renal insufficiency or severe hepatic disorders
    • hypersensitivity to component(s) of the investigational products
    • history of severe depression, suicidal ideation
  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 drug abuse within 6 months of initiation of study medication.
  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.

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): NCT03764475


Contacts
Contact: Howard Welgus, MD 650-847-4115 ext 5 studyinquiry@arcutis.com

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Sponsors and Collaborators
Arcutis, Inc.

Responsible Party: Arcutis, Inc.
ClinicalTrials.gov Identifier: NCT03764475     History of Changes
Other Study ID Numbers: ARQ-151-202
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases