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



Status:Enrolling by invitation
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:December 18, 2018
End Date:May 2020

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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

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.


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.
We found this trial at
20
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Fridley, Minnesota 55432
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Beverly Hills, California 90212
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Bexley, Ohio 43209
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Clinton Township, Michigan 48038
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College Station, Texas 77845
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Detroit, Michigan 48202
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Detroit, MI
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High Point, North Carolina 27262
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High Point, NC
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Houston, Texas 77004
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Houston, TX
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Louisville, Kentucky 40217
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Louisville, KY
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Miami, Florida 33144
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Miami, FL
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New York, New York 10029
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New York, NY
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Norfolk, Virginia 23502
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Northridge, California 91324
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Northridge, CA
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Pittsburgh, Pennsylvania 15213
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San Antonio, Texas 78213
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San Diego, California 92123
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San Diego, CA
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Sanford, Florida 32771
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Santa Monica, California 90403
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Santa Monica, CA
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Surrey, British Columbia
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Webster, Texas 77598
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Webster, TX
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