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

Use our guide to learn which trials are right for you!

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
sites
Sanford, Florida 32771
?
mi
from
Sanford, FL
Click here to add this to my saved trials
Beverly Hills, California 90212
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Bexley, Ohio 43209
?
mi
from
Bexley, OH
Click here to add this to my saved trials
Clinton Township, Michigan 48038
?
mi
from
Clinton Township, MI
Click here to add this to my saved trials
College Station, Texas 77845
?
mi
from
College Station, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Fridley, Minnesota 55432
?
mi
from
Fridley, MN
Click here to add this to my saved trials
High Point, North Carolina 27262
?
mi
from
High Point, NC
Click here to add this to my saved trials
Houston, Texas 77004
?
mi
from
Houston, TX
Click here to add this to my saved trials
Louisville, Kentucky 40217
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Miami, Florida 33144
?
mi
from
Miami, FL
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Northridge, California 91324
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
San Antonio, Texas 78213
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Monica, California 90403
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Surrey, British Columbia
?
mi
from
Surrey,
Click here to add this to my saved trials
Webster, Texas 77598
?
mi
from
Webster, TX
Click here to add this to my saved trials