A Comparison of 188-0551 Solution Versus Vehicle Solution in Subjects With Plaque Psoriasis (Study 203)



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:8/12/2018
Start Date:January 26, 2017
End Date:December 6, 2017

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A Double-Blind, Randomized, Multicenter, Vehicle-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 188-0551 in Subjects With Plaque Psoriasis Receiving Up To Four Weeks of Twice-Daily Treatment

This Phase 2 study (Study 203) has been designed to determine and compare the efficacy and
safety of 188-0551 Solution and Vehicle Solution applied twice daily for up to four weeks in
subjects with plaque psoriasis. Subjects will be instructed to apply the test article
(188-0551 Solution or Vehicle Solution) to all psoriasis plaques within the designated
Treatment Area twice daily for four weeks (Study Day 29), unless the investigator verifies
the subject's psoriasis has cleared at Day 15, then test article application will be for 2
weeks (Study Day 15).


Inclusion Criteria:

1. Subject is male or non-pregnant female and is at least 18 years of age.

2. Subject has provided written informed consent.

3. Subject is willing and able to apply the test article(s) as directed.

4. Subject has a clinical diagnosis of stable plaque psoriasis.

5. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 =
moderate) at the Baseline Visit.

6. Females must be post-menopausal, surgically sterile or use an effective method of
birth control, with a negative urine pregnancy test (UPT) at the Baseline Visit.

Exclusion Criteria:

1. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

2. Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

3. Subject has a physical condition which, in the investigator's opinion, might impair
evaluation of plaque psoriasis.

4. Subject has used any phototherapy (including laser), photo-chemotherapy or other forms
of photo based therapy for the treatment of their psoriasis within 30 days prior to
the Baseline Visit.

5. Subject has used any systemic tofacitinib, apremilast, methotrexate, retinoids,
systemic corticosteroids [including intralesional, intra-articular, and intramuscular
corticosteroids], cyclosporine or analogous products within 90 days prior to the
Baseline Visit.

6. Subject has used any systemic anti-inflammatory biologic therapy.

7. Subject had prolonged exposure to natural or artificial sources of ultraviolet
radiation within 30 days prior to the Baseline Visit or is intending to have such
exposure during the study which in the opinion of the investigator is thought to
modify the subject's disease.

8. Subject has used topical body (excluding the scalp) psoriasis therapy (including coal
tar, anthralin, steroids, retinoids and vitamin D analogs) within 14 days prior to the
Baseline Visit.

9. Subject has used emollients/moisturizers on areas to be treated within four hours
prior to clinical evaluation at the Baseline Visit.

10. Subject is currently using lithium or Plaquenil (hydroxychloroquine).

11. Subject is currently using a beta-blocking medication (e.g., propranolol) or
angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized,
in the opinion of the investigator.

12. Subject has a history of sensitivity to corticosteroids or any of the ingredients in
the test articles.

13. Subject is pregnant, lactating, or is planning to become pregnant during the study.

14. Subject is currently enrolled in an investigational drug or device study.

15. Subject has used an investigational drug or investigational device treatment within 30
days prior to the Baseline Visit.

16. Subject has been previously enrolled in this study and treated with a test article.
We found this trial at
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Arlington Heights, Illinois 60004
Phone: 847-392-5440
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