A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis

Last updated: February 18, 2020
Sponsor: Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Rash

Scalp Disorders

Warts

Treatment

N/A

Clinical Study ID

NCT03759197
188-0551-305
  • Ages > 18
  • All Genders

Study Summary

This Phase 3 study (Study 305) has been designed to determine and compare the efficacy and safety of 188-0551 Spray and Vehicle Spray applied twice daily for up to four weeks in subjects with plaque psoriasis. Subjects will be instructed to apply the test article (188-0551 Spray or Vehicle Spray) 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Subject has provided written informed consent.

  3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2%and no more than 10% body surface area (BSA) (excluding the face, scalp, groin,axillae, and other intertriginous areas).

  4. Subject has moderate to severe plaque psoriasis.

  5. Subject is willing and able to apply the test article as directed, comply with studyinstructions, and commit to all follow-up visits for the duration of the study.

  6. Females must be post-menopausal , surgically sterile , or use an effective method ofbirth control. , Women of childbearing potential (WOCBP) must have a negative urinepregnancy test (UPT) at the Baseline Visit.

Exclusion

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 palmar/plantar psoriasis.

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

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

  6. Subject has been previously enrolled in this study and treated with a test article. Other protocol defined inclusion or exclusion criteria assessed by the study staff mayapply.

Study Design

Total Participants: 206
Study Start date:
November 26, 2018
Estimated Completion Date:
August 27, 2019

Connect with a study center

  • Site 06

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Site 09

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Site 07

    Fremont, California 94538
    United States

    Site Not Available

  • Site 02

    Aventura, Florida 33180
    United States

    Site Not Available

  • Site 04

    Brandon, Florida 33544
    United States

    Site Not Available

  • Site 01

    Largo, Florida 33770
    United States

    Site Not Available

  • Site 05

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Site 08

    Albany, Indiana 47150
    United States

    Site Not Available

  • Site 03

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Site 11

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Site 12

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Site 10

    Fountain Inn, South Carolina 92708
    United States

    Site Not Available

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