NCT03759197

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

November 28, 2018

Last Update Submit

February 18, 2020

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects rated a treatment success based on the Investigator's Global Assessment (IGA)

    The primary efficacy endpoint will be the percentage of subjects with IGA treatment success at End of Study (EOS) where EOS is the subject's last completed post-Baseline visit (Day 29).

    Day 29

Secondary Outcomes (3)

  • Percentage of subjects rated a treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)

    Day 29

  • Change from Baseline in pruritus score

    Day 29

  • IGA "treatment success" at Day 15

    Day 15

Study Arms (2)

Drug: 188-0551 Spray

EXPERIMENTAL

188-0551 Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks

Drug: 188-0551 Spray

Vehicle Spray

PLACEBO COMPARATOR

Vehicle Spray applied topically twice daily to psoriatic lesions within the assigned treatment area for up to four (4) weeks

Drug: Vehicle Spray

Interventions

188-0551 SprayDRUG

Topical Spray containing active drug

Drug: 188-0551 Spray
Vehicle SprayDRUG

Topical Spray containing no active drug

Vehicle Spray

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is male or non-pregnant female and is at least 18 years of age at time of informed consent.
  • Subject has provided written informed consent.
  • 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).
  • Subject has moderate to severe plaque psoriasis.
  • Subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
  • Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at the Baseline Visit.

You may not qualify if:

  • Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
  • Subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis.
  • Subject has palmar/plantar psoriasis.
  • Subject is pregnant, lactating, or is planning to become pregnant during the study.
  • Subject is currently enrolled in an investigational drug or device study.
  • Subject has been previously enrolled in this study and treated with a test article.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Site 06

Fort Smith, Arkansas, 72916, United States

Location

Site 09

Fountain Valley, California, 92708, United States

Location

Site 07

Fremont, California, 94538, United States

Location

Site 02

Aventura, Florida, 33180, United States

Location

Site 04

Brandon, Florida, 33544, United States

Location

Site 01

Largo, Florida, 33770, United States

Location

Site 05

North Miami Beach, Florida, 33162, United States

Location

Site 08

Albany, Indiana, 47150, United States

Location

Site 03

Plainfield, Indiana, 46168, United States

Location

Site 11

Louisville, Kentucky, 40241, United States

Location

Site 12

Metairie, Louisiana, 70006, United States

Location

Site 10

Fountain Inn, South Carolina, 92708, United States

Location

Study Officials

  • Tony Andrasfay

    Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2018

First Posted

November 29, 2018

Study Start

November 26, 2018

Primary Completion

August 27, 2019

Study Completion

August 27, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(12)