A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis

NCT01700985 | Completed Phase 2 Results

• 1 other identifier: 122-0551-203
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive days.

Conditions

Psoriasis; Plaque Psoriasis

Keywords

psoriasis; plaque psoriasis; 122-0551; steroid

Outcome Measures

Primary Outcomes (1)

• Change in Overall Disease Severity (ODS) Score

  The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.

  baseline and Day 15 (End of Study - EOS)

Secondary Outcomes (5)

• ODS "Treatment Success" at Day 8 and Day 15

  baseline, Day 8, and Day 15

• ODS "Improved" at Day 8 and Day 15

  baseline, Day 8, and Day 15

• "Treatment Success" for Clinical Signs and Symptoms of Psoriasis

  baseline, Day 8 and Day 15

• "Improved" for Clinical Signs and Symptoms of Psoriasis

  baseline, Day 8 and Day 15

• Change in % Body Surface Area (BSA) With Psoriasis

  baseline, Day 8 and Day 15

Study Arms (2)

122-0551

EXPERIMENTAL

Drug: 122-0551

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

122-0551 DRUG

Applied twice daily for two weeks

122-0551

Vehicle DRUG

Applied twice daily for two weeks

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a clinical diagnosis of stable plaque psoriasis
• Subject has an ODS score for the Treatment Area of 3 or 4 at study start

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 used any phototherapy, photo-chemotherapy or systemic corticosteroid therapy within 30 days prior to study start
• Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to study start
• Subject has used any systemic biologic therapy for the treatment of psoriasis within 5 half-lives of the biologic prior to study start
• Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start
• Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to study start
• Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start
• Subject is currently using lithium or Plaquenil (hydroxychloroquine)
• Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE (e.g., lisinopril) inhibitor at a dose that has not been stabilized
• 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 used an investigational drug or investigational device treatment within 30 days prior to study start
• Subject has been previously enrolled in this study and treated with a test article

Sponsors & Collaborators

• Therapeutics, Inc.: lead

Study Sites (2)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Research, Therapeutics Inc.
• Organization: Therapeutics Inc.

clinicalresearch@therapeuticsinc.com

858-571-1800

Study Officials

• Syd Dromgoole, PhD

  Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 4, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 25, 2018
• Results First Posted: October 25, 2018

Record last verified: 2018-08

Locations

US (2)