A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)

Psoriasis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 24-Week Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate) Extended Release Tablets in Subjects With Moderate-to-Severe Plaque Psoriasis (AFFIRM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421197
• Other study ID #: PPC-06-CD-004
• Status: Completed
• Phase: Phase 2
• Start date: January 25, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: March 2022
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 (tepilamide fumarate) extended release in subjects with moderate-to-severe plaque psoriasis.

Description:

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 in subjects with moderate-to-severe plaque psoriasis. Study subjects will be enrolled at approximately 75 sites in the United States (US).

Approximately 400 subjects who meet the study entry criteria will be randomly assigned in a 1:1:1:1 ratio to 1 of the 4 treatment arms:

1. PPC-06 400 mg once daily (QD)

2. PPC-06 400 mg BID

3. PPC-06 600 mg BID

4. Placebo BID The maximum study duration for each subject will be approximately 29 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Generally healthy males or non-pregnant females age =18 years at the time of screening (or who have reached the state minimum legal age of consent).

• Stable, moderate-to-severe plaque psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator or as reported by the subject).

• Severity of disease meeting all 3 of the following criteria prior to randomization (at the Baseline [Day 0] visit):

1. PASI score of =12

2. Total body surface area (BSA) affected by plaque psoriasis of =10%

3. IGA score of >3

• Must be a candidate for phototherapy and/or systemic therapy for psoriasis.

Exclusion Criteria:

• Subjects with non-plaque psoriasis (ie, predominantly inverse, erythrodermic, predominantly guttate, or pustular psoriasis).

• Subjects with drug-induced psoriasis or subjects with drug-exacerbated psoriasis that has not resolved within 4 weeks prior to screening.

• Subjects who have received systemic non-biologic psoriasis therapy or phototherapy (including either oral and topical psoralen and ultraviolet A (PUVA) light therapy, ultraviolet B, or self-treatment with tanning beds or therapeutic sunbathing) within 4 weeks prior to the Baseline Visit.

• Subjects who had topical psoriasis treatment within the previous 2 weeks prior to the Baseline Visit.

• Subjects with history of concurrent or recent use of any biologic agent within the following washout periods prior to baseline visit:

• Etanercept - 35 days

• Infliximab, adalimumab - 12 weeks

• Ustekinumab - 24 weeks

• Any other biologic agent <5 half-lives prior to the Baseline Visit

• Subjects with history of use of any investigational drug within 28 days prior to randomization, or 5 pharmacokinetic/ pharmacodynamic half-lives (whichever is longer).

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• PPC-06 400 mg QD
Tepilamide Fumarate 400 mg tablet once per day
• PPC-06 400 mg BID
Tepilamide Fumarate tablets 400 mg twice per day
• PPC-06 600 mg
Tepilamide Fumarate tablets 600 mg twice per day
• Placebo
white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets

Locations

Country	Name	City	State
United States	Site 148	Austin	Texas
United States	Site 119	Baton Rouge	Louisiana
United States	Site 118	Beachwood	Ohio
United States	Site 160	Bellaire	Texas
United States	Site 157	Bryant	Arkansas
United States	Site 135	Burien	Washington
United States	Site 169	Cincinnati	Ohio
United States	Site 137	Clearwater	Florida
United States	Site 128	Clinton Township	Michigan
United States	Site 130	Coral Gables	Florida
United States	Site 133	Fountain Valley	California
United States	Site 107	Fremont	California
United States	Site 121	Fresno	California
United States	Site 129	Fridley	Minnesota
United States	Site 153	Fullerton	California
United States	Site 144	Glendale	Arizona
United States	Site 143	Hialeah	Florida
United States	Site 145	Hialeah	Florida
United States	Site 181	Hialeah	Florida
United States	Site 108	High Point	North Carolina
United States	Site 102	Houston	Texas
United States	Site 162	Houston	Texas
United States	Site 115	Indianapolis	Indiana
United States	Site 114	Johnston	Rhode Island
United States	Site 111	Kansas City	Missouri
United States	Site 127	Las Vegas	Nevada
United States	Site 180-	Las Vegas	Nevada
United States	Site 176	Los Angeles	California
United States	Site 178	Los Angeles	California
United States	Site 182	Los Angeles	California
United States	Site 131	Louisville	Kentucky
United States	Site 142	Louisville	Kentucky
United States	Site 165	Louisville	Kentucky
United States	Site 132	Marietta	Georgia
United States	Site 105	Miami	Florida
United States	Site 123	Miami	Florida
United States	Site 149	Miami	Florida
United States	Site 164	Miami	Florida
United States	Site 174	Miami	Florida
United States	Site 112	Miramar	Florida
United States	Site 134	Mount Pleasant	South Carolina
United States	Site 156	Murrieta	California
United States	Site 122	Nampa	Idaho
United States	Site 171	New Albany	Indiana
United States	Site 126	New Orleans	Louisiana
United States	Site 172	New Port Richey	Florida
United States	Site 103	New York	New York
United States	Site 104	New York	New York
United States	Site 177	New York	New York
United States	Site 166	Norfolk	Virginia
United States	Site 109	Omaha	Nebraska
United States	Site 152	Orange Park	Florida
United States	Site 136	Orem	Utah
United States	Site 139	Overland Park	Kansas
United States	Site 154	Pembroke Pines	Florida
United States	Site 158	Phoenix	Arizona
United States	Site 167	Phoenix	Arizona
United States	Site 100	Rapid City	South Dakota
United States	Site 161	Rochester	New York
United States	Site 125	Rogers	Arkansas
United States	Site 101	San Antonio	Texas
United States	Site 106	San Antonio	Texas
United States	Site 141	San Diego	California
United States	Site 155	Santa Rosa	California
United States	Site 124	Savannah	Georgia
United States	Site 147	Spokane	Washington
United States	Site 146	Stony Brook	New York
United States	Site 159	Sugar Land	Texas
United States	Site 110	Sweetwater	Florida
United States	Site 113	Tampa	Florida
United States	Site 150	Tampa	Florida
United States	Site 170	Tempe	Arizona
United States	Site 179	Wheaton	Illinois
United States	Site 116	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24	The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index (PASI-75) The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.	End of Week 24
Primary	Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1	The Percentage of subjects who achieve the Investigator's Global Assessment (IGA) score of clear or almost clear (IGA score 0 or 1); Score Grade Definition 0 Clear: No signs of psoriasis; Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling; Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions; Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques; Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions; A lower score on this scale at the end of the study indicates an improvement in the disease condition.	End of Week 24