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

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)

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: PPC-06 400 mg QD; Drug: PPC-06 400 mg BID; Drug: PPC-06 600 mg; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 426
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Site 144
    • Phoenix, Arizona, United States, 85018
      • Site 167
    • Phoenix, Arizona, United States, 85053
      • Site 158
    • Tempe, Arizona, United States, 85283
      • Site 170
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Site 157
    • Rogers, Arkansas, United States, 72758
      • Site 125
  • California
    • Fountain Valley, California, United States, 92708
      • Site 133
    • Fremont, California, United States, 94538
      • Site 107
    • Fresno, California, United States, 93720
      • Site 121
    • Fullerton, California, United States, 92835
      • Site 153
    • Los Angeles, California, United States, 90057
      • Site 176
    • Los Angeles, California, United States, 90057
      • Site 178
    • Los Angeles, California, United States, 90057
      • Site 182
    • Murrieta, California, United States, 92562
      • Site 156
    • San Diego, California, United States, 92123
      • Site 141
    • Santa Rosa, California, United States, 95405
      • Site 155
  • Florida
    • Clearwater, Florida, United States, 33761
      • Site 137
    • Coral Gables, Florida, United States, 33134
      • Site 130
    • Hialeah, Florida, United States, 33012
      • Site 143
    • Hialeah, Florida, United States, 33012
      • Site 145
    • Hialeah, Florida, United States, 33012
      • Site 181
    • Miami, Florida, United States, 33014
      • Site 149
    • Miami, Florida, United States, 33144
      • Site 105
    • Miami, Florida, United States, 33155
      • Site 174
    • Miami, Florida, United States, 33175
      • Site 164
    • Miami, Florida, United States, 33186
      • Site 123
    • Miramar, Florida, United States, 33027
      • Site 112
    • New Port Richey, Florida, United States, 34655
      • Site 172
    • Orange Park, Florida, United States, 32073
      • Site 152
    • Pembroke Pines, Florida, United States, 33028
      • Site 154
    • Sweetwater, Florida, United States, 33172
      • Site 110
    • Tampa, Florida, United States, 33609
      • Site 150
    • Tampa, Florida, United States, 33624
      • Site 113
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Site 132
    • Savannah, Georgia, United States, 31406
      • Site 124
  • Idaho
    • Nampa, Idaho, United States, 83651
      • Site 122
  • Illinois
    • Wheaton, Illinois, United States, 60189
      • Site 179
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Site 115
    • New Albany, Indiana, United States, 47150
      • Site 171
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Site 139
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Site 165
    • Louisville, Kentucky, United States, 40217
      • Site 131
    • Louisville, Kentucky, United States, 40241
      • Site 142
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Site 119
    • New Orleans, Louisiana, United States, 70115
      • Site 126
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Site 128
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Site 129
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Site 111
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Site 109
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Site 127
    • Las Vegas, Nevada, United States, 89148
      • Site 180-
  • New York
    • New York, New York, United States, 10012
      • Site 103
    • New York, New York, United States, 10075
      • Site 177
    • New York, New York, United States, 10155
      • Site 104
    • Rochester, New York, United States, 14623
      • Site 161
    • Stony Brook, New York, United States, 11790
      • Site 146
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Site 108
    • Wilmington, North Carolina, United States, 28405
      • Site 116
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Site 118
    • Cincinnati, Ohio, United States, 45236
      • Site 169
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Site 114
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Site 134
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Site 100
  • Texas
    • Austin, Texas, United States, 78745
      • Site 148
    • Bellaire, Texas, United States, 77401
      • Site 160
    • Houston, Texas, United States, 77056
      • Site 102
    • Houston, Texas, United States, 77004
      • Site 162
    • San Antonio, Texas, United States, 78229
      • Site 106
    • San Antonio, Texas, United States, 78281
      • Site 101
    • Sugar Land, Texas, United States, 77479
      • Site 159
  • Utah
    • Orem, Utah, United States, 84058
      • Site 136
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Site 166
  • Washington
    • Burien, Washington, United States, 98168
      • Site 135
    • Spokane, Washington, United States, 99202
      • Site 147

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PPC-06 400 mg QD; Tepilamide Fumarate 400 mg once per day	Drug: PPC-06 400 mg QD; Tepilamide Fumarate 400 mg tablet once per day; Other Names: Tepilamide Fumarate 400 mg
EXPERIMENTAL: PPC-06 400 mg BID; Tepilamide Fumarate 400 mg twice per day	Drug: PPC-06 400 mg BID; Tepilamide Fumarate tablets 400 mg twice per day; Other Names: Tepilamide Fumarate 400 mg
EXPERIMENTAL: PPC-06 600 mg BID; Tepilamide Fumarate 600 mg twice per day	Drug: PPC-06 600 mg; Tepilamide Fumarate tablets 600 mg twice per day; Other Names: Tepilamide Fumarate 600 mg
PLACEBO_COMPARATOR: Placebo BID; White placebo tablet to mimic Tepilamide Fumarate	Drug: Placebo; white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets; Other Names: Placebo tablets twice per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2018
• Primary Completion (ACTUAL): March 30, 2020
• Study Completion (ACTUAL): March 30, 2020

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: PPC-06-CD-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No