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)
1 other identifier
interventional
426
1 country
74
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2018
74 active sites
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
First Submitted
Initial submission to the registry
January 23, 2018
CompletedStudy Start
First participant enrolled
January 25, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedResults Posted
Study results publicly available
May 11, 2021
CompletedApril 1, 2022
March 1, 2022
2.2 years
January 23, 2018
February 26, 2021
March 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques 4. 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
Study Arms (4)
PPC-06 400 mg QD
EXPERIMENTALTepilamide Fumarate 400 mg once per day
PPC-06 400 mg BID
EXPERIMENTALTepilamide Fumarate 400 mg twice per day
PPC-06 600 mg BID
EXPERIMENTALTepilamide Fumarate 600 mg twice per day
Placebo BID
PLACEBO COMPARATORWhite placebo tablet to mimic Tepilamide Fumarate
Interventions
Tepilamide Fumarate 400 mg tablet once per day
Tepilamide Fumarate tablets 400 mg twice per day
Tepilamide Fumarate tablets 600 mg twice per day
white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Eligibility Criteria
You may qualify if:
- 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):
- PASI score of ≥12
- Total body surface area (BSA) affected by plaque psoriasis of ≥10%
- IGA score of \>3
- Must be a candidate for phototherapy and/or systemic therapy for psoriasis.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
Site 144
Glendale, Arizona, 85308, United States
Site 167
Phoenix, Arizona, 85018, United States
Site 158
Phoenix, Arizona, 85053, United States
Site 170
Tempe, Arizona, 85283, United States
Site 157
Bryant, Arkansas, 72022, United States
Site 125
Rogers, Arkansas, 72758, United States
Site 133
Fountain Valley, California, 92708, United States
Site 107
Fremont, California, 94538, United States
Site 121
Fresno, California, 93720, United States
Site 153
Fullerton, California, 92835, United States
Site 176
Los Angeles, California, 90057, United States
Site 178
Los Angeles, California, 90057, United States
Site 182
Los Angeles, California, 90057, United States
Site 156
Murrieta, California, 92562, United States
Site 141
San Diego, California, 92123, United States
Site 155
Santa Rosa, California, 95405, United States
Site 137
Clearwater, Florida, 33761, United States
Site 130
Coral Gables, Florida, 33134, United States
Site 143
Hialeah, Florida, 33012, United States
Site 145
Hialeah, Florida, 33012, United States
Site 181
Hialeah, Florida, 33012, United States
Site 149
Miami, Florida, 33014, United States
Site 105
Miami, Florida, 33144, United States
Site 174
Miami, Florida, 33155, United States
Site 164
Miami, Florida, 33175, United States
Site 123
Miami, Florida, 33186, United States
Site 112
Miramar, Florida, 33027, United States
Site 172
New Port Richey, Florida, 34655, United States
Site 152
Orange Park, Florida, 32073, United States
Site 154
Pembroke Pines, Florida, 33028, United States
Site 110
Sweetwater, Florida, 33172, United States
Site 150
Tampa, Florida, 33609, United States
Site 113
Tampa, Florida, 33624, United States
Site 132
Marietta, Georgia, 30060, United States
Site 124
Savannah, Georgia, 31406, United States
Site 122
Nampa, Idaho, 83651, United States
Site 179
Wheaton, Illinois, 60189, United States
Site 115
Indianapolis, Indiana, 46256, United States
Site 171
New Albany, Indiana, 47150, United States
Site 139
Overland Park, Kansas, 66215, United States
Site 165
Louisville, Kentucky, 40202, United States
Site 131
Louisville, Kentucky, 40217, United States
Site 142
Louisville, Kentucky, 40241, United States
Site 119
Baton Rouge, Louisiana, 70808, United States
Site 126
New Orleans, Louisiana, 70115, United States
Site 128
Clinton Township, Michigan, 48038, United States
Site 129
Fridley, Minnesota, 55432, United States
Site 111
Kansas City, Missouri, 64114, United States
Site 109
Omaha, Nebraska, 68114, United States
Site 127
Las Vegas, Nevada, 89119, United States
Site 180-
Las Vegas, Nevada, 89148, United States
Site 103
New York, New York, 10012, United States
Site 177
New York, New York, 10075, United States
Site 104
New York, New York, 10155, United States
Site 161
Rochester, New York, 14623, United States
Site 146
Stony Brook, New York, 11790, United States
Site 108
High Point, North Carolina, 27262, United States
Site 116
Wilmington, North Carolina, 28405, United States
Site 118
Beachwood, Ohio, 44122, United States
Site 169
Cincinnati, Ohio, 45236, United States
Site 114
Johnston, Rhode Island, 02919, United States
Site 134
Mt. Pleasant, South Carolina, 29464, United States
Site 100
Rapid City, South Dakota, 57702, United States
Site 148
Austin, Texas, 78745, United States
Site 160
Bellaire, Texas, 77401, United States
Site 162
Houston, Texas, 77004, United States
Site 102
Houston, Texas, 77056, United States
Site 106
San Antonio, Texas, 78229, United States
Site 101
San Antonio, Texas, 78281, United States
Site 159
Sugar Land, Texas, 77479, United States
Site 136
Orem, Utah, 84058, United States
Site 166
Norfolk, Virginia, 23507, United States
Site 135
Burien, Washington, 98168, United States
Site 147
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Srinivas Sidgiddi, Sr Director, Clinical Development
- Organization
- Dr Reddy's Laboratories
Study Officials
- STUDY DIRECTOR
Srinivas Sidgiddi, MD
Dr. Reddy's Laboratories, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
January 23, 2018
First Posted
February 5, 2018
Study Start
January 25, 2018
Primary Completion
March 30, 2020
Study Completion
March 30, 2020
Last Updated
April 1, 2022
Results First Posted
May 11, 2021
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share