A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)
NCT ID: NCT03421197
Last Updated: 2022-04-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
426 participants
INTERVENTIONAL
2018-01-25
2020-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PPC-06 400 mg QD
Tepilamide Fumarate 400 mg once per day
PPC-06 400 mg QD
Tepilamide Fumarate 400 mg tablet once per day
PPC-06 400 mg BID
Tepilamide Fumarate 400 mg twice per day
PPC-06 400 mg BID
Tepilamide Fumarate tablets 400 mg twice per day
PPC-06 600 mg BID
Tepilamide Fumarate 600 mg twice per day
PPC-06 600 mg
Tepilamide Fumarate tablets 600 mg twice per day
Placebo BID
White placebo tablet to mimic Tepilamide Fumarate
Placebo
white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Srinivas Sidgiddi, MD
Role: STUDY_DIRECTOR
Dr. Reddy's Laboratories, Inc
Locations
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Site 144
Glendale, Arizona, United States
Site 167
Phoenix, Arizona, United States
Site 158
Phoenix, Arizona, United States
Site 170
Tempe, Arizona, United States
Site 157
Bryant, Arkansas, United States
Site 125
Rogers, Arkansas, United States
Site 133
Fountain Valley, California, United States
Site 107
Fremont, California, United States
Site 121
Fresno, California, United States
Site 153
Fullerton, California, United States
Site 176
Los Angeles, California, United States
Site 178
Los Angeles, California, United States
Site 182
Los Angeles, California, United States
Site 156
Murrieta, California, United States
Site 141
San Diego, California, United States
Site 155
Santa Rosa, California, United States
Site 137
Clearwater, Florida, United States
Site 130
Coral Gables, Florida, United States
Site 143
Hialeah, Florida, United States
Site 145
Hialeah, Florida, United States
Site 181
Hialeah, Florida, United States
Site 149
Miami, Florida, United States
Site 105
Miami, Florida, United States
Site 174
Miami, Florida, United States
Site 164
Miami, Florida, United States
Site 123
Miami, Florida, United States
Site 112
Miramar, Florida, United States
Site 172
New Port Richey, Florida, United States
Site 152
Orange Park, Florida, United States
Site 154
Pembroke Pines, Florida, United States
Site 110
Sweetwater, Florida, United States
Site 150
Tampa, Florida, United States
Site 113
Tampa, Florida, United States
Site 132
Marietta, Georgia, United States
Site 124
Savannah, Georgia, United States
Site 122
Nampa, Idaho, United States
Site 179
Wheaton, Illinois, United States
Site 115
Indianapolis, Indiana, United States
Site 171
New Albany, Indiana, United States
Site 139
Overland Park, Kansas, United States
Site 165
Louisville, Kentucky, United States
Site 131
Louisville, Kentucky, United States
Site 142
Louisville, Kentucky, United States
Site 119
Baton Rouge, Louisiana, United States
Site 126
New Orleans, Louisiana, United States
Site 128
Clinton Township, Michigan, United States
Site 129
Fridley, Minnesota, United States
Site 111
Kansas City, Missouri, United States
Site 109
Omaha, Nebraska, United States
Site 127
Las Vegas, Nevada, United States
Site 180-
Las Vegas, Nevada, United States
Site 103
New York, New York, United States
Site 177
New York, New York, United States
Site 104
New York, New York, United States
Site 161
Rochester, New York, United States
Site 146
Stony Brook, New York, United States
Site 108
High Point, North Carolina, United States
Site 116
Wilmington, North Carolina, United States
Site 118
Beachwood, Ohio, United States
Site 169
Cincinnati, Ohio, United States
Site 114
Johnston, Rhode Island, United States
Site 134
Mt. Pleasant, South Carolina, United States
Site 100
Rapid City, South Dakota, United States
Site 148
Austin, Texas, United States
Site 160
Bellaire, Texas, United States
Site 162
Houston, Texas, United States
Site 102
Houston, Texas, United States
Site 106
San Antonio, Texas, United States
Site 101
San Antonio, Texas, United States
Site 159
Sugar Land, Texas, United States
Site 136
Orem, Utah, United States
Site 166
Norfolk, Virginia, United States
Site 135
Burien, Washington, United States
Site 147
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PPC-06-CD-004
Identifier Type: -
Identifier Source: org_study_id
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