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

Phase 2

Completed

Conditions: Psoriasis

Interventions: Drug: PPC-06 400 mg BID
Drug: Placebo
Drug: PPC-06 400 mg QD
Drug: PPC-06 600 mg

Registration Number: NCT03421197

Lead Sponsor: Dr. Reddy's Laboratories Limited

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 426

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPC-06 400 mg BID	PPC-06 400 mg BID	Tepilamide Fumarate 400 mg twice per day
Placebo BID	Placebo	White placebo tablet to mimic Tepilamide Fumarate
PPC-06 400 mg QD	PPC-06 400 mg QD	Tepilamide Fumarate 400 mg once per day
PPC-06 600 mg BID	PPC-06 600 mg	Tepilamide Fumarate 600 mg twice per day

Primary Outcome Measures

Name	Time	Method
Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24	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.
Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1	End of Week 24	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (74): Site 133
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Fountain Valley, California, United States
Site 182
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Los Angeles, California, United States
Site 145
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Hialeah, Florida, United States
Site 154
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Pembroke Pines, Florida, United States
Site 176
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Los Angeles, California, United States
Site 178
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Los Angeles, California, United States
Site 137
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Clearwater, Florida, United States
Site 124
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Savannah, Georgia, United States
Site 122
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Nampa, Idaho, United States
Site 159
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Sugar Land, Texas, United States
Site 144
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Glendale, Arizona, United States
Site 170
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Tempe, Arizona, United States
Site 125
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Rogers, Arkansas, United States
Site 157
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Bryant, Arkansas, United States
Site 119
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Baton Rouge, Louisiana, United States
Site 141
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San Diego, California, United States
Site 149
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Miami, Florida, United States
Site 174
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Miami, Florida, United States
Site 164
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Miami, Florida, United States
Site 180-
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Las Vegas, Nevada, United States
Site 123
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Miami, Florida, United States
Site 181
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Hialeah, Florida, United States
Site 127
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Las Vegas, Nevada, United States
Site 106
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San Antonio, Texas, United States
Site 101
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San Antonio, Texas, United States
Site 139
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Overland Park, Kansas, United States
Site 167
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Phoenix, Arizona, United States
Site 158
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Phoenix, Arizona, United States
Site 109
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Omaha, Nebraska, United States
Site 150
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Tampa, Florida, United States
Site 113
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Tampa, Florida, United States
Site 107
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Fremont, California, United States
Site 121
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Fresno, California, United States
Site 153
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Fullerton, California, United States
Site 156
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Murrieta, California, United States
Site 130
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Coral Gables, Florida, United States
Site 155
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Santa Rosa, California, United States
Site 143
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Hialeah, Florida, United States
Site 105
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Miami, Florida, United States
Site 112
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Miramar, Florida, United States
Site 172
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New Port Richey, Florida, United States
Site 152
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Orange Park, Florida, United States
Site 110
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Sweetwater, Florida, United States
Site 132
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Marietta, Georgia, United States
Site 179
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Wheaton, Illinois, United States
Site 171
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New Albany, Indiana, United States
Site 115
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Indianapolis, Indiana, United States
Site 128
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Clinton Township, Michigan, United States
Site 129
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Fridley, Minnesota, United States
Site 177
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New York, New York, United States
Site 103
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New York, New York, United States
Site 161
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Rochester, New York, United States
Site 104
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New York, New York, United States
Site 146
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Stony Brook, New York, United States
Site 108
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High Point, North Carolina, United States
Site 116
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Wilmington, North Carolina, United States
Site 118
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Beachwood, Ohio, United States
Site 114
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Johnston, Rhode Island, United States
Site 169
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Cincinnati, Ohio, United States
Site 134
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Mount Pleasant, South Carolina, United States
Site 100
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Rapid City, South Dakota, United States
Site 162
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Houston, Texas, United States
Site 102
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Houston, Texas, United States
Site 160
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Bellaire, Texas, United States
Site 136
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Orem, Utah, United States
Site 166
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Norfolk, Virginia, United States
Site 135
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Burien, Washington, United States
Site 147
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Spokane, Washington, United States
Site 165
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Louisville, Kentucky, United States
Site 131
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Louisville, Kentucky, United States
Site 142
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Louisville, Kentucky, United States
Site 126
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New Orleans, Louisiana, United States
Site 111
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Kansas City, Missouri, United States
Site 148
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Austin, Texas, United States