Clinical trial NCT03421197: A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Achieving Psoriasis Area and Severity Index (PASI) - 75 at the End of Week 24
timeFrame: End of Week 24
measure: Achieving the Investigator's Global Assessment (IGA) Score of 0 or 1
timeFrame: End of Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Site 144
state: Arizona
city: Phoenix
country: United States
facility: Site 167
state: Arizona
city: Phoenix
country: United States
facility: Site 158
state: Arizona
city: Tempe
country: United States
facility: Site 170
state: Arizona
city: Bryant
country: United States
facility: Site 157
state: Arkansas
city: Rogers
country: United States
facility: Site 125
state: Arkansas
city: Fountain Valley
country: United States
facility: Site 133
state: California
city: Fremont
country: United States
facility: Site 107
state: California
city: Fresno
country: United States
facility: Site 121
state: California
city: Fullerton
country: United States
facility: Site 153
state: California
city: Los Angeles
country: United States
facility: Site 176
state: California
city: Los Angeles
country: United States
facility: Site 178
state: California
city: Los Angeles
country: United States
facility: Site 182
state: California
city: Murrieta
country: United States
facility: Site 156
state: California
city: San Diego
country: United States
facility: Site 141
state: California
city: Santa Rosa
country: United States
facility: Site 155
state: California
city: Clearwater
country: United States
facility: Site 137
state: Florida
city: Coral Gables
country: United States
facility: Site 130
state: Florida
city: Hialeah
country: United States
facility: Site 143
state: Florida
city: Hialeah
country: United States
facility: Site 145
state: Florida
city: Hialeah
country: United States
facility: Site 181
state: Florida
city: Miami
country: United States
facility: Site 149
state: Florida
city: Miami
country: United States
facility: Site 105
state: Florida
city: Miami
country: United States
facility: Site 174
state: Florida
city: Miami
country: United States
facility: Site 164
state: Florida
city: Miami
country: United States
facility: Site 123
state: Florida
city: Miramar
country: United States
facility: Site 112
state: Florida
city: New Port Richey
country: United States
facility: Site 172
state: Florida
city: Orange Park
country: United States
facility: Site 152
state: Florida
city: Pembroke Pines
country: United States
facility: Site 154
state: Florida
city: Sweetwater
country: United States
facility: Site 110
state: Florida
city: Tampa
country: United States
facility: Site 150
state: Florida
city: Tampa
country: United States
facility: Site 113
state: Florida
city: Marietta
country: United States
facility: Site 132
state: Georgia
city: Savannah
country: United States
facility: Site 124
state: Georgia
city: Nampa
country: United States
facility: Site 122
state: Idaho
city: Wheaton
country: United States
facility: Site 179
state: Illinois
city: Indianapolis
country: United States
facility: Site 115
state: Indiana
city: New Albany
country: United States
facility: Site 171
state: Indiana
city: Overland Park
country: United States
facility: Site 139
state: Kansas
city: Louisville
country: United States
facility: Site 165
state: Kentucky
city: Louisville
country: United States
facility: Site 131
state: Kentucky
city: Louisville
country: United States
facility: Site 142
state: Kentucky
city: Baton Rouge
country: United States
facility: Site 119
state: Louisiana
city: New Orleans
country: United States
facility: Site 126
state: Louisiana
city: Clinton Township
country: United States
facility: Site 128
state: Michigan
city: Fridley
country: United States
facility: Site 129
state: Minnesota
city: Kansas City
country: United States
facility: Site 111
state: Missouri
city: Omaha
country: United States
facility: Site 109
state: Nebraska
city: Las Vegas
country: United States
facility: Site 127
state: Nevada
city: Las Vegas
country: United States
facility: Site 180-
state: Nevada
city: New York
country: United States
facility: Site 103
state: New York
city: New York
country: United States
facility: Site 177
state: New York
city: New York
country: United States
facility: Site 104
state: New York
city: Rochester
country: United States
facility: Site 161
state: New York
city: Stony Brook
country: United States
facility: Site 146
state: New York
city: High Point
country: United States
facility: Site 108
state: North Carolina
city: Wilmington
country: United States
facility: Site 116
state: North Carolina
city: Beachwood
country: United States
facility: Site 118
state: Ohio
city: Cincinnati
country: United States
facility: Site 169
state: Ohio
city: Johnston
country: United States
facility: Site 114
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Site 134
state: South Carolina
city: Rapid City
country: United States
facility: Site 100
state: South Dakota
city: Austin
country: United States
facility: Site 148
state: Texas
city: Bellaire
country: United States
facility: Site 160
state: Texas
city: Houston
country: United States
facility: Site 162
state: Texas
city: Houston
country: United States
facility: Site 102
state: Texas
city: San Antonio
country: United States
facility: Site 106
state: Texas
city: San Antonio
country: United States
facility: Site 101
state: Texas
city: Sugar Land
country: United States
facility: Site 159
state: Texas
city: Orem
country: United States
facility: Site 136
state: Utah
city: Norfolk
country: United States
facility: Site 166
state: Virginia
city: Burien
country: United States
facility: Site 135
state: Washington
city: Spokane
country: United States
facility: Site 147
state: Washington
Study officials:
affiliation: Dr. Reddy's Laboratories, Inc
name: Srinivas Sidgiddi, MD
role: STUDY_DIRECTOR
References: