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

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT03421197

Run by

Dr. Reddy's Laboratories Limited

People needed

426

Starts

2018-01-25

Expected to finish

2020-03-30

Last updated by the study team

2022-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• 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 144 — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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