Status:
COMPLETED
A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-sever...
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 subj...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT03421197
Start Date
January 25 2018
End Date
March 30 2020
Last Update
April 1 2022
Active Locations (74)
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1
Site 144
Glendale, Arizona, United States, 85308
2
Site 167
Phoenix, Arizona, United States, 85018
3
Site 158
Phoenix, Arizona, United States, 85053
4
Site 170
Tempe, Arizona, United States, 85283