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

• Status: Completed
• Trial end date: 2020-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited

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).