NCT03421197

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	PPC-06 400 mg QD	Tepilamide Fumarate 400 mg tablet once per day
DRUG	PPC-06 400 mg BID	Tepilamide Fumarate tablets 400 mg twice per day
DRUG	PPC-06 600 mg	Tepilamide Fumarate tablets 600 mg twice per day
DRUG	Placebo	white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets

Timeline

• Start date: 2018-01-25
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2018-02-05
• Last updated: 2022-04-01
• Results posted: 2021-05-11

Locations

74 sites across 1 country: United States

Regulatory

• FDA-regulated drug study