At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 426 enrolled
Drug / intervention
PPC-06 400 mg QD +3 moredrug
Likely dose
PPC-06 400 mg QDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating PPC-06 400 mg QD, PPC-06 400 mg BID, and 2 other interventions for Psoriasis. Completed, enrolled 426 participants across 74 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedFeb 2018
Primary CompletionMar 2020
TodayJul 2026
First PostedFeb 5, 2018
Enrollment StartJan 25, 2018
Primary CompletionMar 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.4 years ago
Interventions
PPC-06 400 mg QDdrug
Tepilamide Fumarate 400 mg tablet once per day
PPC-06 400 mg BIDdrug
Tepilamide Fumarate tablets 400 mg twice per day
PPC-06 600 mgdrug
Tepilamide Fumarate tablets 600 mg twice per day
Placebodrug
white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets