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

NCT03421197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2022-04-01

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Srinivas Sidgiddi, MD · Dr. Reddy's Laboratories, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2020-03-30
Completion
2020-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03421197 on ClinicalTrials.gov