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Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:
A Phase 2b, Randomized, Multicenter, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects With Moderate to Severe Plaque Psoriasis

Clinical Trial Summary

This is a Phase 2b, randomized, multicenter, double-blind, placebo-controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in participants with moderate to severe plaque psoriasis. This study will also evaluate the plasma concentrations of NDI-034858 and explore the immune response to NDI-034858 in participants with moderate to severe plaque psoriasis.

Clinical Trial Description

Approximately 259 male and female participants, aged 18 to 70 years (inclusive) were enrolled in this study. Participants were randomized to receive either one of the four doses of NDI-034858, or placebo on Day 1. The goal was to have approximately 50 participants randomized per treatment group (1:1:1:1:1 ratio) on Day 1. During the treatment period, NDI-034858 or placebo was orally administered QD for 12 weeks. The 12 week treatment period was followed by a 4-week safety follow-up period. ;

Study Design

Related Conditions & MeSH terms

  • Moderate to Severe Plaque Psoriasis
  • Psoriasis
Clinical Trial Details
NCT number NCT04999839
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 2
Start date August 11, 2021
Completion date September 12, 2022
View Details
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