NCT04999839

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Moderate to Severe Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	NDI-034858 study drug	NDI-034858 2 mg oral capsules.
DRUG	NDI-034858 study drug	NDI-034858 5 mg oral capsules.
DRUG	NDI-034858 study drug	NDI-034858 15 mg oral capsules.
DRUG	NDI-034858 study drug	NDI-034858 30 mg (2\*15 mg) oral capsules.
OTHER	Placebo	Placebo matched to NDI-034858 oral capsules.

Timeline

• Start date: 2021-08-11
• Primary completion: 2022-08-19
• Completion: 2022-09-12
• First posted: 2021-08-11
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

69 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study