CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 259 enrolled
Drug / intervention
NDI-034858 study drug +4 moredrug
Likely dose
NDI-034858 study drug 2 mgfrom 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.

Search/NCT04999839
NCT04999839Phase 2Completed
CompareCT.gov

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

Takeda·interventional·Posted Aug 11, 2021·Updated Sep 28, 2023

In Brief

A Phase 2 clinical trial evaluating NDI-034858 study drug and Placebo for Moderate to Severe Plaque Psoriasis. Completed, enrolled 259 participants across 69 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate to Severe Plaque Psoriasis
CountriesCanada, United States
CollaboratorsInnovaderm Research Inc., Nimbus Lakshmi, Inc.

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedAug 11, 2021
Enrollment StartAug 11, 2021
Primary CompletionAug 19, 2022
Study CompletionSep 12, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.9 years ago

Interventions

NDI-034858 study drugdrug

NDI-034858 2 mg oral capsules.

NDI-034858 study drugdrug

NDI-034858 5 mg oral capsules.

NDI-034858 study drugdrug

NDI-034858 15 mg oral capsules.

NDI-034858 study drugdrug

NDI-034858 30 mg (2\*15 mg) oral capsules.

Placeboother

Placebo matched to NDI-034858 oral capsules.