Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04999839

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
See also
  Status Clinical Trial Phase
Completed NCT05020249 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT01202565 - Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice N/A
Recruiting NCT05258331 - Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With Psoriasis Phase 1
Withdrawn NCT03146247 - Analysis of the Pathogenesis of Itch in Response to Apremilast Therapy in Psoriasis Patients Phase 4
Recruiting NCT04367441 - Randomized, Double Blinded, Placebo Controlled, Single Dose Escalation Study of 608 in Healthy Subjects Phase 1
Completed NCT01644396 - An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation Phase 4
Completed NCT01622348 - Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis Phase 2
Recruiting NCT04566666 - To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis Phase 2
Active, not recruiting NCT05155098 - 2 Years Prospective Study to Collect Real-life Data on the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
Recruiting NCT06425549 - A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT01555606 - An Observational Study to Evaluate Patient-Reported Experiences of Living With Moderate-to-Severe Plaque Psoriasis Phase 4
Completed NCT02713295 - A Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece
Completed NCT05342428 - Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis Phase 1
Completed NCT04967508 - A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT00710580 - Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3
Recruiting NCT06109818 - Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis Phase 2
Completed NCT01077232 - Documentation of Humira in Psoriasis Patients in Routine Clinical Practice
Completed NCT03412747 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3
Withdrawn NCT04614298 - A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis Phase 4
Completed NCT02982005 - A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea Phase 3