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

NCT04999839 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2023-09-28

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Innovaderm Research Inc.

    collaborator OTHER

  • Nimbus Lakshmi, Inc.

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2022-08-19
Completion
2022-09-12
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04999839 on ClinicalTrials.gov