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BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

NCT02684357 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 577

Last updated 2021-08-23

Study results available
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Summary

This is a randomized double blind, double dummy, placebo and active comparator controlled, parallel design study that is being performed to assess the safety and efficacy of risankizumab (BI 655066) to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

Conditions

Interventions

DRUG

risankizumab

Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

DRUG

ustekinumab

Ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection

DRUG

placebo for risankizumab

Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection

DRUG

placebo for ustekinumab

Placebo for ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-12-31
Completion
2017-09-30

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Entities

Drugs
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 NCT02684357 on ClinicalTrials.gov