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A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

NCT ID: NCT03875508

Last Updated: 2021-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2020-08-25

Brief Summary

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The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.

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A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

NCT03671148

Psoriatic Arthritis (PsA)
ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

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This was a Phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-AI combination product. The study included a 30-day screening period with study visits at Weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (Week 48). Study drug dosing consisted of 4 self-administered doses given subcutaneously on Weeks 0, 4, 16, and 28. Dosing on Weeks 4 and 16 was self-administered at home.

Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Risankizumab

Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Risankizumab to be injected subcutaneously (SC)

Autoinjector

Intervention Type DEVICE

Single dose pre-filled autoinjector containing risankizumab for SC injection

Interventions

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Risankizumab

Risankizumab to be injected subcutaneously (SC)

Intervention Type DRUG

Autoinjector

Single dose pre-filled autoinjector containing risankizumab for SC injection

Intervention Type DEVICE

Other Intervention Names

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ABBV-066 BI 655066

Eligibility Criteria

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Inclusion Criteria

* Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit
* Participant meets following disease activity criteria:

* Stable moderate to severe chronic plaque psoriasis, defined as ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 12 at Screening and baseline visit
* Candidate for systemic therapy as assessed by the investigator

Exclusion Criteria

* Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis
* Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
* Participant has previous exposure to risankizumab
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Advanced Research Associates /ID# 210634

Glendale, Arizona, United States

Site Status

Cognitive Clinical Trials /ID# 210770

Scottsdale, Arizona, United States

Site Status

Burke Pharmaceutical Research /ID# 211386

Hot Springs, Arkansas, United States

Site Status

Bakersfield Derma & Skin Cance /ID# 210773

Bakersfield, California, United States

Site Status

Encino Research Center / T. Jo /ID# 211735

Encino, California, United States

Site Status

Tien Q Nguyen MD, Inc /ID# 210775

Fountain Valley, California, United States

Site Status

UC Davis Health /ID# 210411

Sacramento, California, United States

Site Status

Dermatology Physicians of CT /ID# 210637

Shelton, Connecticut, United States

Site Status

Florida Academic Centers Research /ID# 210337

Coral Gables, Florida, United States

Site Status

Medallion Clinical Research Institute, LLC /ID# 210329

Naples, Florida, United States

Site Status

Renstar Medical Research /ID# 210878

Ocala, Florida, United States

Site Status

Epiphany Dermatology /ID# 211493

Overland Park, Kansas, United States

Site Status

DermAssociates /ID# 210838

Rockville, Maryland, United States

Site Status

Great Lakes Research, Inc. /ID# 210192

Bay City, Michigan, United States

Site Status

Somerset Skin Centre /ID# 211596

Troy, Michigan, United States

Site Status

Central Dermatology, PC /ID# 210301

St Louis, Missouri, United States

Site Status

AllCutis Research Inc /ID# 211429

Portsmouth, New Hampshire, United States

Site Status

Medication Management, LLC /ID# 213217

Greensboro, North Carolina, United States

Site Status

Oregon Medical Res Center PC /ID# 210334

Portland, Oregon, United States

Site Status

University of Pittsburgh MC /ID# 210839

Pittsburgh, Pennsylvania, United States

Site Status

Center for Clinical Studies /ID# 211565

Cypress, Texas, United States

Site Status

Center for Clinical Studies /ID# 210362

Houston, Texas, United States

Site Status

Suzanne Bruce and Associates /ID# 212210

Houston, Texas, United States

Site Status

Austin Institute for Clinical Research /ID# 212203

Pflugerville, Texas, United States

Site Status

Premier Clinical Research /ID# 212209

Spokane, Washington, United States

Site Status

Froedtert Mem Lutheran Hosp /ID# 210194

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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M16-005

Identifier Type: -

Identifier Source: org_study_id

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