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

Study Purpose

The objectives of this study are 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 participants with moderate to severe plaque psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03875508
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

AbbVie Inc.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

Experimental: Risankizumab autoinjector

Participants will be self-administering risankizumab using a pre-filled autoinjector

Interventions

Drug: - Risankizumab

Risankizumab to be injected subcutaneously (SC)

Device: - Autoinjector

Single dose pre-filled autoinjector containing risankizumab for SC injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Not yet recruiting

Address

UAB Department of Dermatology /ID# 210384

Birmingham, Alabama, 35233

Advanced Research Associates /ID# 210634, Glendale, Arizona

Status

Recruiting

Address

Advanced Research Associates /ID# 210634

Glendale, Arizona, 85308

Cognitive Clinical Trials /ID# 210770, Scottsdale, Arizona

Status

Recruiting

Address

Cognitive Clinical Trials /ID# 210770

Scottsdale, Arizona, 85258-4446

Hot Springs, Arkansas

Status

Recruiting

Address

Burke Pharmaceutical Research /ID# 211386

Hot Springs, Arkansas, 71913-6404

Bakersfield, California

Status

Recruiting

Address

Bakersfield Derma & Skin Cance /ID# 210773

Bakersfield, California, 93309

Encino, California

Status

Recruiting

Address

Encino Research Center / T. Jo /ID# 211735

Encino, California, 91436

Tien Q Nguyen MD, Inc /ID# 210775, Fountain Valley, California

Status

Recruiting

Address

Tien Q Nguyen MD, Inc /ID# 210775

Fountain Valley, California, 92708-3701

Irvine, California

Status

Not yet recruiting

Address

University of California Irvine /ID# 210776

Irvine, California, 92697-1385

UC Davis, Dermatology /ID# 210411, Sacramento, California

Status

Recruiting

Address

UC Davis, Dermatology /ID# 210411

Sacramento, California, 95816

Dermatology Physicians of CT /ID# 210637, Shelton, Connecticut

Status

Recruiting

Address

Dermatology Physicians of CT /ID# 210637

Shelton, Connecticut, 06484-6211

Coral Gables, Florida

Status

Recruiting

Address

Florida Academic Centers Research /ID# 210337

Coral Gables, Florida, 33134

Naples, Florida

Status

Recruiting

Address

Medallion Clinical Research Institute, LLC /ID# 210329

Naples, Florida, 34102

Renstar Medical Research /ID# 210878, Ocala, Florida

Status

Recruiting

Address

Renstar Medical Research /ID# 210878

Ocala, Florida, 34470

Kansas City Dermatology PA /ID# 211493, Overland Park, Kansas

Status

Recruiting

Address

Kansas City Dermatology PA /ID# 211493

Overland Park, Kansas, 66215

DermAssociates /ID# 210838, Rockville, Maryland

Status

Recruiting

Address

DermAssociates /ID# 210838

Rockville, Maryland, 20850

Tufts Medical Center /ID# 210640, Boston, Massachusetts

Status

Not yet recruiting

Address

Tufts Medical Center /ID# 210640

Boston, Massachusetts, 02111

Bay City, Michigan

Status

Recruiting

Address

Great Lakes Research Group,Inc /ID# 210192

Bay City, Michigan, 48706

Somerset Skin Centre /ID# 211596, Troy, Michigan

Status

Recruiting

Address

Somerset Skin Centre /ID# 211596

Troy, Michigan, 48084

Central Dermatology, PC /ID# 210301, Saint Louis, Missouri

Status

Recruiting

Address

Central Dermatology, PC /ID# 210301

Saint Louis, Missouri, 63117

Dover, New Hampshire

Status

Recruiting

Address

Northeast Dermatology Associates /ID# 211429

Dover, New Hampshire, 03820-2454

Medication Management, LLC /ID# 213217, Greensboro, North Carolina

Status

Recruiting

Address

Medication Management, LLC /ID# 213217

Greensboro, North Carolina, 27408

Rapid Medical Research, INC /ID# 210207, Cleveland, Ohio

Status

Not yet recruiting

Address

Rapid Medical Research, INC /ID# 210207

Cleveland, Ohio, 44122

Oregon Medical Res Center PC /ID# 210334, Portland, Oregon

Status

Recruiting

Address

Oregon Medical Res Center PC /ID# 210334

Portland, Oregon, 97223

University of Pittsburgh MC /ID# 210839, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh MC /ID# 210839

Pittsburgh, Pennsylvania, 15260

Center for Clinical Studies /ID# 211565, Cypress, Texas

Status

Recruiting

Address

Center for Clinical Studies /ID# 211565

Cypress, Texas, 77433

Center for Clinical Studies /ID# 210362, Houston, Texas

Status

Recruiting

Address

Center for Clinical Studies /ID# 210362

Houston, Texas, 77004

Suzanne Bruce and Associates /ID# 212210, Houston, Texas

Status

Recruiting

Address

Suzanne Bruce and Associates /ID# 212210

Houston, Texas, 77056

Pflugerville, Texas

Status

Recruiting

Address

Austin Center for Clinical Research /ID# 212203

Pflugerville, Texas, 78660

Premier Clinical Research /ID# 212209, Spokane, Washington

Status

Recruiting

Address

Premier Clinical Research /ID# 212209

Spokane, Washington, 99202

Froedtert Mem Lutheran Hosp /ID# 210194, Milwaukee, Wisconsin

Status

Recruiting

Address

Froedtert Mem Lutheran Hosp /ID# 210194

Milwaukee, Wisconsin, 53226

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