A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Study Purpose

The objective of this study is to evaluate efficacy and safety of risankizumab using a new formulation compared with placebo for treatment of 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.

NCT03875482
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 Puerto Rico, United States
Conditions

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

Psoriasis
Arms & Interventions

Arms

Experimental: Risankizumab

Participants randomized to receive risankizumab

Experimental: Placebo

Participants randomized to receive placebo for risankizumab

Interventions

Drug: - Risankizumab

Risankizumab is administered as subcutaneous (SC) injection

Drug: - Placebo

Placebo for risankizumab is administered as subcutaneous (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

Recruiting

Address

Total Skin and Beauty Derm Ctr /ID# 210366

Birmingham, Alabama, 35205

Phoenix, Arizona

Status

Recruiting

Address

Alliance Dermatology and MOHs /ID# 210645

Phoenix, Arizona, 85032

Hull Dermatology, PA /ID# 210305, Rogers, Arkansas

Status

Recruiting

Address

Hull Dermatology, PA /ID# 210305

Rogers, Arkansas, 72758

Anaheim Clinical Trials LLC /ID# 212559, Anaheim, California

Status

Recruiting

Address

Anaheim Clinical Trials LLC /ID# 212559

Anaheim, California, 92801

Wallace Medical Group, Inc. /ID# 210403, Beverly Hills, California

Status

Recruiting

Address

Wallace Medical Group, Inc. /ID# 210403

Beverly Hills, California, 90211

Dermatology Res. Assoc., CA /ID# 210402, Los Angeles, California

Status

Recruiting

Address

Dermatology Res. Assoc., CA /ID# 210402

Los Angeles, California, 90045

Sacramento, California

Status

Recruiting

Address

Integrative Skin Science and Research /ID# 212551

Sacramento, California, 95815-4500

Mosaic Dermatology /ID# 210780, Santa Monica, California

Status

Recruiting

Address

Mosaic Dermatology /ID# 210780

Santa Monica, California, 90404

Skin Care Research, LLC /ID# 210514, Boca Raton, Florida

Status

Recruiting

Address

Skin Care Research, LLC /ID# 210514

Boca Raton, Florida, 33486-2269

ACCEL Research Sites /ID# 212709, DeLand, Florida

Status

Recruiting

Address

ACCEL Research Sites /ID# 212709

DeLand, Florida, 32720

Lake City, Florida

Status

Recruiting

Address

Multi-Speciality Research Associates /ID# 211625

Lake City, Florida, 32055-8835

GSI Clinical Research, LLC /ID# 210330, Margate, Florida

Status

Recruiting

Address

GSI Clinical Research, LLC /ID# 210330

Margate, Florida, 33063

Suncoast Clinical Research /ID# 210874, New Port Richey, Florida

Status

Recruiting

Address

Suncoast Clinical Research /ID# 210874

New Port Richey, Florida, 34652

Ormond Beach, Florida

Status

Recruiting

Address

Ormond Medical Arts Pharmaceutical Research Center /ID# 212781

Ormond Beach, Florida, 32174-6302

Progressive Medical Research /ID# 210877, Port Orange, Florida

Status

Recruiting

Address

Progressive Medical Research /ID# 210877

Port Orange, Florida, 32127

Precision Clinical Research /ID# 212921, Sunrise, Florida

Status

Recruiting

Address

Precision Clinical Research /ID# 212921

Sunrise, Florida, 33351-7311

Sweetwater, Florida

Status

Recruiting

Address

Lenus Research & Medical Group /ID# 212584

Sweetwater, Florida, 33172

Treasure Valley Dermatology /ID# 212707, Boise, Idaho

Status

Recruiting

Address

Treasure Valley Dermatology /ID# 212707

Boise, Idaho, 83713-0997

Normal, Illinois

Status

Recruiting

Address

Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562

Normal, Illinois, 61761

Plainfield, Indiana

Status

Recruiting

Address

The Indiana Clinical Trials Center /ID# 210205

Plainfield, Indiana, 46168

Forefront Dermatology /ID# 210520, Louisville, Kentucky

Status

Recruiting

Address

Forefront Dermatology /ID# 210520

Louisville, Kentucky, 40202-2862

DS Research /ID# 210272, Louisville, Kentucky

Status

Recruiting

Address

DS Research /ID# 210272

Louisville, Kentucky, 40241-6162

David Fivenson, MD, PLC /ID# 210193, Ann Arbor, Michigan

Status

Recruiting

Address

David Fivenson, MD, PLC /ID# 210193

Ann Arbor, Michigan, 48103

Clarkston Skin Research /ID# 210197, Clarkston, Michigan

Status

Recruiting

Address

Clarkston Skin Research /ID# 210197

Clarkston, Michigan, 48346

Henry Ford Medical Center /ID# 211598, Detroit, Michigan

Status

Recruiting

Address

Henry Ford Medical Center /ID# 211598

Detroit, Michigan, 48202-3046

Cleaver Dermatology /ID# 210300, Kirksville, Missouri

Status

Recruiting

Address

Cleaver Dermatology /ID# 210300

Kirksville, Missouri, 63501-5362

Omaha, Nebraska

Status

Recruiting

Address

Advanced Dermatology of the Midlands /ID# 212763

Omaha, Nebraska, 68144-1105

Skin Specialists, PC /ID# 211490, Omaha, Nebraska

Status

Recruiting

Address

Skin Specialists, PC /ID# 211490

Omaha, Nebraska, 68144

Lebanon, New Hampshire

Status

Not yet recruiting

Address

Darmouth-Hitchcock Medical Cen /ID# 210644

Lebanon, New Hampshire, 03756

Psoriasis Treatment Ctr NJ /ID# 210837, East Windsor, New Jersey

Status

Recruiting

Address

Psoriasis Treatment Ctr NJ /ID# 210837

East Windsor, New Jersey, 08520

Hackensack, New Jersey

Status

Recruiting

Address

Skin Laser and Surgery Specialists /ID# 210208

Hackensack, New Jersey, 07601-1997

Stony Brook, New York

Status

Recruiting

Address

DermResearchCenter of NY, Inc. /ID# 210652

Stony Brook, New York, 11790

Wilmington, North Carolina

Status

Recruiting

Address

Wilmington Dermatology Center /ID# 210372

Wilmington, North Carolina, 28403

Oklahoma City, Oklahoma

Status

Recruiting

Address

Lynn Health Science Institute (LHSI) /ID# 213216

Oklahoma City, Oklahoma, 73112

Clinical Partners, LLC /ID# 210642, Johnston, Rhode Island

Status

Recruiting

Address

Clinical Partners, LLC /ID# 210642

Johnston, Rhode Island, 02919

Fountain Inn, South Carolina

Status

Recruiting

Address

Palmetto Clinical Trial Services /ID# 210368

Fountain Inn, South Carolina, 29644-1928

Mount Pleasant, South Carolina

Status

Recruiting

Address

Coastal Carolina Research Ctr /ID# 213069

Mount Pleasant, South Carolina, 29464

Arlington, Texas

Status

Recruiting

Address

Arlington Research Center, Inc /ID# 210344

Arlington, Texas, 76011

Houston, Texas

Status

Recruiting

Address

Center for Clinical Studies - Houston (Binz) /ID# 210361

Houston, Texas, 77004-8097

San Antonio, Texas

Status

Recruiting

Address

Progressive Clinical Research /ID# 210359

San Antonio, Texas, 78229

Acclaim Dermatology /ID# 212252, Sugar Land, Texas

Status

Recruiting

Address

Acclaim Dermatology /ID# 212252

Sugar Land, Texas, 77479-2645

International Sites

Dr. Samuel Sanchez, PSC /ID# 211142, Caguas, Puerto Rico

Status

Recruiting

Address

Dr. Samuel Sanchez, PSC /ID# 211142

Caguas, , 00727

Rio Piedras, Puerto Rico

Status

Recruiting

Address

Pan American Center for Oncology Trials, LLC /ID# 212445

Rio Piedras, , 00935

San Juan, Puerto Rico

Status

Recruiting

Address

Clinical Research Puerto Rico /ID# 211144

San Juan, , 0090

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