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Clinical Trial Details for A Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis


AbbVie
NCT ID: NCT03706040
Last Updated: September 20, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 2
  • Gender: All
  • Age: 12 Years - N/A
  • Condition: Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: AbbVie
  • Location: Not Provided

Official Title

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis

Purpose

The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adult and adolescent subjects.

Eligibility

Ages Eligible for Study

12 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

– adults who are ≥ 18 years old and, where locally permissible and approved, adolescent
subjects who are at least 12 years old

– a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to
Baseline and subject meets Hanifin and Rajka criteria

– moderate to severe AD at the Baseline Visit

– history of inadequate response to previous topical corticosteroid and/or topical
calcineurin inhibitor treatments or a medical inability to receive these treatments

Exclusion Criteria:

– prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor

– concurrent treatment with systemic therapy for AD (biologic or non-biologic) or
topical and/or phototherapy treatments

Additional Information, Locations & Contacts

Sponsors & Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc.

AbbVie

Please refer to this study by its ClinicalTrials.gov identifier: NCT03706040

Location

Contacts

UAB Department of Dermatology /ID# 211561

Birmingham, Alabama 35233

United States

Cognitive Clinical Trials /ID# 208895

Scottsdale, Arizona 85258-4446

United States

Cosmetic Dermatology of Orange County /ID# 205801

Anaheim, California 92807-4780

United States

Center for Dermatology Clin Res /ID# 204950

Fremont, California 94538

United States

Integrative Skin Science and Research /ID# 212486

Sacramento, California 95815-4500

United States

Cosmetic Laser Dermatology /ID# 210560

San Diego, California 92121-2119

United States

Therapeutics Clinical Research /ID# 203422

San Diego, California 92123

United States

Baumann Cosmetic and Research Institute /ID# 211333

Miami, Florida 33137-3254

United States

MetroDerm ACC Research /ID# 205958

Atlanta, Georgia 30342-1418

United States

Skin Care Physicians of Georgia /ID# 213188

Macon, Georgia 31217

United States

University Dermatology and Vein Clinic, LLC /ID# 210702

Darien, Illinois 60561

United States

Dundee Dermatology /ID# 212505

West Dundee, Illinois 60118

United States

The Indiana Clinical Trials Center /ID# 211618

Plainfield, Indiana 46168

United States

DermAssociates /ID# 206189

Rockville, Maryland 20850

United States

Great Lakes Research Group,Inc /ID# 206447

Bay City, Michigan 48706

United States

Grekin Skin Institute /ID# 210485

Warren, Michigan 48088

United States

Skin Cancer and Dermatology Institute (SCDI) /ID# 213041

Reno, Nevada 89052

United States

Psoriasis Treatment Ctr NJ /ID# 203203

East Windsor, New Jersey 08520

United States

Icahn School of Med Mt. Sinai /ID# 203650

New York, New York 10029

United States

Oregon Derm & Res. Ctr /ID# 202880

Portland, Oregon 97210

United States

Dermatologic SurgiCenter /ID# 208972

Drexel Hill, Pennsylvania 19026-1101

United States

Dermdox Center for Dermatology /ID# 212259

Hazleton, Pennsylvania 18201

United States

University of Pittsburgh MC /ID# 203296

Pittsburgh, Pennsylvania 15260

United States

Derm Assoc of Plymouth Meeting /ID# 208925

Plymouth Meeting, Pennsylvania 19462

United States

RI SkinDoc /ID# 203417

Johnston, Rhode Island 02910-4423

United States

Health Concepts /ID# 203205

Rapid City, South Dakota 57702

United States

Rivergate Dermatology & Skin Care Center /ID# 203372

Goodlettsville, Tennessee 37072-2301

United States

Tekton Research, Inc. /ID# 211558

Austin, Texas 78745

United States

Center for Clinical Studies - Houston (Binz) /ID# 203383

Houston, Texas 77004-8097

United States

Acclaim Dermatology /ID# 213026

Sugar Land, Texas 77479-2645

United States

Virginia Dermatology Research, PLLC /ID# 210154

Norfolk, Virginia 23502-2233

United States

Dominion Medical Associates /ID# 212986

Richmond, Virginia 23219

United States

The Vancouver Clinic, INC. PS /ID# 202930

Vancouver, Washington 98664

United States

Woden Dermatology /ID# 204778

Phillip, Australian Capital Territory 2606

Australia

St George Hospital /ID# 204780

Kogarah, New South Wales 2217

Australia

Veracity Clinical Research /ID# 204786

Woolloongabba, Queensland 4102

Australia

North Eastern Health Specialis /ID# 204785

Hectorville, South Australia 5073

Australia

Skin and Cancer Foundation /ID# 204779

Carlton, Victoria 3053

Australia

Fremantle Dermatology /ID# 204784

Fremantle, Western Australia 6160

Australia

Kirk Barber Research, CA /ID# 201046

Calgary, Alberta T2G 1B1

Canada

The University of Alberta /ID# 213009

Calgary, Alberta T2W 4X9

Canada

Institute for Skin Advancement /ID# 213003

Calgary, Alberta T3A 2N1

Canada

University of Alberta - Division of Rheumatology /ID# 213008

Edmonton, Alberta T6G 2B7

Canada

Karma Clinical Trials /ID# 215439

St. John's, Newfoundland and Labrador A1A 4Y3

Canada

Dr. Wei Jing Loo Medicine Prof /ID# 208849

London, Ontario N6H 5L5

Canada

Lynderm Research Inc. /ID# 201050

Markham, Ontario L3P 1X2

Canada

Medicor Research Inc. /ID# 211274

Sudbury, Ontario P3A 1W8

Canada

CHU Sainte-Justine /ID# 215263

Montreal, Quebec H3T 1C5

Canada

Dre. Angelique Gagne-Henley /ID# 208189

St-Jerome, Quebec J7Z 7E2

Canada

Chukyo Hospital /ID# 213667

Nagoya-shi, Aichi 457-8510

Japan

Kurume University Hospital /ID# 203139

Kurume-shi, Fukuoka 830-0011

Japan

Nippon Medical School Musashi Kosugi Hospital /ID# 213961

Kawasaki-shi, Kanagawa 211-8533

Japan

Nagaoka Red Cross Hospital /ID# 214140

Nagaoka-shi, Niigata 940-2108

Japan

University of the Ryukyus Hospital /ID# 203974

Nakagami-gun, Okinawa 903-0215

Japan

Osaka City University Hospital /ID# 203410

Osaka-shi, Osaka 545-0051

Japan

Hamamatsu University Hospital /ID# 203270

Higashi-ku, Shizuoka 431-3192

Japan

Tokyo Teishin Hospital /ID# 204101

Chiyoda-ku, Tokyo 102-8798

Japan

Teikyo University Hospital /ID# 202884

Itabashi-ku, Tokyo 173-8605

Japan

Tokyo Medical University Hospital /ID# 203647

Shinjuku-ku, Tokyo 160-0023

Japan

Dr. Samuel Sanchez, PSC /ID# 213117

Caguas, 00727

Puerto Rico

Cruz-Santana, Carolina, PR /ID# 213229

Carolina, 00985

Puerto Rico

Clinical Research Puerto Rico /ID# 213118

San Juan, 0090

Puerto Rico