A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:9/26/2018
Start Date:February 27, 2017
End Date:December 28, 2021

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A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)

The purpose of this study is to investigate the long-term safety and efficacy of risankizumab
in the treatment of moderate to severe chronic plaque psoriasis.

This is a Phase 3, single-arm, multicenter OLE study designed to investigate the long-term
safety and efficacy of 150 mg risankizumab in the treatment of moderate to severe chronic
plaque psoriasis. Approximately 2200 subjects who meet the entry criteria are planned to be
enrolled in this study, rolling over from the preceding Phase 2/3 studies.

Inclusion Criteria:

- Subjects with a history of moderate to severe chronic plaque psoriasis, who have
completed one of the preceding studies.

- Subjects must be candidates for prolonged open label risankizumab treatment according
to investigator judgment.

- Females of childbearing potential must have a negative urine pregnancy test result at
Baseline.

If female, subject must be either postmenopausal, OR permanently surgically sterile OR for
women of childbearing potential practicing at least one protocol specified method of birth
control, starting at Baseline through at least 20 weeks after the last dose of study drug.

- Subjects must have signed and dated a written informed consent in accordance with Good
Clinical Practice (GCP) and local legislation prior to admission into the study.

Exclusion Criteria:

- Premature discontinuation for any reason in the preceding study.

- Subjects who have developed guttate, erythrodermic, pustular or drug-induced psoriasis
as diagnosed by the investigator during the preceding study.

- Use of any prohibited medication or any drug considered likely to interfere with the
safe conduct of the study, as assessed by the investigator.

- Known tuberculosis (TB) or evidence of TB infection. Subjects with a positive
QuantiFERON® TB test or a positive purified protein derivate (PPD) skin test result
may participate in the study if further work up (according to local
practice/guidelines) establishes conclusively that the subject has no evidence of
active TB.

- Subjects who have developed active or suspected malignancy during the preceding study,
except appropriately treated basal cell or squamous cell carcinoma of the skin or in
situ carcinoma of uterine cervix.

- Subjects who have laboratory evidence of Human Immunodeficiency Virus (HIV), hepatitis
B or hepatitis C viral infection from laboratory testing within the preceding clinical
trial or any other source.

- Evidence of a current or previous disease, medical condition (including chronic
alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ
transplant), medical examination finding (including vital signs and ECG), or
laboratory value outside the reference range that in the opinion of the investigator
is clinically significant and would make the study participant unreliable to adhere to
the protocol or to complete the study, compromise the safety of the subject, or
compromise the quality of the data.

- History of allergy/hypersensitivity to a systemically administered biologic agent or
its excipients.

- Previous enrollment in this study.

- Female subject who is pregnant, breastfeeding or is considering becoming pregnant
during the study or within 20 weeks after the last dose of study drug.

- Time elapsed is > 8 weeks since the completion visit in the preceding study.

- Subject is considered by the investigator for any reason, to be an unsuitable
candidate for the study and not able to comply with the study protocol.
We found this trial at
79
sites
10600 South Quivira Road
Overland Park, Kansas 66215
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Alpharetta, Georgia 30022
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Ann Arbor, MI
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Atlanta, GA
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3705 Medical Parkway
Austin, Texas 78705
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Bakersfield, California 93309
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200 S Wenona St # 170
Bay City, Michigan 48706
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Bellaire, TX
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8920 Wilshire Boulevard
Beverly Hills, California 90211
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Beverly Hills, CA
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2100 16th Avenue South
Birmingham, Alabama 35205
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Birmingham, Alabama 35233
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Boston, Massachusetts 02114
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Boston, MA
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Bridgeport, Connecticut 06606
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Bridgeport, CT
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1364 Ashley River Road
Charleston, South Carolina 29407
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Charleston, SC
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Charlotte, North Carolina 28210
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Charlotte, NC
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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1653 West Congress Parkway
Chicago, Illinois 60612
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Cincinnati, OH
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Clinton Township, Michigan 48038
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Coral Gables, Florida 33134
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Dallas, TX
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Duncansville, Pennsylvania 16635
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East Windsor, New Jersey 08520
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Encinitas, California 92024
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Encino, California 91436
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Evanston, Illinois 60201
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Farmington, Connecticut 06030
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103-11 68th Drive
Forest Hills, New York 11375
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Fremont, CA
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Fridley, MN
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Greer, South Carolina 29650
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High Point, North Carolina 27262
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High Point, NC
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Houston, TX
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1900 Saint James Place
Houston, Texas 77056
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Indianapolis, Indiana 46168
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Indianapolis, IN
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8103 Clearvista Parkway
Indianapolis, Indiana 46256
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1524 Atwood Avenue
Johnston, Rhode Island 02919
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Lebanon, New Hampshire 03756
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Los Angeles, California 90027
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Los Angeles, California 90045
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485 East Gray Street
Louisville, Kentucky 40217
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3810 Springhurst Boulevard
Louisville, Kentucky 40241
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Methuen, Massachusetts 01844
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Mount Pleasant, South Carolina 29464
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New Albany, IN
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New York, New York 10065
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6160 Kempsville Circle
Norfolk, Virginia 23502
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Oceanside, California 92056
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Omaha, Nebraska 68144
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725 West Granada Boulevard
Ormond Beach, Florida 32174
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Pasadena, California 91105
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Philadelphia, Pennsylvania 19103
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Pittsburgh, Pennsylvania 15260
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5111 South Ridgewood Avenue
Port Orange, Florida 32127
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Portland, Oregon 97210
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Raleigh, North Carolina 27612
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5410 Sheridan Lake Road
Rapid City, South Dakota 57702
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Rogers, AR
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5301 Keystone Court
Rolling Meadows, Illinois 60008
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1034 South Brentwood Boulevard
Saint Louis, Missouri 63117
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16110 Via Shavano
San Antonio, Texas 78249
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501 Washington Street
San Diego, California 92103
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Santa Ana, California 92701
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Seattle, Washington 98101
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Sherman Oaks, California 91403
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South Bend, Indiana 46617
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Spokane, Washington 99202
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Stony Brook, New York 11790
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Troy, Michigan 48084
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Verona, New Jersey 07044
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Webster, TX
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West Dundee, Illinois 60118
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Williamsville, New York 14221
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710 Military Cutoff Road
Wilmington, North Carolina 28405
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