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

Completed · Phase 3

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT03047395

Run by

AbbVie

People needed

2170

Starts

2017-02-27

Expected to finish

2023-11-29

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with a history of moderate to severe chronic plaque psoriasis, who have completed one of the preceding studies.
• Participants 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, participant 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.
• Participants 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.

You may not qualify if…

• Premature discontinuation for any reason in the preceding study.
• Participants 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.
• 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.
• 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.
• Participant 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.

Where it is running

• University of Alabama at Birmingham - Main /ID# 153983 — Birmingham, Alabama, United States
• NW Arkansas Clinical Trials Center /ID# 154014 — Rogers, Arkansas, United States
• Bakersfield Derma & Skin Cance /ID# 154008 — Bakersfield, California, United States
• California Dermatology and Research Institute /ID# 154007 — Encinitas, California, United States
• T. Joseph Raoof, MD, Inc. /ID# 154078 — Encino, California, United States
• Center for Dermatology Clinical Research /ID# 154009 — Fremont, California, United States
• Kaiser Permanente Los Angeles /ID# 154079 — Los Angeles, California, United States
• Dermatology Research Associates /ID# 153977 — Los Angeles, California, United States
• Wallace Medical Group /ID# 154025 — Los Angeles, California, United States
• Dermatology Specialists, Inc /ID# 153984 — Oceanside, California, United States
• Huntington Medical Foundation /ID# 154002 — Pasadena, California, United States
• Medderm Associates /ID# 154098 — San Diego, California, United States
• Southern California Dermatology /ID# 154006 — Santa Ana, California, United States
• UNISON Center for Clinical Tri /ID# 153979 — Sherman Oaks, California, United States
• New England Research Associates, LLC /ID# 154004 — Bridgeport, Connecticut, United States
• UConn Health /ID# 154128 — Farmington, Connecticut, United States
• Florida Academic Centers Research /ID# 154045 — Coral Gables, Florida, United States
• Leavitt Medical Associates of Florida /ID# 154046 — Ormond Beach, Florida, United States
• Progressive Medical Research /ID# 154027 — Port Orange, Florida, United States
• Hamilton Research, LLC /ID# 153980 — Alpharetta, Georgia, United States
• Advanced Medical Research, PC /ID# 153999 — Sandy Springs, Georgia, United States
• Northwestern University Feinberg School of Medicine /ID# 153974 — Chicago, Illinois, United States
• Rush University Medical Center /ID# 154099 — Chicago, Illinois, United States
• Arlington Dermatology /ID# 153975 — Rolling Meadows, Illinois, United States
• Total Skin and Beauty Dermatology Center /ID# 154000 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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