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

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Biological: risankizumab

• Registration Number: NCT03047395
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

This is a Phase 3, single-arm, multicenter open label extension (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 participants who meet the entry criteria are planned to be enrolled in this study, rolling over from the preceding Phase 2/3 studies.

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-02-27
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Status Verified: 2024-11
• Results First Submitted: 2024-11-19
• Results First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Results First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2170

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Risankizumab	risankizumab	Participants will receive risankizumab administered by subcutaneous injection.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events	Median follow-up time of 1905 days	An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.

Trial Locations

Locations (233)

Total Skin and Beauty Dermatology Center /ID# 154000; 🇺🇸 Birmingham, Alabama, United States

Great Lakes Research Group - Bay City /ID# 153998; 🇺🇸 Bay City, Michigan, United States

Oregon Medical Research Center /ID# 154003; 🇺🇸 Portland, Oregon, United States

Center for Clinical Studies Webster TX /ID# 154150; 🇺🇸 Webster, Texas, United States

Sinclair Dermatology - Melbourne /ID# 154310; 🇦🇺 Melbourne, Victoria, Australia

Universitair Ziekenhuis Brussel /ID# 154295; 🇧🇪 Jette, Bruxelles-Capitale, Belgium

Cliniques Universitaires UCL Saint-Luc /ID# 154294; 🇧🇪 Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium

SKiN Centre for Dermatology /ID# 153853; 🇨🇦 Peterborough, Ontario, Canada

Clintrial s.r.o. /ID# 153889; 🇨🇿 Prague 10, Czechia

Pratia Prague s.r.o. /ID# 153897; 🇨🇿 Prague, Czechia

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