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

AbbVie

Status and phase

Completed

Phase 3

Conditions

Psoriasis

Treatments

Biological: risankizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03047395

M15-997

1311.31 (Other Grant/Funding Number)

2016-003046-87 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.