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 |
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.
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.
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
725 West Granada Boulevard
Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
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2100 16th Avenue South
Birmingham, Alabama 35205
Birmingham, Alabama 35205
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1364 Ashley River Road
Charleston, South Carolina 29407
Charleston, South Carolina 29407
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710 Military Cutoff Road
Wilmington, North Carolina 28405
Wilmington, North Carolina 28405
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