Phase 3
Completed N=2,170
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )
Source: ClinicalTrials.gov NCT03047395 ↗Enrolled (actual)
2,170
Serious AEs
20.1%
Results posted
Dec 2024
Primary outcomePrimary: Number of Participants With Serious Adverse Events and Non-Serious Adverse Events — 435; 1215 Participants
◆ Published Evidence
Established
49citations · ~10 / year
Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up.
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.
Linked Publications (4)
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Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up.
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Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis.
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Long-Term Safety and Efficacy of Risankizumab to Treat Moderate-to-Severe Plaque Psoriasis: Final LIMMitless Phase 3, Open-Label Extension Trial Results.
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A Descriptive, Post Hoc Analysis of Efficacy and Safety of Risankizumab in Diverse Racial and Ethnic Patient Populations With Moderate-to-Severe Psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events and Non-Serious Adverse Events |
435; 1215 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03047395) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.