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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)

Conditions
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Psoriasis

Intervention / Treatment
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* Biological: risankizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risankizumab<br>Participants will receive risankizumab administered by subcutaneous injection. | Biological: risankizumab<br>* Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.<br>* Other names: Skyrizi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | An adverse event (AE) 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 (SAE) 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. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | From first dose of study drug until 20 weeks after last dose of study drug (up to 272 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving an Static Physician Global Assessment (sPGA) Score of Clear | The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. | Up to Week 252 | 
| Percentage of Participants Achieving At Least 100% Reduction in PASI Score From Baseline (PASI 100) | The PASI score is an established measure of clinical efficacy for psoriasis medications. | Up to Week 252 | 
| Percentage of Participants Achieving At Least 75% Reduction in PASI Score From Baseline (PASI 75) | The PASI score is an established measure of clinical efficacy for psoriasis medications. | Up to Week 252 | 
| Percentage of Participants Achieving At Least 90% Reduction in Psoriasis Area and Severity Index (PASI) Score From Baseline (PASI 90) | The PASI score is an established measure of clinical efficacy for psoriasis medications. | Up to Week 252 | 
| Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear | The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. | Up to Week 252 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-066, BI 655066