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

• ClinicalTrials.gov Identifier: NCT03047395
• Recruitment Status: Active, not recruiting
• First Posted: February 9, 2017
• Last Update Posted: September 14, 2022
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: February 7, 2017
• First Posted Date: February 9, 2017
• Last Update Posted Date: September 14, 2022
• Actual Study Start Date: February 27, 2017
• Estimated Primary Completion Date: November 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 23, 2020)

Number of Participants With Adverse Events [ Time Frame: From first dose of study drug until 20 weeks after last dose of study drug (up to 272 weeks) ]

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.

Original Primary Outcome Measures (submitted: February 7, 2017)

• Percentage of Participants Achieving At Least 90% Reduction in Psoriasis Area and Severity Index (PASI) Score From Baseline (PASI 90) [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172) ]
  The PASI score is an established measure of clinical efficacy for psoriasis medications.
• Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172) ]
  The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
• Percentage of Participants Achieving At Least 75% Reduction in PASI Score From Baseline (PASI 75) [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172) ]
  The PASI score is an established measure of clinical efficacy for psoriasis medications.
• Percentage of Participants Achieving At Least 100% Reduction in PASI Score From Baseline (PASI 100) [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172) ]
  The PASI score is an established measure of clinical efficacy for psoriasis medications.
• Percentage of Participants Achieving an sPGA Score of Clear [ Time Frame: Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172) ]
  The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

Current Secondary Outcome Measures (submitted: October 25, 2019)

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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )
• Official Title: A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Psoriasis

Intervention

Biological: risankizumab

Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.

Other Names:

• ABBV-066 BI 655066
• Skyrizi

Study Arms

Experimental: Risankizumab

Participants will receive risankizumab administered by subcutaneous injection.

Intervention: Biological: risankizumab

• Publications *: Papp KA, Lebwohl MG, Puig L, Ohtsuki M, Beissert S, Zeng J, Rubant S, Sinvhal R, Zhao Y, Soliman AM, Alperovich G, Leonardi C. 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. Br J Dermatol. 2021 Dec;185(6):1135-1145. doi: 10.1111/bjd.20595. Epub 2021 Sep 21.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 9, 2022): 2200
• Original Estimated Enrollment (submitted: February 7, 2017): 1900
• Estimated Study Completion Date: November 30, 2023
• Estimated Primary Completion Date: November 30, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, Canada, Czechia, Finland, France, Germany, Japan, Korea, Republic of, Mexico, Poland, Portugal, Spain, Sweden, Taiwan, United States

Administrative Information

• NCT Number: NCT03047395
• Other Study ID Numbers: M15-997; 2016-003046-87 ( EudraCT Number ); 1311.31 ( Other Grant/Funding Number: AbbVie )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: Analytic Code
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• URL: https://vivli.org/ourmember/abbvie/

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: September 2022