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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03047395
Registration number
NCT03047395
Ethics application status
Date submitted
7/02/2017
Date registered
9/02/2017
Titles & IDs
Public title
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )
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Scientific title
A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)
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Secondary ID [1]
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0
2016-003046-87
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Secondary ID [2]
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M15-997
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Universal Trial Number (UTN)
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Trial acronym
LIMMITLESS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
0
0
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Condition category
Condition code
Skin
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0
0
0
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Dermatological conditions
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Skin
0
0
0
0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - risankizumab
Experimental: Risankizumab - Participants will receive risankizumab administered by subcutaneous injection.
Treatment: Other: risankizumab
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.
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Intervention code [1]
0
0
Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose of study drug until 20 weeks after last dose of study drug (up to 272 weeks)
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Secondary outcome [1]
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Percentage of Participants Achieving an Static Physician Global Assessment (sPGA) Score of Clear
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Assessment method [1]
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0
The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
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Timepoint [1]
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Up to Week 252
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Secondary outcome [2]
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Percentage of Participants Achieving At Least 100% Reduction in PASI Score From Baseline (PASI 100)
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Assessment method [2]
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The PASI score is an established measure of clinical efficacy for psoriasis medications.
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Timepoint [2]
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Up to Week 252
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Secondary outcome [3]
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Percentage of Participants Achieving At Least 75% Reduction in PASI Score From Baseline (PASI 75)
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Assessment method [3]
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The PASI score is an established measure of clinical efficacy for psoriasis medications.
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Timepoint [3]
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Up to Week 252
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Secondary outcome [4]
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Percentage of Participants Achieving At Least 90% Reduction in Psoriasis Area and Severity Index (PASI) Score From Baseline (PASI 90)
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Assessment method [4]
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0
The PASI score is an established measure of clinical efficacy for psoriasis medications.
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Timepoint [4]
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Up to Week 252
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Secondary outcome [5]
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Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear
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Assessment method [5]
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0
The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
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Timepoint [5]
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Up to Week 252
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/02/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/11/2023
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Sample size
Target
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Accrual to date
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Final
2172
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Paratus Clinical Research Woden /ID# 154307 - Phillip
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Recruitment hospital [2]
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St George Dermatology & Skin Cancer Centre /ID# 154308 - Kogarah
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Specialist Connect Pty Ltd /ID# 154311 - Woolloongabba
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North Eastern Health Specialists /ID# 154309 - Campbelltown
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Skin Health Institute Inc /ID# 154305 - Carlton
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Sinclair Dermatology /ID# 154310 - East Melbourne
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Fremantle Dermatology /ID# 154306 - Fremantle
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2606 - Phillip
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2217 - Kogarah
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4102 - Woolloongabba
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5074 - Campbelltown
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3053 - Carlton
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3002 - East Melbourne
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6160 - Fremantle
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03047395
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
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/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03047395