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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 )
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)
Secondary ID [1] 0 0
2016-003046-87
Secondary ID [2] 0 0
M15-997
Universal Trial Number (UTN)
Trial acronym
LIMMITLESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
From first dose of study drug until 20 weeks after last dose of study drug (up to 272 weeks)
Secondary outcome [1] 0 0
Percentage of Participants Achieving an Static Physician Global Assessment (sPGA) Score of Clear
Timepoint [1] 0 0
Up to Week 252
Secondary outcome [2] 0 0
Percentage of Participants Achieving At Least 100% Reduction in PASI Score From Baseline (PASI 100)
Timepoint [2] 0 0
Up to Week 252
Secondary outcome [3] 0 0
Percentage of Participants Achieving At Least 75% Reduction in PASI Score From Baseline (PASI 75)
Timepoint [3] 0 0
Up to Week 252
Secondary outcome [4] 0 0
Percentage of Participants Achieving At Least 90% Reduction in Psoriasis Area and Severity Index (PASI) Score From Baseline (PASI 90)
Timepoint [4] 0 0
Up to Week 252
Secondary outcome [5] 0 0
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear
Timepoint [5] 0 0
Up to Week 252

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/11/2023
Sample size
Target
Accrual to date
Final
2172
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research Woden /ID# 154307 - Phillip
Recruitment hospital [2] 0 0
St George Dermatology & Skin Cancer Centre /ID# 154308 - Kogarah
Recruitment hospital [3] 0 0
Specialist Connect Pty Ltd /ID# 154311 - Woolloongabba
Recruitment hospital [4] 0 0
North Eastern Health Specialists /ID# 154309 - Campbelltown
Recruitment hospital [5] 0 0
Skin Health Institute Inc /ID# 154305 - Carlton
Recruitment hospital [6] 0 0
Sinclair Dermatology /ID# 154310 - East Melbourne
Recruitment hospital [7] 0 0
Fremantle Dermatology /ID# 154306 - Fremantle
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5074 - Campbelltown
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3002 - East Melbourne
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment outside Australia
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Tainan
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Taipei City
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Taiwan
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Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


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