The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03047395




Registration number
NCT03047395
Ethics application status
Date submitted
7/02/2017
Date registered
9/02/2017
Date last updated
23/05/2019

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
Other interventions - risankizumab

Experimental: Risankizumab - Participants will receive risankizumab administered by subcutaneous injection.


Other interventions: risankizumab
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving an sPGA Score of Clear - The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Timepoint [1] 0 0
Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172)
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172)
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172)
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172)
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and End of Observation visit (up to week 172)

Eligibility
Key inclusion criteria
- Subjects with a history of moderate to severe chronic plaque psoriasis, who have
completed one of the preceding studies.

- Subjects 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, subject 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.

- Subjects 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Premature discontinuation for any reason in the preceding study.

- Subjects 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.

- Known tuberculosis (TB) or evidence of TB infection. Subjects with a positive
QuantiFERON® TB test or a positive purified protein derivate (PPD) skin test result
may participate in the study if further work up (according to local
practice/guidelines) establishes conclusively that the subject has no evidence of
active TB.

- Subjects who have developed active or suspected malignancy during the preceding study,
except appropriately treated basal cell or squamous cell carcinoma of the skin or in
situ carcinoma of uterine cervix.

- Subjects who have laboratory evidence of Human Immunodeficiency Virus (HIV), hepatitis
B or hepatitis C viral infection from laboratory testing within the preceding clinical
trial or any other source.

- 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.

- History of allergy/hypersensitivity to a systemically administered biologic agent or
its excipients.

- 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.

- Subject 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
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Woden Dermatology /ID# 154307 - Phillip
Recruitment hospital [2] 0 0
St George Hospital /ID# 154308 - Kogarah
Recruitment hospital [3] 0 0
Specialist Connect Pty Ltd /ID# 154311 - Woolloongabba
Recruitment hospital [4] 0 0
North Eastern Health Specialis /ID# 154309 - Hectorville
Recruitment hospital [5] 0 0
Skin and Cancer Foundation /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
5073 - Hectorville
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Rhode Island
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
South Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
Austria
State/province [29] 0 0
Wien
Country [30] 0 0
Austria
State/province [30] 0 0
Feldkirch
Country [31] 0 0
Belgium
State/province [31] 0 0
Bruxelles-Capitale
Country [32] 0 0
Belgium
State/province [32] 0 0
Oost-Vlaanderen
Country [33] 0 0
Belgium
State/province [33] 0 0
Liege
Country [34] 0 0
Belgium
State/province [34] 0 0
Loverval
Country [35] 0 0
Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
British Columbia
Country [37] 0 0
Canada
State/province [37] 0 0
Newfoundland and Labrador
Country [38] 0 0
Canada
State/province [38] 0 0
Nova Scotia
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
Czechia
State/province [41] 0 0
Brno
Country [42] 0 0
Czechia
State/province [42] 0 0
Nachod
Country [43] 0 0
Czechia
State/province [43] 0 0
Orlova - Lutyne
Country [44] 0 0
Czechia
State/province [44] 0 0
Prague 1
Country [45] 0 0
Czechia
State/province [45] 0 0
Prague
Country [46] 0 0
Finland
State/province [46] 0 0
Tampere
Country [47] 0 0
Finland
State/province [47] 0 0
Turku
Country [48] 0 0
France
State/province [48] 0 0
Seine-Maritime
Country [49] 0 0
France
State/province [49] 0 0
Nice
Country [50] 0 0
France
State/province [50] 0 0
Toulouse
Country [51] 0 0
Germany
State/province [51] 0 0
Baden-Wuerttemberg
Country [52] 0 0
Germany
State/province [52] 0 0
Bayern
Country [53] 0 0
Germany
State/province [53] 0 0
Hessen
Country [54] 0 0
Germany
State/province [54] 0 0
Niedersachsen
Country [55] 0 0
Germany
State/province [55] 0 0
Rheinland-Pfalz
Country [56] 0 0
Germany
State/province [56] 0 0
Sachsen
Country [57] 0 0
Germany
State/province [57] 0 0
Schleswig-Holstein
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin
Country [59] 0 0
Germany
State/province [59] 0 0
Bochum
Country [60] 0 0
Germany
State/province [60] 0 0
Bonn
Country [61] 0 0
Germany
State/province [61] 0 0
Darmstadt
Country [62] 0 0
Germany
State/province [62] 0 0
Dresden
Country [63] 0 0
Germany
State/province [63] 0 0
Göttingen
Country [64] 0 0
Germany
State/province [64] 0 0
Hamburg
Country [65] 0 0
Germany
State/province [65] 0 0
Mahlow
Country [66] 0 0
Germany
State/province [66] 0 0
Mainz
Country [67] 0 0
Germany
State/province [67] 0 0
Munich
Country [68] 0 0
Germany
State/province [68] 0 0
Schwerin
Country [69] 0 0
Germany
State/province [69] 0 0
Tuebingen
Country [70] 0 0
Germany
State/province [70] 0 0
Witten
Country [71] 0 0
Germany
State/province [71] 0 0
Wuppertal
Country [72] 0 0
Japan
State/province [72] 0 0
Aichi
Country [73] 0 0
Japan
State/province [73] 0 0
Fukuoka
Country [74] 0 0
Japan
State/province [74] 0 0
Gifu
Country [75] 0 0
Japan
State/province [75] 0 0
Hokkaido
Country [76] 0 0
Japan
State/province [76] 0 0
Hyogo
Country [77] 0 0
Japan
State/province [77] 0 0
Iwate
Country [78] 0 0
Japan
State/province [78] 0 0
Kagawa
Country [79] 0 0
Japan
State/province [79] 0 0
Kanagawa
Country [80] 0 0
Japan
State/province [80] 0 0
Kyoto
Country [81] 0 0
Japan
State/province [81] 0 0
Mie
Country [82] 0 0
Japan
State/province [82] 0 0
Miyagi
Country [83] 0 0
Japan
State/province [83] 0 0
Nagano
Country [84] 0 0
Japan
State/province [84] 0 0
Nagasaki
Country [85] 0 0
Japan
State/province [85] 0 0
Okayama
Country [86] 0 0
Japan
State/province [86] 0 0
Osaka
Country [87] 0 0
Japan
State/province [87] 0 0
Shizuoka
Country [88] 0 0
Japan
State/province [88] 0 0
Tochigi
Country [89] 0 0
Japan
State/province [89] 0 0
Tokyo
Country [90] 0 0
Japan
State/province [90] 0 0
Fukushima-shi
Country [91] 0 0
Japan
State/province [91] 0 0
Sakyo-ku
Country [92] 0 0
Japan
State/province [92] 0 0
Sapporo
Country [93] 0 0
Japan
State/province [93] 0 0
UBE
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Busan Gwang Yeogsi
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Incheon Gwang Yeogsi
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Jeonranamdo
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Seoul Teugbyeolsi
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Seoul
Country [99] 0 0
Mexico
State/province [99] 0 0
Aguascalientes
Country [100] 0 0
Mexico
State/province [100] 0 0
Monterrey
Country [101] 0 0
Poland
State/province [101] 0 0
Dolnoslaskie
Country [102] 0 0
Poland
State/province [102] 0 0
Malopolskie
Country [103] 0 0
Poland
State/province [103] 0 0
Mazowieckie
Country [104] 0 0
Poland
State/province [104] 0 0
Podlaskie
Country [105] 0 0
Poland
State/province [105] 0 0
Pomorskie
Country [106] 0 0
Poland
State/province [106] 0 0
Lodz
Country [107] 0 0
Poland
State/province [107] 0 0
Lublin
Country [108] 0 0
Poland
State/province [108] 0 0
Poznan
Country [109] 0 0
Portugal
State/province [109] 0 0
Braga
Country [110] 0 0
Portugal
State/province [110] 0 0
Lisboa
Country [111] 0 0
Portugal
State/province [111] 0 0
Porto
Country [112] 0 0
Spain
State/province [112] 0 0
Barcelona
Country [113] 0 0
Spain
State/province [113] 0 0
Madrid
Country [114] 0 0
Spain
State/province [114] 0 0
Valencia
Country [115] 0 0
Sweden
State/province [115] 0 0
Goteborg
Country [116] 0 0
Sweden
State/province [116] 0 0
Solna
Country [117] 0 0
Sweden
State/province [117] 0 0
Stockholm
Country [118] 0 0
Taiwan
State/province [118] 0 0
Tainan
Country [119] 0 0
Taiwan
State/province [119] 0 0
Taipei
Country [120] 0 0
Taiwan
State/province [120] 0 0
New Taipei City

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03047395
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

Summary results
Other publications