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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03047395
Recruitment Status : Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Psoriasis Biological: risankizumab Phase 3

Detailed Description:
This is a Phase 3, single-arm, multicenter 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 subjects who meet the entry criteria are planned to be enrolled in this study, rolling over from the preceding Phase 2/3 studies.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2179 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : January 27, 2022
Estimated Study Completion Date : January 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Risankizumab
Participants will receive risankizumab administered by subcutaneous injection.
Biological: risankizumab
Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.
Other Name: ABBV-066 BI 655066




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047395


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Locations
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United States, Alabama
Total Skin and Beauty Derm Ctr /ID# 154000
Birmingham, Alabama, United States, 35205
University of Alabama /ID# 153983
Birmingham, Alabama, United States, 35233
United States, Arkansas
NW Arkansas Clin Trials Center /ID# 154014
Rogers, Arkansas, United States, 72714
United States, California
Bakersfield Derma & Skin Cance /ID# 154008
Bakersfield, California, United States, 93309
Wallace Medical Group, Inc. /ID# 154025
Beverly Hills, California, United States, 90211
CA Dermatology & Clinical Rese /ID# 154007
Encinitas, California, United States, 92024
T. Joseph Raoof, MD, Inc. /ID# 154078
Encino, California, United States, 91436
Center for Dermatology Clin Res /ID# 154009
Fremont, California, United States, 94538
Kaiser Permanente Los Angeles /ID# 154079
Los Angeles, California, United States, 90027
Dermatology Res. Assoc., CA /ID# 153977
Los Angeles, California, United States, 90045
Dermatology Specialists, Inc /ID# 153984
Oceanside, California, United States, 92056
Huntington Medical Foundation /ID# 154002
Pasadena, California, United States, 91105
Medderm Associates /ID# 154098
San Diego, California, United States, 92103
Southern California Derma. Inc /ID# 154006
Santa Ana, California, United States, 92701
UNISON Center for Clinical Tri /ID# 153979
Sherman Oaks, California, United States, 91403
United States, Connecticut
New England Research Associates, LLC /ID# 154004
Bridgeport, Connecticut, United States, 06606-1827
UConn Health /ID# 154128
Farmington, Connecticut, United States, 06030
United States, Florida
Florida Academic Centers Research /ID# 154045
Coral Gables, Florida, United States, 33134
Leavitt Medical Associates of Florida /ID# 154046
Ormond Beach, Florida, United States, 32174
Progressive Medical Research /ID# 154027
Port Orange, Florida, United States, 32127
United States, Georgia
ATL Derma, Vein & Res Ctr /ID# 153980
Alpharetta, Georgia, United States, 30022
Europaeisches Brusstzentrum /ID# 153999
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern University Feinberg School of Medicine /ID# 153974
Chicago, Illinois, United States, 60611-2927
Rush University Medical Center /ID# 154099
Chicago, Illinois, United States, 60612
Arlington Dermatology /ID# 153975
Rolling Meadows, Illinois, United States, 60008-3811
NorthShore University HealthSystem - Skokie /ID# 154011
Skokie, Illinois, United States, 60077
Dundee Dermatology /ID# 154110
West Dundee, Illinois, United States, 60118
United States, Indiana
Dawes Fretzin, LLC /ID# 154146
Indianapolis, Indiana, United States, 46256
The Dermatology Center PSC - New Albany /ID# 154075
New Albany, Indiana, United States, 47150
The Indiana Clinical Trials Center /ID# 153976
Plainfield, Indiana, United States, 46168
The South Bend Clinic Center /ID# 154147
South Bend, Indiana, United States, 46617
United States, Kansas
Kansas City Dermatology PA /ID# 153993
Overland Park, Kansas, United States, 66215
United States, Kentucky
Skin Sciences, PLLC /ID# 153991
Louisville, Kentucky, United States, 40217
DS Research /ID# 154028
Louisville, Kentucky, United States, 40241
United States, Massachusetts
Massachusetts General Hospital /ID# 153990
Boston, Massachusetts, United States, 02114
ActivMed Practices and Researc /ID# 154044
Methuen, Massachusetts, United States, 01844
United States, Michigan
University of Michigan Hospitals /ID# 154111
Ann Arbor, Michigan, United States, 48109
Great Lakes Research Group,Inc /ID# 153998
Bay City, Michigan, United States, 48706
Michigan Center for Skin Care /ID# 153986
Clinton Township, Michigan, United States, 48038
Somerset Skin Centre /ID# 154097
Troy, Michigan, United States, 48084
United States, Minnesota
Minnesota Clinical Study Center /ID# 154015
Fridley, Minnesota, United States, 55432-3134
United States, Missouri
Central Dermatology, PC /ID# 154013
Saint Louis, Missouri, United States, 63117
United States, Nebraska
Skin Specialists, PC /ID# 154024
Omaha, Nebraska, United States, 68144
United States, New Hampshire
Dartmouth-Hitchcock Med Ctr /ID# 154095
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Psoriasis Treatment Ctr NJ /ID# 154001
East Windsor, New Jersey, United States, 08520
The Dermatology Group, PC /ID# 202489
Verona, New Jersey, United States, 07044
United States, New York
Forest Hills Dermatology Group /ID# 154113
Forest Hills, New York, United States, 11375
Icahn School of Med Mt. Sinai /ID# 154129
New York, New York, United States, 10029
The Rockefeller University /ID# 153994
New York, New York, United States, 10065
DermResearchCenter of NY, Inc. /ID# 154012
Stony Brook, New York, United States, 11790
Buffalo Medical Group /ID# 154148
Williamsville, New York, United States, 14221
United States, North Carolina
Darst Dermatology /ID# 154076
Charlotte, North Carolina, United States, 28277
Dermatology Consulting Service /ID# 154010
High Point, North Carolina, United States, 27262
Wake Research Associates, LLC /ID# 202490
Raleigh, North Carolina, United States, 27612
Wilmington Dermatology Center /ID# 154109
Wilmington, North Carolina, United States, 28403
United States, Ohio
Synexus Research Cincinnati /ID# 153997
Cincinnati, Ohio, United States, 45236
United States, Oregon
Oregon Derm & Res. Ctr /ID# 153982
Portland, Oregon, United States, 97210
Oregon Medical Res Center PC /ID# 154003
Portland, Oregon, United States, 97223
United States, Pennsylvania
Altoona Ctr Clinical Res /ID# 153981
Duncansville, Pennsylvania, United States, 16635
Paddington Testing Co., Inc. /ID# 154022
Philadelphia, Pennsylvania, United States, 19103
University of Pittsburgh MC /ID# 153995
Pittsburgh, Pennsylvania, United States, 15260
United States, Rhode Island
Clinical Partners, LLC /ID# 154096
Johnston, Rhode Island, United States, 02919
United States, South Carolina
Derm & Laser Ctr of Charleston /ID# 154112
Charleston, South Carolina, United States, 29414
Radiant Research - Salt Lake City /ID# 154127
Greer, South Carolina, United States, 29650
Coastal Carolina Research Ctr /ID# 153992
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
Health Concepts /ID# 153996
Rapid City, South Dakota, United States, 57702
United States, Texas
Austin Dermatology Associates /ID# 154042
Austin, Texas, United States, 78705
Bellaire Dermatology Associate /ID# 153987
Bellaire, Texas, United States, 77401
Modern Research Associates, PL /ID# 154043
Dallas, Texas, United States, 75231
Menter Dermatology Res Inst /ID# 153985
Dallas, Texas, United States, 75246
Center for Clinical Studies /ID# 154005
Houston, Texas, United States, 77044
Suzanne Bruce and Associates /ID# 154026
Houston, Texas, United States, 77056
Derm Clin Res Ctr San Antonio /ID# 153978
San Antonio, Texas, United States, 78229
Progressive Clinical Research /ID# 154149
San Antonio, Texas, United States, 78229
Stephen Miller, MD PA /ID# 154077
San Antonio, Texas, United States, 78249
Center for Clinical Studies - Webster TX /ID# 154150
Webster, Texas, United States, 77598
United States, Virginia
Virginia Clinical Research /ID# 154016
Norfolk, Virginia, United States, 23507
United States, Washington
Dermatology Associates /ID# 153988
Seattle, Washington, United States, 98101
Premier Clinical Research /ID# 154284
Spokane, Washington, United States, 99202
Australia, Australian Capital Territory
Woden Dermatology /ID# 154307
Phillip, Australian Capital Territory, Australia, 2606
Australia, New South Wales
St George Hospital /ID# 154308
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Specialist Connect Pty Ltd /ID# 154311
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
North Eastern Health Specialis /ID# 154309
Hectorville, South Australia, Australia, 5073
Australia, Victoria
Skin and Cancer Foundation /ID# 154305
Carlton, Victoria, Australia, 3053
Sinclair Dermatology /ID# 154310
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Fremantle Dermatology /ID# 154306
Fremantle, Western Australia, Australia, 6160
Austria
Krankenanstalt Rudolfstiftung /ID# 154300
Vienna, Wien, Austria, 1030
Medizinische Universität Wien /ID# 154302
Vienna, Wien, Austria, 1090
Landeskrankenhaus Feldkirch /ID# 154303
Feldkirch, Austria, 6800
Belgium
CUB Hospital Erasme /ID# 154293
Brussels, Bruxelles-Capitale, Belgium, 1070
UZ Brussel /ID# 154295
Jette, Bruxelles-Capitale, Belgium, 1090
Cliniques Universitaires Saint Luc /ID# 154294
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
UZ Gent /ID# 154296
Gent, Oost-Vlaanderen, Belgium, 9000
Centre Hosp. Univ. de Liege /ID# 154297
Liege, Belgium, 4000
Grand Hopital de Charleroi /ID# 154298
Loverval, Belgium, 6280
Canada, Alberta
Kirk Barber Research, CA /ID# 153840
Calgary, Alberta, Canada, T2G 1B1
Institute for Skin Advancement /ID# 153850
Calgary, Alberta, Canada, T3A 2N1
Stratica Medical /ID# 153848
Edmonton, Alberta, Canada, T5K 2V4
Canada, British Columbia
Dr. Chih-ho Hong Medical Inc. /ID# 153842
Surrey, British Columbia, Canada, V3R 6A7
Enverus Medical Research /ID# 153851
Surrey, British Columbia, Canada, V3V 0C6
Canada, Newfoundland and Labrador
Karma Clinical Trials /ID# 153876
St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
Canada, Nova Scotia
Eastern Canada Cutaneous Resea /ID# 153870
Halifax, Nova Scotia, Canada, B3H 1Z2
Canada, Ontario
CCA Medical Research /ID# 153859
Ajax, Ontario, Canada, L1S 7K8
Kingsway Clinical Research /ID# 154292
Etobicoke, Ontario, Canada, M8X 1Y9
Dermatrials Research /ID# 153847
Hamilton, Ontario, Canada, L8N 1Y2
Guenther Derma Res Ctr, CA /ID# 153841
London, Ontario, Canada, N6A 3H7
Lynderm Research Inc. /ID# 153861
Markham, Ontario, Canada, L3P 1X2
DermEdge Research Inc. /ID# 153843
Mississauga, Ontario, Canada, L5H 1G9
North Bay Dermatology Centre /ID# 153845
North Bay, Ontario, Canada, P1B 3Z7
The Centre for Clinical Trials /ID# 153871
Oakville, Ontario, Canada, L6J 7W5
Dermatology Ottawa Research Centre /ID# 153862
Ottawa, Ontario, Canada, K2C 3N2
SKIN Centre for Dermatology /ID# 153853
Peterborough, Ontario, Canada, K9J 5K2
The Center For Dermatology /ID# 153844
Richmond Hill, Ontario, Canada, L4B 1A5
York Dermatology Center /ID# 153860
Richmond Hill, Ontario, Canada, L4C 9M7
Toronto Research Centre /ID# 153852
Toronto, Ontario, Canada, M3H 5Y8
Research Toronto /ID# 153854
Toronto, Ontario, Canada, M4W 2N2
K. Papp Clinical Research /ID# 153855
Waterloo, Ontario, Canada, N2J 1C4
XLR8 Medical Research /ID# 153858
Windsor, Ontario, Canada, N8W 1E6
Windsor Clinical Research, Inc /ID# 153877
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Innovaderm Research Inc. /ID# 153846
Montreal, Quebec, Canada, H2K 4L5
Ctr Derma du QC Metropolitain /ID# 153856
Quebec City, Quebec, Canada, G1V 4X7
Czechia
CCBR Clinical Research Brno /ID# 153887
Brno, Czechia, 602 00
Dermamedica, s. r. o. /ID# 153890
Nachod, Czechia, 547 01
Clinic of dermatology VZHLED /ID# 153898
Orlova - Lutyne, Czechia, 735 14
Dermatovenerology and Correcti /ID# 153888
Prague 1, Czechia, 110 00
Clintrial s.r.o. /ID# 153889
Prague, Czechia, 100 00
CCBR Czech Prague s.r.o. /ID# 153897
Prague, Czechia, 130 00
Finland
Terveystalo Tampere /ID# 154118
Tampere, Finland, 33100
Mehilainen Turku /ID# 154120
Turku, Finland, 20100
France
Charles Nicolle CHU Rouen /ID# 205842
Rouen CEDEX, Seine-Maritime, France, 76031
Hopital de L'archet 2 /ID# 153948
Nice, France, 06202
Hopital Larrey /ID# 153951
Toulouse, France, 31059
Germany
Universitaetsklinik Heidelberg /ID# 153910
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Universitaetsklinikum Erlangen /ID# 154093
Erlangen, Bayern, Germany, 91054
Universitatsklinikum Frankfurt /ID# 153891
Frankfurt, Hessen, Germany, 60590
Universitatsklinikum Munster /ID# 153895
Munster, Niedersachsen, Germany, 48149
CMS3 Company for Medical Study /ID# 201318
Selters (Westerwald), Rheinland-Pfalz, Germany, 56242
Universitaetsklinikum Leipzig /ID# 153909
Leipzig, Sachsen, Germany, 04103
Univ Hosp Schleswig-Holstein /ID# 153916
Kiel, Schleswig-Holstein, Germany, 24105
Medizinisches Versorgungszentrum DermaKiel GmbH /ID# 201316
Kiel, Schleswig-Holstein, Germany, 24148
Charité Universitätsmedizin Campus Mitte /ID# 153896
Berlin, Germany, 10117
ISA GmbH /ID# 153907
Berlin, Germany, 10789
Hautzentrum Niesmann Othlingha /ID# 154289
Bochum, Germany, 44803
Universitaetsklinikum Bonn /ID# 154094
Bonn, Germany, 53113
Klinikum Darmstadt GmbH /ID# 153893
Darmstadt, Germany, 64297
Universitaetklinikum Dresden /ID# 153906
Dresden, Germany, 01307
Universitaetsmedizin Goettinge /ID# 154091
Göttingen, Germany, 37075
Univ Klinik Eppendorf Hamburg /ID# 154089
Hamburg, Germany, 20246
Klinische Forschung GmbH /ID# 154290
Hamburg, Germany, 20253
TFS Trial Form Support GmbH /ID# 153894
Hamburg, Germany, 20354
Drs Scholz/Sebastian/Schilling /ID# 153892
Mahlow, Germany, 15831
Univ Johannes Gutenberg /ID# 154092
Mainz, Germany, 55131
TU Uniklinik Munchen /ID# 153915
Munich, Germany, 80802
Klinische Forschung Schwerin /ID# 154291
Schwerin, Germany, 19055
Universitatsklinikum Tubingen /ID# 153912
Tuebingen, Germany, 72076
Hoffmann, Witten, DE /ID# 153917
Witten, Germany, 58453
Centroderm Wuppertal /ID# 153914
Wuppertal, Germany, 42287
Japan
Nagoya City University Hospital /ID# 153866
Nagoya-shi, Aichi, Japan, 467-8602
Fukuoka University Hospital /ID# 153864
Fukuoka-shi, Fukuoka, Japan, 814-0180
Kurume University Hospital /ID# 156320
Kurume-shi, Fukuoka, Japan, 830-0011
Gifu University Hospital /ID# 169410
Gifu-shi, Gifu, Japan, 501-1194
JR Sapporo Hospital /ID# 201963
Sapporo-shi, Hokkaido, Japan, 060-0033
Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 154083
Sapporo-shi, Hokkaido, Japan, 060-0063
Kobe University Hospital /ID# 170706
Kobe, Hyogo, Japan, 650-0017
Iwate Medical University Hospital /ID# 170843
Morioka-shi, Iwate, Japan, 020-8505
Kagawa University Hospital /ID# 168656
Kita-gun, Kagawa, Japan, 761-0793
Japan Organization of Occupational Health and Society Kanto Rosai Hospital /ID# 169172
Kawasaki-shi, Kanagawa, Japan, 211-8510
National Hospital Organization Sagamihara National Hospital /ID# 153867
Sagamihara-shi, Kanagawa, Japan, 252-0315
Yokohama City University Hospital /ID# 168831
Yokohama-shi, Kanagawa, Japan, 2360004
University Hospital Kyoto Prefectural University of Medicine /ID# 169415
Kyoto-shi, Kyoto, Japan, 602 8566
Mie University Hospital /ID# 156317
Tsu-shi, Mie, Japan, 514-8507
Tohoku University Hospital /ID# 169006
Sendai-shi, Miyagi, Japan, 980-8574
Shinshu University Hospital /ID# 170937
Matsumoto-shi, Nagano, Japan, 〒390-8621
Nagasaki University Hospital /ID# 170219
Nagasaki-shi, Nagasaki, Japan, 852-8501
Okayama University Hospital /ID# 200631
Okayama-shi, Okayama, Japan, 700-8558
Kansai Medical University Hospital /ID# 170884
Hirakata-shi, Osaka, Japan, 573-1191
Osaka City University Hospital /ID# 153869
Osaka-shi, Osaka, Japan, 545-0051
Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 156319
Osaka-shi, Osaka, Japan, 550-0006
Kinki University -Osakasayama Campus /ID# 153865
Osakasayama-shi, Osaka, Japan, 589-8511
Osaka University Hospital /ID# 156321
Suita-shi, Osaka, Japan, 565-0871
Hamamatsu University Hospital /ID# 170132
Hamamatsu-shi, Shizuoka, Japan, 431-3192
Jichi Medical University Hospital /ID# 154286
Shimotsuke-shi, Tochigi, Japan, 329-0498
Tokyo Teishin Hospital /ID# 165912
Chiyoda-ku, Tokyo, Japan, 102-8798
St.Luke's International Hospital /ID# 153863
Chuo-ku, Tokyo, Japan, 104-8560
Teikyo University Hospital /ID# 154287
Itabashi-ku, Tokyo, Japan, 173-8605
NTT Medical Center Tokyo /ID# 154082
Shinagawa-ku, Tokyo, Japan, 141-8625
Tokyo Medical University Hospital /ID# 153874
Shinjuku-ku, Tokyo, Japan, 160-0023
Fukushima Med Univ Hosp /ID# 153873
Fukushima-shi, Japan, 960-1295
Kyoto University Hospital /ID# 156318
Sakyo-ku, Japan, 606-8507
Hokkaido University Hospital /ID# 154285
Sapporo, Japan, 060-8648
The Jikei University Hospital /ID# 154080
Tokyo, Japan, 105-8461
Juntendo University Hospital /ID# 200292
Tokyo, Japan, 113-8431
Nippon Medical School Hospital /ID# 154084
Tokyo, Japan, 113-8602
Tokyo Yamate Medical Center /ID# 153868
Tokyo, Japan, 169-0073
Nihon University Itabashi Hosp /ID# 154081
Tokyo, Japan, 173-0032
Yamaguchi University Hospital /ID# 156322
UBE, Japan, 755-0046
Korea, Republic of
Pusan National University Hosp /ID# 153485
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Gachon University Gil Medical Center /ID# 153489
Incheon, Incheon Gwang Yeogsi, Korea, Republic of, 21565
Chonnam National University Hospital /ID# 153488
Gwangju, Jeonranamdo, Korea, Republic of, 61469
Konkuk University Medical Ctr /ID# 153483
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
Samsung Medical Center /ID# 153487
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
St. Mary's Hospital of the Cat /ID# 153486
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
Korea Universtiy Guro Hospital /ID# 153490
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Seoul National University Hospital /ID# 153484
Seoul, Korea, Republic of, 03080
Seoul National University Hospital /ID# 153491
Seoul, Korea, Republic of, 03080
Mexico
Derma Norte del Bajio S.C. /ID# 153880
Aguascalientes, Mexico, AGS 20127
Hosp Univ Jose Eleuterio Gonza /ID# 153882
Monterrey, Mexico, 64460
Centro de Dermatologia de Mont /ID# 153881
Monterrey, Mexico, N.L 64460
Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153473
Wrocław, Dolnoslaskie, Poland, 50-368
Pratia MCM Krakow /ID# 153472
Krakow, Malopolskie, Poland, 30-510
Uniwersyteckie Centrum Kliniczne /ID# 153471
Gdansk, Mazowieckie, Poland, 80-214
Przychodnia Specjalistyczna High-Med /ID# 153468
Warsaw, Mazowieckie, Poland, 01-817
Klinika Ambroziak Sp. z o.o. /ID# 153467
Warsaw, Mazowieckie, Poland, 02-758
Osteo-Medic S.C. /ID# 156535
Białystok, Podlaskie, Poland, 15-351
Centrum Badań Klinicznych Pi-House /ID# 153884
Gdansk, Pomorskie, Poland, 80-546
Dermoklinika Medical Center /ID# 153470
Lodz, Poland, 90-436
KO-MED Centra Kliniczne Lublin /ID# 153469
Lublin, Poland, 20-362
SOLUMED Sp. z o.o., Sp.k. /ID# 153466
Poznan, Poland, 60-529
Portugal
CCA Braga - Hospital de Braga /ID# 156323
Braga, Portugal, 4710-243
Centro Hospitalar Lisboa Norte, EPE /ID# 153462
Lisboa, Portugal, 1649-035
CHP, EPE- Hospital Geral de Sa /ID# 153464
Porto, Portugal, 4050
Centro Hospitalar de Sao Joao, EPE /ID# 153463
Porto, Portugal, 4200-319
Spain
Hosp Santa Creu i Sant Pau /ID# 154125
Barcelona, Spain, 08026
Hospital Univ Germans Trias I /ID# 153465
Barcelona, Spain, 08916
Hospital Infanta Leonor /ID# 154121
Madrid, Spain, 28031
Hospital General U de Valencia /ID# 154126
Valencia, Spain, 46014
Sweden
Hudkliniken SU/Sahlgrenska /ID# 154132
Goteborg, Sweden, 41345
Karolinska Univ Sjukhuset /ID# 154131
Solna, Sweden, 17176
Sodersjukhuset /ID# 154130
Stockholm, Sweden, 11883
Taiwan
National Cheng Kung University Hospital /ID# 154135
Tainan City, Tainan, Taiwan, 70403
National Taiwan Univ Hosp /ID# 154136
Taipei City, Taipei, Taiwan, 10002
Taipei Med Univ Shuang Ho Hosp /ID# 154134
New Taipei City, Taiwan, 23561
Taiwan Adventist Hospital /ID# 154137
Taipei, Taiwan, 105
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03047395     History of Changes
Other Study ID Numbers: M15-997
2016-003046-87 ( EudraCT Number )
1311.31 ( Other Grant/Funding Number: Boehringer Ingelheim )
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (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 and 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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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

Keywords provided by AbbVie:
ABBV-066
BI 655066

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs