Study Stopped
The study was terminated due to a strategic business decision made by the Sponsor.
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3
3 other identifiers
interventional
1,936
19 countries
229
Brief Summary
The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2018
Typical duration for phase_3
229 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2018
CompletedFirst Posted
Study publicly available on registry
June 14, 2018
CompletedStudy Start
First participant enrolled
September 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2022
CompletedResults Posted
Study results publicly available
March 21, 2023
CompletedMarch 21, 2023
March 1, 2023
3.4 years
June 4, 2018
February 3, 2023
March 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1
The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.
Week 104
Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Week 104
Secondary Outcomes (6)
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Week 104
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline
Week 104
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5
Week 104
Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
Baseline, Week 104
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
Baseline, Week 104
- +1 more secondary outcomes
Study Arms (3)
125 Milligram (mg) Mirikizumab Q8W
EXPERIMENTALParticipants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
250 mg Mirikizumab Q8W Excluding Secukinumab
EXPERIMENTALParticipants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ)
Secukinumab/250 mg Mirikizumab Q8W
EXPERIMENTALParticipants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Participant must have completed the last visit of an eligible study period of originating study.
- Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential.
You may not qualify if:
- Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study.
- Participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (229)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Zenith Research, Inc.
Beverly Hills, California, 90212, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Keck School of Medicine University of Southern California
Los Angeles, California, 90033, United States
Dermatology Clinical Trials
Newport Beach, California, 92660-7831, United States
San Luis Dermatology & Laser Clinic
San Luis Obispo, California, 93405, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Univ of Connecticut
Farmington, Connecticut, 06030-2840, United States
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
Dermatologic Surgery Specialists, PC
Macon, Georgia, 31217, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Advanced Clinical Research LLC
Meridian, Idaho, 83642, United States
University Dermatology
Darien, Illinois, 60561, United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
The South Bend Clinic Center for Research
South Bend, Indiana, 46617, United States
Forefront Research
Louisville, Kentucky, 40241, United States
DelRicht Research
Baton Rouge, Louisiana, 70809, United States
Dermatology and Skin Cancer Specialists
Rockville, Maryland, 20850, United States
Lawrence J Green, M.D, LLC
Rockville, Maryland, 20850, United States
ORA, Inc
Andover, Massachusetts, 01810, United States
Central Dermatology PC
St Louis, Missouri, 63117, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Mount Sinai School of Medicine Dermatology Clinical Trials
New York, New York, 10029, United States
PMG Research of Cary, LLC
Cary, North Carolina, 27518, United States
University of North Carolina Dermatology and Skin Cancer Cen
Chapel Hill, North Carolina, 27516, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28411, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Wright State Univ School of Medicine
Fairborn, Ohio, 45324, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, 19341, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
Modern Research Associates
Dallas, Texas, 75231, United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
University of Utah
Murray, Utah, 84107, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
Dermatology Associates
Seattle, Washington, 98101, United States
MultiCare Good Samaritan Hospital
Tacoma, Washington, 98405, United States
Dermatology
CABA, Buenos Aires, C1060ABN, Argentina
Instituto de Neumonología Y Dermatología
Capital Federal, Buenos Aires, 1425, Argentina
Psoriahue
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425DKG, Argentina
Buenos Aires Skin
Buenos Aires, Ciudad Autónoma de Buenos Aire, 1055, Argentina
Clinica Adventista Belgrano
CABA, Ciudad Autónoma de Buenos Aire, C1430EGF, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1027AAP, Argentina
Halitus Instituto Médico
Ciudad Autonoma de Buenos Aire, C1122AAF, Argentina
Parra Dermatología
Mendoza, 5500, Argentina
Woden Dermatology
Phillip, Australian Capital Territory, 2606, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102, Australia
Clinical Trials SA Pty Ltd
Adelaide, South Australia, 5073, Australia
Skin Health Institute Inc.
Carlton, Victoria, 3053, Australia
Fremantle Dermatology
Perth, Western Australia, 6160, Australia
Kirk Barber Research
Calgary, Alberta, T2G 1B1, Canada
Alberta DermaSurgery Centre
Edmonton, Alberta, T6G 1C3, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7, Canada
Eastern Canada Cutaneous Research Assoicates Ltd
Halifax, Nova Scotia, B3H1Z2, Canada
Guenther Research Inc.
London, Ontario, N6A 3H7, Canada
Lynderm Research Inc.
Markham, Ontario, L3P1X2, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
Innovaderm Research Inc
Montreal, Quebec, H2X 2V1, Canada
Kožní ambulance Kutná Hora, s.r.o.
Kutná Hora, Central Bohemia, 28401, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Hl. M. Praha, 100 34, Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, Moravskoslezský kraj, 741 01, Czechia
Clintrial s.r.o.
Prague, Praha 10, 100 00, Czechia
Fakultni Nemocnice U svate Anny
Brno, South Moravian, 656 91, Czechia
Etická komise Krajské zdravotní, a.s. - Masarykovy nemocnice v Ústí nad Labem, o.z.
Ústí nad Labem, Ustecký Kraj, 40113, Czechia
CHU Dupuytren 2
Limoges, Cedex, 87042, France
CHU de Bordeaux Hop St ANDRE
Bordeaux, Gironde, 33075, France
CH du Mans - Pavillon Claude Monet
Le Mans, 72037, France
Cabinet Médical
Martigues, 13500, France
Hopital Saint Eloi
Montpellier, 34295, France
CHU de Nice Hopital de L'Archet
Nice, 06202, France
CHU Charles Nicolle in Rouen
Rouen, 76036, France
Hopital Larrey
Toulouse, 31059, France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Hautarztpraxis Dr. Leitz
Stuttgart, Baden-Wurttemberg, 70178, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Dermatologische Gemeinschaftspraxis Mahlow
Mahlow, Brandenburg, 15831, Germany
Rosenpark Research GmbH
Darmstadt, Hesse, 64283, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Lower Saxony, 48455, Germany
Dermatologisches Zentrum Osnabrück Nord
Bramsche, Lower Saxony, 49565, Germany
Elbe Klinikum Buxtehude
Buxtehude, Lower Saxony, 21614, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Hautarztpraxis Dr. Gerlach
Dresden, Saxony, 01097, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
Charité Campus Virchow-Klinikum
Berlin, 10117, Germany
Klin. Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
Rothhaar Studien
Berlin, 10783, Germany
ISA GmbH
Berlin, 10789, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
TFS Trial Form Support GmbH
Hamburg, 20537, Germany
Clinical Research Hamburg GmbH
Hamburg, 22143, Germany
Oroshaza Varosi Onkormanyzat Korhaza
Orosháza, Bekes County, 5900, Hungary
Bacs-Kiskun Megyei Korhaz
Kecskemét, Bács-Kiskun county, 6000, Hungary
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen, Hajdú-Bihar, 4032, Hungary
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
Medmare Bt
Veszprém, Veszprém City, 8200, Hungary
Uno Medical Trials Kft.
Budapest, 1152, Hungary
Ambrozia Kft.
Budapest, 1238, Hungary
Haemek Medical Center- Dermatology
Afula, 1834111, Israel
Soroka Medical Center
Beersheba, 8410101, Israel
Rambam Medical Center
Haifa, 3525408, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Policlinico Gemelli - Università Cattolica del Sacro Cuore
Rome, Lazio, 00168, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Presidio Ospedaliero Firenze Centro Piero Palagi
Florence, 50125, Italy
Policlinico di Tor Vergata
Roma, 00133, Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Toho University School of Medicine, Sakura Hospital
Sakura, Chiba, 285-8741, Japan
Juntendo Urayasu Hospital
Urayasu, Chiba, 279-0021, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Gunma University Hosptial
Maebashi, Gunma, 371-8511, Japan
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, 078-8510, Japan
Takagi Dermatology
Obihiro, Hokkaido, 080-0013, Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki, Ibaraki, 300-0332, Japan
Tokai University Hospital- Isehara Campus
Isehara, Kanagawa, 259-1143, Japan
Kanto Rosai Hospital
Kawasaki, Kanagawa, 211-8510, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Shinshu University Hospital
Matsumoto, Nagano, 390-8621, Japan
Ryukyu University Hospital
Nakagami-gun, Okinawa, 903-0215, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Kume Clinic
Nishi-ku Sakai-shi, Osaka, 593 8324, Japan
Shiga University of Medical Science Hosptial
Ōtsu, Shiga, 520-2192, Japan
Shimane University Hospital
Izumo, Shimane, 693-0021, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655, Japan
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, 193-0998, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, 173 8606, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610, Japan
NTT Medical Center Tokyo
Shinagawa-KU, Tokyo, 141-8625, Japan
Showa University Hospital
Shinagawa, Tokyo, 142-8555, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
Seibo Hospital
Shinjuku-ku, Tokyo, 161-8521, Japan
Takaokashi Shirasaki Dermatology Clinic
Takaoka, Toyama, 933-0871, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506, Japan
Gifu University Hospital
Gifu, 501-1194, Japan
Kyoto Furitsu Medical University Hospital
Kyoto, 602-8566, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Nippon Life Hospital
Osaka, 550-0006, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
St. Luke's International Hospital
Tokyo, 104-8560, Japan
Wakayama Medical University Hospital
Wakayama, 641-0012, Japan
Centro Medico del Angel
Mexicali, Estado de Baja California, 21100, Mexico
Grupo Clinico CATEI Sociedad Civil
Guadalajara, Jalisco, 44657, Mexico
Hospital de Jesus I.A.P.
Mexico City, Mexico City, 06090, Mexico
Clinica De Enfermedades Cronicas y Procedimientos Especiales
Morelia, Michoacán, 58249, Mexico
B&B Investigaciones Medicas, SC
Mazatlán, Sinaloa, 82140, Mexico
Köhler & Milstein Research
Mérida, Yucatán, 97070, Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal, 3100, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, 34000, Mexico
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
Poznan, Greater Poland Voivodeship, 61-113, Poland
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031, Poland
Diamond Clinic
Krakow, Lesser Poland Voivodeship, 31-559, Poland
dermMedica Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, 51-318, Poland
Lubelskie Centrum Diagnostyczne
Świdnik, Lublin Voivodeship, 21-040, Poland
Centrum Medyczne AMED
Warsaw, Masovian Voivodeship, 01-518, Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, 02-625, Poland
NZOZ ZDROWIE Osteo-Medic
Bialystok, Podlaskie Voivodeship, 15-351, Poland
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm
Bialystok, Podlaskie Voivodeship, 15-375, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611, Poland
LASER CLINIC Specjalistyczne Gabinety Lekarskie
Szczecin, West Pomeranian Voivodeship, 70-332, Poland
Centralny Szpital Kliniczny MSW Klinika Dermatologii
Warsaw, 02-507, Poland
Dermed Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, 90-265, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, Łódź Voivodeship, Poland
Dr. Samuel Sanchez PSC
Caguas, PR, 00727, Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, PR, 00985, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, 00716, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, 00917, Puerto Rico
Santa Cruz Behavioral PSC
Bayamón, 00961-6911, Puerto Rico
GBUZ Clinical dermatology and venereological dispensary
Krasnodar, Krasnodarskiy Kray, 350020, Russia
State scientific centre for dermatovenerology and cosmetolog
Moscow, 107076, Russia
SPb SBHI Skin-venerologic dispensary #10
Saint Petersburg, 194021, Russia
GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'
Smolensk, 214000, Russia
Tver State Medical University
Tver', 170100, Russia
Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 10380, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
CHA Bundang Medical Center, CHA University
Sungnam-si, Gyeonggi-do, 13496, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Pusan National University Hospital
Busan, Korea, 49241, South Korea
Chungnam National University Hospital
Daejeon, Korea, 35015, South Korea
Chonnam National University Hospital
Gwangju, Korea, 61469, South Korea
Gachon University Gil Hospital
Incheon, Korea, 21565, South Korea
Kyung Hee University Hospital
Seoul, Korea, 02447, South Korea
Hanyang University Medical Center
Seoul, Korea, 04763, South Korea
Seoul St. Mary's Hospital
Seoul, Korea, 06591, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 6351, South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 8308, South Korea
Ulsan University Hospital
Ulsan, Ulsan-Kwangyǒkshi, 44033, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Chungang University Hospital
Seoul, 06973, South Korea
Hospital Marina Baixa
Villajoyosa, Alicante, 03570, Spain
Hospital Germans Trias i Pujol
Barcelona, Badalona, 08916, Spain
Hospital de Manises
Manises, Valencia, 46940, Spain
Hospital De Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Centro de Especialidades Mollabao
Pontevedra, 36001, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
National Taiwan University Hospital - Hsinchu branch
Hsinchu, 300, Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, 83301, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
National Cheng-Kung Uni. Hosp.
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan Hsien, 10508, Taiwan
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD, United Kingdom
Related Publications (1)
Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.
PMID: 39073712DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated before completion of the long-term extension trial, due to strategic business decision made by the company.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
1-877-CTLILLY (1-877-285-4559) or Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Initially double-blind (until original, pivotal studies AMAK \[NCT03482011\] and AMAJ \[NCT03535194\] are locked and unblinded), then open-label.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2018
First Posted
June 14, 2018
Study Start
September 3, 2018
Primary Completion
February 7, 2022
Study Completion
February 7, 2022
Last Updated
March 21, 2023
Results First Posted
March 21, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.