Clinical trial NCT04987307: Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
UC
Efavaleukin Alfa
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC).

Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.


Eligibility criteria: Key Inclusion Criteria:

* Participant has provided informed consent prior to initiation of any study specific activities or procedures.
* Men and women aged ≥ 18 to \< 80 years at screening visit (≥ 19 to \< 80 in South Korea).
* Diagnosis of UC established ≥ 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. If a histopathology report is not available at screening, then additional biopsies may be taken during the screening period for local histopathology analysis to corroborate.
* Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy subscore ≥ 2.
* Has documentation of:

  * A surveillance colonoscopy (performed according to local standard) within 12 months of day 1 visit for participants with pancolitis of \> 8 years duration, or participants with left-sided colitis of \> 12 years duration, or participants with primary sclerosing cholangitis.
  * At the discretion of the investigator, a colonoscopy (instead of a rectosigmoidoscopy) may be performed as the screening endoscopy for this study.
  * For all other participants, up-to-date colorectal cancer surveillance (performed according to local standard). Participants who do not have a colonoscopy report available in source documentation will have a colonoscopy instead of rectosigmoidoscopy performed as the screening endoscopy for the study.
* Participants must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, Janus kinase \[JAK\]-inhibitor or or S1P modulators), as follows:

  1. Conventional therapy failed participants:

     * Corticosteroids (corticosteroid-refractory colitis, defined as signs and/or symptoms of active UC despite oral prednisone \[or equivalent\] at doses of at least 30 mg/day for a minimum of 2 weeks; or corticosteroid-dependent colitis, defined as: an inability to reduce corticosteroids below the equivalent of prednisone 10 mg/day within 3 months of starting corticosteroids without a return of signs and/or symptoms of active UC; or a relapse within 3 months of completing a course of corticosteroids).
     * History of intolerance of corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/ osteoporosis, hyperglycemia, or neuropsychiatric side-effects, including insomnia, associated with corticosteroid treatment).
     * Immunomodulators: signs and/or symptoms of persistently active disease despite at least 3 months treatment with one of the following at locally approved doses: oral azathioprine (eg, ≥ 1.5 mg/kg/day) or 6-mercaptopurine (eg, ≥ 0.75 mg/kg/day), or oral azathioprine or 6-mercatopurine within a therapeutic range as judged by thioguanine metabolite testing, or a combination of a thiopurine and allopurinol within a therapeutic range as judged by thioguanine metabolite testing.
     * History of intolerance to at least 1 immunomodulator (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, and lymphopenia) and have neither failed nor demonstrated an intolerance to a biological medication (anti-tumor necrosis factor \[TNF\] antibody, anti-integrin antibody, or interleukin \[IL\]-12/23 antagonists) that is indicated for the treatment of UC.
  2. Biologic or targeted small molecule therapy failed participants: those who demonstrated inadequate response or loss of response or intolerance to biologic therapy for UC (eg, anti-TNF antibodies or IL-12/23 antagonists, anti-integrin antibodies) or targeted small molecules (eg, JAK inhibitors or S1P modulators). The therapy used to qualify the participant for entry into this category must be approved for the treatment of UC in the country of use, at the time of use. Participants must fulfil one of the following criteria:

     * Inadequate response: signs and symptoms of persistently active disease despite induction treatment at the approved induction dosing that was indicated in the product label at the time of use.
     * Loss of response: recurrence of signs and symptoms of active disease during approved maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not quality as having failed or being intolerant to UC biological therapy, JAK inhibitor, or S1P modulators).
     * Intolerance: history of intolerance to infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib or other approved biologicals, JAK inhibitors or S1P modulators (including but not limited to infusion-related event, demyelination, congestive heart failure, or any other drug-related adverse event that led to a reduction in dose or discontinuation of the medication).
* If receiving any of the following therapies, participants must have stable dosage for the specified duration:

  * 5-aminosalicylates (ASAs), stable dosage for ≥ 2 weeks prior to screening endoscopy.
  * Oral corticosteroids: prednisone ≤ 20 mg/day or its equivalent, stable dose for ≥ 2 weeks prior to screening endoscopy.
  * Budesonide: extended release tablets 9 mg/day \[budensonide MMX\], stable dose for ≥ 2 weeks prior to screening endoscopy.
  * Beclomethasone dipropionate: gastro-resistant prolonged-release tablet 5 mg/day, stable dose for \>= 2 weeks prior to screening endoscopy.
  * Conventional immunomodulators: azathioprine, 6-mercaptopurine, methotrexate, stable dosage for ≥ 12 weeks prior to screening endoscopy.

Key Exclusion Criteria:

* Diagnosis of Crohn's disease, inflammatory bowel disease unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn's disease.
* Evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
* Participant has had extensive surgery for UC (for example, subtotal colectomy), or is likely to require surgery for the treatment of UC during the study.
* Currently receiving or had treatment within 12 months prior to screening with T cell depleting agents (eg, antithymocyte globulin, Campath).
* Participant has received any of the following prescribed medication or therapy within the specified time period:

  * Anti TNF antibodies (eg, infliximab, adalimumab, golimumab) \< 8 weeks prior to screening rectosigmoidoscopy.
  * Anti integrin antibodies (eg, vedolizumab) \< 8 weeks prior to screening rectosigmoidoscopy.
  * IL 12/23 antagonist (eg, ustekinumab) \< 8 weeks prior to screening rectosigmoidoscopy.
  * JAK inhibitors (eg, tofacitinib) \< 4 weeks prior to screening rectosigmoidoscopy.
  * Any other commercially approved biologic agent or targeted small molecule \< 8 weeks prior to screening rectosigmoidoscopy or \< 5 half lives prior to screening rectosigmoidoscopy, whichever is longer
  * Immunomodulatory medications, including oral cyclosporine, intravenous cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, thalidomide \< 4 weeks prior to screening rectosigmoidoscopy.
  * Any investigational biologic therapy within 8 weeks prior to screening rectosigmoidoscopy or \< 5 half-lives prior to screening rectosigmoidoscopy, whichever is longer.
  * Has used apheresis (eg, Adacolumnâ apheresis) \< 2 weeks prior to screening rectosigmoidoscopy.

Primary outcomes:
measure: Number of Participants with Clinical Remission at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants with Clinical Response at Week 12
timeFrame: Week 12
measure: Number of Participants with Endoscopic Remission at Week 12
timeFrame: Week 12
measure: Number of Participants with Symptomatic Remission at Week 12
timeFrame: Week 12
measure: Number of Participants with Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12
timeFrame: Week 12
measure: Number of Participants with a Clinically Significant Change from Baseline in Histological Score at Week 12 as Measured by Geboes Score
timeFrame: Baseline to Week 12
measure: Number of Participants who Experience One or More Treatment-emergent Adverse Events
timeFrame: Up to 56 weeks
Other outcomes:
Locations:
city: Dothan
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facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Homewood
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facility: Birmingham Digestive Health Research, LLC
state: Alabama
city: Mesa
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facility: Arizona Health Research
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city: Phoenix
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facility: Southern California Research Center
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city: Los Angeles
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facility: Biopharma Informatic Incorporated
state: California
city: Los Angeles
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facility: Gastrointestinal Biosciences Clinical Trials Limited Liability Company
state: California
city: Orange
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facility: University of California Irvine
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city: Santa Maria
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facility: Santa Maria Gastroenterology Medical Group
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city: Thousand Oaks
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facility: Clinical Trials Management Services LLC
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city: Hamden
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city: Homestead
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city: Lady Lake
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facility: Lake Center for Clinical Research
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city: Lakeland
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facility: Auzmer Research
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city: Miami
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facility: University of Miami Hospital and Clinic
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city: Ocala
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facility: Ocala Gastrointestinal Research, LLC
state: Florida
city: Orlando
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facility: AdventHealth Medical Group Gastroenterology and Hepatology
state: Florida
city: Sanford
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facility: Infigo Clinical Research
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city: Atlanta
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facility: Atlanta Gastroenterology Associates
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city: Columbus
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facility: Columbus Regional Research Institute, LLC
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city: Idaho Falls
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facility: Grand Teton Research Group
state: Idaho
city: Chicago
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facility: Rush University Medical Center
state: Illinois
city: South Bend
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facility: Digestive Research Alliance of Michiana
state: Indiana
city: Kansas City
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facility: University of Kansas Medical Center
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city: Greenbelt
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facility: Mid-Atlantic GI Research, LLC
state: Maryland
city: Boston
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facility: Harvard Medical School - Brigham and Womens Hospital
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city: Worcester
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facility: University of Massachusetts Memorial Medical Center
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city: Troy
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city: Wyoming
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city: Jackson
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city: Columbia
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facility: Gastrointestinal Associates Research, LLC
state: Missouri
city: Liberty
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city: Morristown
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facility: Atlantic Digestive Health Institute
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city: Sparta
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city: Springboro
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facility: Digestive Specialists Inc Research, LLC
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city: Oklahoma City
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facility: Hightower Clinical
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city: Tulsa
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facility: Options Health Research, LLC
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city: Sayre
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facility: Guthrie Robert Packer Hospital
state: Pennsylvania
city: Charleston
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facility: Medical University of South Carolina
state: South Carolina
city: Columbia
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facility: Columbia Digestive Health Research LLC
state: South Carolina
city: Chattanooga
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facility: Wake Research-ClinSearch, LLC
state: Tennessee
city: Hermitage
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facility: Digestive Health Research, LLC
state: Tennessee
city: El Paso
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facility: Great Lakes Research Insititute El Paso Research
state: Texas
city: Houston
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facility: Digestive Health Associates
state: Texas
city: Waco
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facility: Digestive Research of Central Texas, LLC
state: Texas
city: Wichita Falls
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facility: Digestive Health Research of North Texas LLC
state: Texas
city: Lansdowne Town Center
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facility: Emeritas Research Group
state: Virginia
city: Lynchburg
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facility: Blue Ridge Medical Research
state: Virginia
city: Richmond
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facility: North Richmond Health Research
state: Virginia
city: Richmond
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facility: GI Select Health Research LLC
state: Virginia
city: Richmond
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facility: Hunter Holmes McGuire Veterans Affairs Medical Center
state: Virginia
city: Milwaukee
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facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
state: Buenos Aires
city: Munro
country: Argentina
facility: Clinica Independencia
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Cer Instituto Medico
state: Buenos Aires
city: San Isidro
country: Argentina
facility: CardioAlem Investigaciones
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba SA
state: Córdoba
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos
state: Santa Fe
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Wien
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facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
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city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Sofia
country: Bulgaria
facility: Second Multiprofile Hospital for Active Treatment - Sofia EAD
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Convex EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment Mladost EOOD
city: Edmonton
country: Canada
facility: South Edmonton Gastroenterology
state: Alberta
city: London
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facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Toronto
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facility: TIDHI Innovation Incorporated
state: Ontario
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK sro
city: Pardubice
country: Czechia
facility: Nemocnice Pardubickeho kraje as, Pardubicka nemocnice
city: Praha
country: Czechia
facility: Nemocnice Milosrdnych sester sv Karla Boromejskeho v Praze
city: Praha
country: Czechia
facility: Axon Clinical sro
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Kobenhavn NV
country: Denmark
facility: Bispebjerg Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Amiens cedex 1
country: France
facility: Centre Hospitalier Universitaire Amiens Picardie
city: Montpellier cedex 5
country: France
facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
city: Neuilly sur seine
country: France
facility: Centres Medicaux Chirurgicaux Ambroise Pare Hartmann
city: Nice cedex 3
country: France
facility: Centre Hospitalier Universitaire Archet 2
city: Saint Priest en Jarez
country: France
facility: Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord
city: Vandoeuvre les Nancy Cedex
country: France
facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
city: Berlin
country: Germany
facility: Gastro-Studien GbR Studienzentrum
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Alexandroupoli
country: Greece
facility: University General Hospital of Alexandroupolis
city: Athens
country: Greece
facility: General Hospital Evangelismos
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Haidari
country: Greece
facility: University Hospital Attikon
city: Heraklion
country: Greece
facility: Venizeleio General Hospital
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Patras
country: Greece
facility: General University Hospital of Patras Panagia i Voithia
city: Bekescsaba
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz
city: Budapest
country: Hungary
facility: MIND Klinika Kft
city: Budapest
country: Hungary
facility: Clinexpert Kft
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
city: Szekszard
country: Hungary
facility: Clinfan Kft
city: Tatabanya
country: Hungary
facility: Komarom-Esztergom Varmegyei Szent Borbala Korhaz
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Universitaria Renato Dulbecco
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Genoa
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Negrar VR
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Kashiwa-shi
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
state: Chiba
city: Sakura-shi
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Kitakyushu-shi
country: Japan
facility: Kitakyushu Municipal Medical Center
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
state: Gifu
city: Hashima-gun
country: Japan
facility: Matsunami General Hospital
state: Gifu
city: Hakodate-shi
country: Japan
facility: Hakodate Central General Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Tokushukai Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Aoyama Clinic GI Endoscopy and IBD Center
state: Hyogo
city: Kamakura-shi
country: Japan
facility: Gokeikai Ofuna Chuo Hospital
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Takagi Clinic
state: Miyagi
city: Miyazaki-shi
country: Japan
facility: Miyazaki Prefectural Miyazaki Hospital
state: Miyazaki
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Kashihara-shi
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Okayama-shi
country: Japan
facility: National Hospital Organization Okayama Medical Center
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Ome-shi
country: Japan
facility: Ome Medical Center
state: Tokyo
city: Toshima-ku
country: Japan
facility: Medical Corporation ENEXT Ikebukuro West Gate Hospital
state: Tokyo
city: Kofu-shi
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Wonju-si, Gangwon-do
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Gastro Centrs
city: Ciudad de Mexico
country: Mexico
facility: Clinicos Asociados BOCM SC
state: Distrito Federal
city: Guadalajra
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad SC
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
state: Jalisco
city: Monterrey
country: Mexico
facility: CRI Centro Regiomontano de Investigacion SC
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital San Jose Tec Salud Fundacion Santos y de la Garza Evia IBP
state: Nuevo León
city: Culiacan
country: Mexico
facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC
state: Sinaloa
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Tilburg
country: Netherlands
facility: Elisabeth TweeSteden Ziekenhuis
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Elblag
country: Poland
facility: NZOZ Twoje Zdrowie EL Spzoo
city: Lodz
country: Poland
facility: Centrum Medyczne Med-Gastr Sp zoo
city: Malbork
country: Poland
facility: Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
city: Poznan
country: Poland
facility: Oleg Tyszkiwski Centrum Gastrologiczne Gorczyn Oleg Tyszkiwski
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Warszawa
country: Poland
facility: BodyClinic spolka z ograniczona odpowiedzialnoscia
city: Wroclaw-Krzyki
country: Poland
facility: Centrum Medyczne Melita Medical
city: Wroclaw
country: Poland
facility: EuroMediCare Przychodnia Specjalistyczna we Wroclawiu
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Militar Central Dr Carol Davila
city: Bucuresti
country: Romania
facility: Clinica Medicum
city: Bucuresti
country: Romania
facility: Memorial Healthcare International SRL
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Oradea
country: Romania
facility: Spitalul Clinic Pelican
city: Banska Bystrica
country: Slovakia
facility: Fakultna Nemocnica s poliklinikou FD Roosevelta Banska Bystrica
city: Kosice
country: Slovakia
facility: Endomed, sro
city: Presov
country: Slovakia
facility: Gastro I, sro
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Bern
country: Switzerland
facility: Intesto BE
city: Sankt Gallen
country: Switzerland
facility: Kantonsspital St Gallen
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Antalya
country: Turkey
facility: Antalya Egitim ve Arastirma Hastanesi
city: Bursa
country: Turkey
facility: Uludag Universitesi Tip Fakultesi Hastanesi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi Hastanesi
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: