Clinical trial NCT03259308: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-08-23
Enrollment: 279
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Detailed description: 27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Eligibility criteria: Inclusion Criteria:

- Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.

* Participants must be able to voluntarily provide written, signed, and dated informed consent and/or assent, as applicable, to participate in the study.
* Participants less than (\<) 18 years of age must weigh \>=40 kg and must have body mass index (BMI) \>=16.5 kilogram per square metre (kg/m\^2).
* Participants must have a documented diagnosis of UC for \>=3 months before screening. The following must be available in each participant's source documentation:

  a. A biopsy report to confirm the histological diagnosis. b. A report documenting disease duration based upon prior colonoscopy. Note: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period.
* Participants must be willing to undergo a flexible sigmoidoscopy or colonoscopy, including biopsy sample collection, during screening after all other inclusion criteria have been met.
* Participants must have moderate to severe active UC, defined as a total Mayo score of \>=6, including a centrally read endoscopic subscore \>=2, rectal bleeding subscore \>=1, and stool frequency subscore \>=1 at baseline.
* Participants must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
* Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylate \[ASA\]), glucocorticoids, immunosuppressants (azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], or methotrexate \[MTX\]), or anti-tumor necrosis factor (TNF).
* Participants receiving any treatment(s) for UC are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
* Participants are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential.

Exclusion Criteria:

* Participants with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn's disease.
* Participants with colonic dysplasia or neoplasia. (Participants with prior history of adenomatous polyps will be eligible if the polyps have been completely removed.)
* Participants with past medical history or presence of toxic megacolon.
* Participants with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
* Participants at risk for colorectal cancer must have a colonoscopy performed during the screening period with results available within 10 days before the baseline visit, unless the participant has had a surveillance colonoscopy performed within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised. Colonoscopy report and pathology report (if biopsies are obtained) from the colonoscopy performed during screening or in the prior year confirming no evidence of dysplasia and colon cancer must be available in the source documents.

Participants at risk for colorectal cancer include, but are not limited to:

1. Participants with extensive colitis for \>=8 years or disease limited to left side of colon (ie, distal to splenic flexure) for \>=10 years before screening, regardless of age.
2. Participants \>=50 years of age at the time of signing of the informed consent form.

   - Participants have had prior treatment with ontamalimab (formerly PF-00547659, SHP647).

   - Participants with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.

   - Participants have received anti-TNF treatment within 60 days before baseline.

   - Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline.

   - Participants have received any nonbiologic treatment with immunomodulatory properties (other than their current background UC treatment) within 30 days before baseline.

   - Participants have ever received anti-integrin/adhesion molecule treatment (example (eg): natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule).
   * Participants have received parenteral or rectal glucocorticoids, or rectal 5-ASA, within 14 days before screening endoscopic procedure.
   * Participants have received leukocyte apheresis or selective lymphocyte, monocyte, or granulocyte apheresis or plasma exchange within 30 days before baseline.
   * Participants have participated in other investigational studies within either 30 days or 5 half-lives of investigational product used in the study (whichever is longer) before baseline.
   * Participants have received a live (attenuated) vaccine within 30 days before the baseline visit.
   * Participants with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis \[Participants with C. difficile infection at screening may be allowed re-test after treatment\], evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the participants to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit.
   * Participants with abnormal chest x-ray findings at screening, such as presence of active tuberculosis (TB), general infections, heart failure, or malignancy.
   * Participants with evidence of active or latent infection with Mycobacterium TB or participants with this history who have not completed a generally accepted full course of treatment before randomization are excluded. All other participants must have either the Mantoux (purified protein derivative \[PPD\]) tuberculin skin test or interferon gamma release assay (IGRA) performed.

Participants who have no history of previously diagnosed active or latent TB are excluded if they have a positive Mantoux (PPD) tuberculin skin test (ie \>=5 millimeter \[mm\] induration) or a positive IGRA (the latter to be tested at the site's local laboratory) during screening or within 12 weeks before screening. If IGRA test cannot be performed locally, a central laboratory may be used, with prior agreement from the sponsor.

1. An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guerin (BCG) vaccination, but may be used for any participant. Documentation of IGRA product used and the test result must be in the participant's source documentation if performed locally. Acceptable IGRA products include QuantiFERON TB Gold Plus In-Tube Test.
2. If the results of the IGRA are indeterminate, the test may be repeated, and if a negative result is obtained, enrollment may proceed. In participants with no history of treated active or latent TB, a positive test on repeat will exclude the participant. Participants with a history of active or latent TB infection must follow instructions for "Participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met" in this criterion.
3. Participants with repeat indeterminate IGRA results, with no prior TB history, may be enrolled after consultation with a pulmonary or infectious disease specialist who determines low risk of infection (ie, participant would be acceptable for immunosuppressant \[eg, anti-TNF\] treatment without additional action). This consultation must be included in source documentation.

Results from a chest x-ray, taken within the 12 weeks before or during screening must show no abnormalities suggestive of active TB infection as determined by a qualified medical specialist.

Participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met:

1. The participant has previously received an adequate course of treatment for either latent (eg, 9 months of isoniazid or an acceptable alternative regimen, in a locale where rates of primary multidrug TB resistance are \<5%. Participants from regions with higher rates of primary multidrug TB resistance are excluded) or active (acceptable multidrug regimen) TB infection. Evidence of diagnosis and treatment must be included in source documentation. Consultation with a pulmonary or infectious disease specialist to confirm adequate treatment (ie, participant would be acceptable for immunosuppressant \[eg, anti-TNF\] treatment without additional action) must be performed during the screening period. The consultation report must be included in source documentation prior to enrollment.
2. A chest x-ray performed within 12 weeks before screening or during screening indicates no evidence of active or recurrent disease, and documentation of interpretation by a qualified medical specialist must be included in source documentation.

   * Participants with a pre-existing demyelinating disorder such as multiple sclerosis or new onset seizures, unexplained sensory motor, or cognitive behavioral, neurological deficits, or significant abnormalities noted during screening.
   * Participants with any unexplained symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on the targeted neurological assessment during the screening period.
   * Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed.
   * Participants with a significant concurrent medical condition at the time of screening or baseline, including, but not limited to, the following:

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1. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic \[eg, Felty's syndrome\], or local active infection/infectious illness) that, in the investigator's judgment will substantially increase the risk to the participant if he or she participates in the study.
2. Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
3. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before screening.
4. History of significant cerebrovascular disease within 24 weeks before screening.

   - Participants who have had significant trauma or major surgery within 4 weeks before the screening visit, or with any major elective surgery scheduled to occur during the study.

   - Participants with evidence of cirrhosis with or without decompensation.

   - Participants with primary sclerosing cholangitis.

   - Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb).

   Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if no presence of hepatitis B virus (HBV) DNA is confirmed by HBV DNA polymerase chain reaction (PCR) reflex testing performed in the central laboratory.
   * Participants with chronic hepatitis C virus (HCV) (positive HCV antibody \[HCVAb\] and HCVRNA).

   Note: Participants who are HCVAb positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \[defined as no evidence of HCVRNA at least 12 weeks prior to baseline\]).
   * Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during screening.

   Note: Screening laboratory tests, if the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once during the screening period for confirmation. Results must be reviewed for eligibility prior to the screening endoscopy procedure.

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1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \>=3.0×upper limit of normal (ULN).
2. Total bilirubin level \>=1.5×ULN or \>2.0×ULN if the participant has a known documented history of Gilbert's syndrome.
3. Hemoglobin level \<=80 gram per liter (g/L) (8.0 gram per deciliter \[g/dL\]).
4. Platelet count \<=100×10\^9 per liter (/L) (100,000 cells per cubic millimeter \[mm\^3\]) or \>=1000×10\^9/L (1,000,000 cells/mm\^3).
5. White blood cell count \<=3.5×10\^9/L (3500 cells/mm\^3).

   - Absolute neutrophil count (ANC)\<2×10\^9/L (2000 cells/mm\^3).

   - Serum creatinine level \>1.5 × ULN or estimated glomerular filtration rate \<30 ml/min/1.73m\^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.

   Note: If platelet count is \<150,000 cells/mm\^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.
   * Participants with known human immunodeficiency virus (HIV) infection based on documented history, with positive serological test, or positive HIV serologic test at screening, tested at the site's local laboratory in accordance with country requirements or tested at the central laboratory.

   Note: A documented negative HIV test within 6 months of screening is acceptable and does not need to be repeated.

   - Participants who have, or who have a history of (within 2 years before screening), serious psychiatric disease, alcohol dependency, or substance/drug abuse or dependency of any kind, including abuse of medical marijuana (cannabis).

   - Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

   - Female participants who are planning to become pregnant during the study period.
   * Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
   * Participants who are investigational site staff members or relatives of those site staff members or Participants who are Shire employees directly involved in the conduct of the study.

Primary outcomes:
measure: Number of Participants With Remission Based on Composite Score at Week 12
timeFrame: At Week 12
Secondary outcomes:
measure: Number of Participants With Endoscopic Remission at Week 12
timeFrame: At Week 12
measure: Number of Participants With Clinical Remission at Week 12
timeFrame: At Week 12
measure: Number of Participants With Clinical Response Based on Composite Score at Week 12
timeFrame: At Week 12
measure: Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12
timeFrame: At Week 12
measure: Number of Participants With Remission Based on Total Mayo Score at Week 12
timeFrame: At Week 12
measure: Number of Participants With Clinical Response Based on Total Mayo Score at Week 12
timeFrame: At Week 12
measure: Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12
timeFrame: At Weeks 4, 8, and 12
measure: Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8
timeFrame: At Weeks 4 and 8
measure: Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12
timeFrame: At Week 12
measure: Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12
timeFrame: At Weeks 4, 8, and 12
measure: Number of Participants With Deep Remission at Week 12
timeFrame: At Week 12
measure: Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12
timeFrame: Baseline, Weeks 8 and 12
measure: Change From Baseline in IBDQ Total Scores at Weeks 8 and 12
timeFrame: Baseline, Weeks 8 and 12
measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants Based on Inpatient Hospitalization
timeFrame: From start of study up to follow up (Week 29)
measure: Median Duration of Total Inpatient Days
timeFrame: From start of study up to follow-up (Week 29)
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Digestive Health Mesa - East
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies - Phoenix - Clinedge - PPDS
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Encinitas
country: United States
facility: United Medical Doctors
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System - NAVREF - PPDS
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Poway
country: United States
facility: Alliance Clinical Research-(Vestavia Hills)
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Pablo
country: United States
facility: Care Access Research, San Pablo
state: California
city: Cape Coral
country: United States
facility: Renaissance Research Medical Group, INC
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Coral Gables
country: United States
facility: Hi Tech and Global Research, LLc
state: Florida
city: Jacksonville
country: United States
facility: ENCORE Borland-Groover Clinical Research - ERN - PPDS
state: Florida
city: Kissimmee
country: United States
facility: SIH Research
state: Florida
city: Lighthouse Point
country: United States
facility: Alliance Medical Research LLC
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research, Inc
state: Florida
city: Naples
country: United States
facility: Pharma Research International Inc
state: Florida
city: New Port Richey
country: United States
facility: Bayside Clinical Research - New Port Richey
state: Florida
city: Pinellas Park
country: United States
facility: Accel Research Sites - St. Petersburg - ERN - PPDS
state: Florida
city: Plantation
country: United States
facility: BRCR Medical Center Inc.
state: Florida
city: Tamarac
country: United States
facility: DBC Research
state: Florida
city: Atlanta
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center For Gastroenterology PC
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Chicago
country: United States
facility: Loretto Hospital
state: Illinois
city: Gurnee
country: United States
facility: IL Gastroenterology Group
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr VA Hospital - NAVREF - PPDS
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Dupage Medical Group
state: Illinois
city: Hazard
country: United States
facility: Gastroenterology Associates of Hazard
state: Kentucky
city: Houma
country: United States
facility: CroNOLA, LLC.
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies LLC
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Hamtramck
country: United States
facility: National Clinical, LLC
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: St Louis Center For Clinical Research
state: Missouri
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: North Las Vegas
country: United States
facility: Encompass Care
state: Nevada
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Orchard Park
country: United States
facility: Southtowns Gastroenterology, PLLC
state: New York
city: Jacksonville
country: United States
facility: East Carolina Gastroenterology
state: North Carolina
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Mentor
country: United States
facility: Ohio Clinical Research Partners LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Veteran's Research and Education Foundation - NAVREF - PPDS
state: Oklahoma
city: Pittsburgh
country: United States
facility: Veterans Research Foundation of Pittsburgh - NAVREF - PPDS
state: Pennsylvania
city: Garland
country: United States
facility: Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
state: Texas
city: Houston
country: United States
facility: Precision Research Institute, LLC
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc.
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: Aztec Medical Research
state: Texas
city: Houston
country: United States
facility: BI Research Center
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute LLC
state: Texas
city: Galax
country: United States
facility: Mid Atlantic Health Specialists
state: Virginia
city: Winchester
country: United States
facility: Winchester Gastroenterology Associates
state: Virginia
city: La Crosse
country: United States
facility: Mayo Clinic Health System - PPDS
state: Wisconsin
city: San Miguel de Tucumán
country: Argentina
facility: Sanatorio 9 de Julio SA
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Fundación Favaloro
city: Córdoba
country: Argentina
facility: Hospital Privado Centro Médico de Córdoba
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
state: Vlaams Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Vlaanderen
city: Mouscron
country: Belgium
facility: CHU Mouscron
city: Banja Luka
country: Bosnia and Herzegovina
facility: Clinical Center Banja Luka
city: Sofia
country: Bulgaria
facility: Second Multiprofile Hospital for Active Treatment Sofia
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Diagnostic and Consulting Center Aleksandrovska EOOD
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveta Anna
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
state: Sofia-Grad
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Eurohospital
city: Ruse
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS
city: Sevlievo
country: Bulgaria
facility: Medical Center-1-Sevlievo EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD - PPDS
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
city: Sofia
country: Bulgaria
facility: Medical Center Convex EOOD
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Centre Mladost - M OOD
city: Victoria
country: Canada
facility: Percuro Clinical Research LTD
state: British Columbia
city: Toronto
country: Canada
facility: Toronto Digestive Disease Associates Inc
state: Ontario
city: Medellin
country: Colombia
facility: Hospital Pablo Tobón Uribe
state: Antioquia
city: Bogota
country: Colombia
facility: Fundación Clínica Shaio
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Servimed S.A.S
state: Santander
city: Cali
country: Colombia
facility: IPS Centro Médico Julián Coronel S.A.S. - PPDS
city: Kohta-Järve
country: Estonia
facility: East Viru Central Hospital
city: Parnu
country: Estonia
facility: OÜ LV Venter
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Athens
country: Greece
facility: Ippokrateio General Hospital of Athens
state: Attiki
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Thessaloniki
country: Greece
facility: Theageneio Anticancer Oncology Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Euromedica - PPDS
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft
city: Budapest
country: Hungary
facility: ENDOMEDIX Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Mohacs
country: Hungary
facility: Mohacsi Korhaz
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa János Kórház
city: Szentes
country: Hungary
facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Veszprém
country: Hungary
facility: Csolnoky Ferenc Korhaz
city: Vác
country: Hungary
facility: Jávorszky Ödön Kórház
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaidô
city: Kobe-shi
country: Japan
facility: Medical Corporation Aoyama Clinic
state: Hyôgo
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine
state: Hyôgo
city: Asahikawa
country: Japan
facility: Kunimoto Hospital
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Matsumoto-shi
country: Japan
facility: Aizawa Hospital
city: Oita
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic
city: Osaka
country: Japan
facility: Chiinkai Dojima General & Gastroenterology Clinic
city: Osaka
country: Japan
facility: Yodogawa Christian Hospital
city: Sakai
country: Japan
facility: Bellland General Hospital
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Sendai
country: Japan
facility: Tohoku Rosai Hospital
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
city: Takatsuki
country: Japan
facility: Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital
city: Tokyo
country: Japan
facility: Nihonbashi Egawa Clinic
city: Tokyo
country: Japan
facility: Koukokukai Ebisu Clinic
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gang'weondo
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggido
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center PPDS
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Beirut
country: Lebanon
facility: Rafik Hariri University Hospital
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Ciudad de Mexico
country: Mexico
facility: Health Pharma Professional Research S.A de C.V.
state: Distrito Federal
city: Cuernavaca
country: Mexico
facility: Clinica de Higado y Gastroenterologia Integral, S.C.
state: Morelos
city: Cuernavaca
country: Mexico
facility: JM Research S.C
state: Morelos
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud
state: Yucatán
city: Aguascalientes
country: Mexico
facility: Centro de Investigación Médica Aguascalientes
city: Cuautitlan Izcalli
country: Mexico
facility: Phylasis Clinicas Research S. de R.L. de C.V.
city: Distrito Federal
country: Mexico
facility: Centro de Investigacion Clinica Acelerada, S.C.
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V.
city: Tlalnepantla De Baz
country: Mexico
facility: Clinical Research Institute
city: Zapopan, Jalisco
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
state: South Island
city: Newtown
country: New Zealand
facility: Wellington Hospital
state: Wellington
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guimarães
country: Portugal
facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Portimão
country: Portugal
facility: Centro Hospitalar do Algarve - Hospital de Portimao
city: Setubal
country: Portugal
facility: Hospital de São Bernardo
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Nitra
country: Slovakia
facility: KM Management, spol. s r.o.
city: Presov
country: Slovakia
facility: Gastro LM, s.r.o.
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
state: Córdoba
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Vigo
country: Spain
facility: CHUVI - H.U. Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Centro Medico Teknon - Grupo Quironsalud
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Zürich
country: Switzerland
facility: Universität Zürich
state: Zürich (de)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
state: Chernivets'ka Oblast
city: Kharkiv
country: Ukraine
facility: Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
state: Kharkivs'ka Oblast
city: Vinnytsia
country: Ukraine
facility: Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
state: Vinnyts'ka Oblast
city: Vinnytsya
country: Ukraine
facility: Municipal Nonprofit Enterprise Vinnytsia City Clinical Hospital #1
state: Vinnyts'ka Oblast
city: Dnipro
country: Ukraine
facility: ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
city: Dnipro
country: Ukraine
facility: LLC Medical Center Family Medicine Clinic
city: Dnipro
country: Ukraine
facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
city: Kharkiv
country: Ukraine
facility: Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine
city: Kharkiv
country: Ukraine
facility: Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
city: Kharkiv
country: Ukraine
facility: MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection
city: Kherson
country: Ukraine
facility: Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
city: Kryvyi Rih
country: Ukraine
facility: Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Clinic Blagomed
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #18
city: Kyiv
country: Ukraine
facility: Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"
city: Kyiv
country: Ukraine
facility: Municipal Institution of KRC Kyiv Regional Hospital #2
city: Kyiv
country: Ukraine
facility: Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
city: Lviv
country: Ukraine
facility: Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
city: Odesa
country: Ukraine
facility: Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
city: Uzhhorod
country: Ukraine
facility: MNPE Central City Clinical Hospital of Uzhhorod City Council
city: Vinnytsia
country: Ukraine
facility: Medical Clinical Research Center of Medical Center LLC Health Clinic
city: Vinnytsia
country: Ukraine
facility: Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
city: Vinnytsia
country: Ukraine
facility: City Clinical Hospital #1
city: Vinnytsia
country: Ukraine
facility: Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"
city: Zaporizhzhia
country: Ukraine
facility: Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council
city: Zaporizhzhia
country: Ukraine
facility: MNPE City Hospital No. 6 of Zaporizhzhia City Council
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: