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Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF‑06700841 In Subjects With Moderate To Severe Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03395184
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Placebo PF-06651600 Drug: Placebo PF-06700841 Drug: PF-06651600 Drug: PF-06700841 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: PF-06700841 or placebo Drug: Placebo PF-06700841
12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.

Drug: PF-06700841
60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks

Experimental: PF-06651600 or placebo Drug: Placebo PF-06651600
12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks

Drug: PF-06651600
200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks




Primary Outcome Measures :
  1. Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Number of participants with potentially clinically important serious infections findings [ Time Frame: 64 weeks ]
  2. Mean change from baseline in SES-CD score at Week 12. [ Time Frame: Baseline, week 12 ]
  3. Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12. [ Time Frame: Baseline, week 12 ]
    Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.

  4. Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12. [ Time Frame: Week 12 ]
    Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.

  5. Proportion of subjects achieving mucosal healing at Week 12. [ Time Frame: Week 12 ]
    Number of subjects achieving mucosal healing at Week 12.

  6. Number of subjects with adverse events [ Time Frame: Baseline up to 64 weeks ]
    Number of participants with reported adverse events

  7. Number of subjects with serious adverse events [ Time Frame: Baseline up to 64 weeks ]
    Number of participants with reported serious adverse events

  8. Number of subjects with electrocardiogram findings of potential clinical importance. [ Time Frame: Baseline up to 64 weeks ]
    Number of participants with potentially clinically important electrocardiogram findings.

  9. Number of subjects withdrawal due to adverse events [ Time Frame: Baseline up to 64 weeks ]
    Number of subjects withdrawal due to adverse events.

  10. Number of subjects with vital signs findings of potential clinical importance. [ Time Frame: Baseline up to 64 weeks ]
    Number of participants with potentially clinically important vital signs findings.

  11. Number of subjects with laboratory tests findings of potential clinical importance. [ Time Frame: Baseline u to 64 weeks ]
    Number of participants with potentially clinically important laboratory findings.

  12. Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively. [ Time Frame: week 64 ]
    Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12

  13. Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12. [ Time Frame: week 64 ]
    Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and/or female subjects 18 years to 75 years of age
  2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.
  3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.
  4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.
  5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:

    •Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).

  6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below:

    • Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.
    • Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.
    • Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.

Exclusion Criteria:

  1. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.
  2. Presence of active (draining) fistulae or intra abdominal or perineal abscesses.
  3. Strictures with obstructive symptoms.
  4. Short bowel syndrome.
  5. History of bowel perforation requiring surgical intervention within the past 12 months.
  6. Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.
  7. History of bowel surgery within 6 months prior to baseline.
  8. Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
  9. Subjects with primary sclerosing cholangitis.
  10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.
  11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.
  12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.
  13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period:

    1. >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.
    2. IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.
    3. Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.
    4. Anti TNF inhibitors (or biosimilars thereof) as described below:

      • Infliximab within 8 weeks prior to baseline;
      • Adalimumab within 8 weeks prior to baseline;
      • Certolizumab within 8 weeks prior to baseline;
    5. Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.
    6. Ustekinumab within 8 weeks prior to baseline.
    7. Interferon therapy within 8 weeks prior to baseline.
    8. Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).
    9. Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.
    10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.
    11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.
    12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.
    13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.
    14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.

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): NCT03395184


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Locations
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United States, Alabama
Dothan Surgery Center Recruiting
Dothan, Alabama, United States, 36301
Gut P.C., dba Digestive Health Specialists of the Southeast Recruiting
Dothan, Alabama, United States, 36305
United States, California
Brighton Surgical Center Recruiting
Beverly Hills, California, United States, 90210
Long Beach Clinical Trial Services, Inc. Recruiting
Long Beach, California, United States, 90806
Entertainment Medical Group Recruiting
Los Angeles, California, United States, 90036
Gastrointestinal Biosciences Clinical Trials, LLC Recruiting
Los Angeles, California, United States, 90067
Alliance Clinical Research, LLC Recruiting
Poway, California, United States, 92064
United States, Colorado
Front Range Endoscopy Center Not yet recruiting
Colorado Springs, Colorado, United States, 80903
United States, Florida
Gastro Florida Recruiting
Clearwater, Florida, United States, 33756-3839
West Coast Endoscopy Center Recruiting
Clearwater, Florida, United States, 33756
Gastro Florida Recruiting
Clearwater, Florida, United States, 33762
University of Miami Clinical Research Building Recruiting
Miami, Florida, United States, 33136
University of Miami Crohn's and Colitis Center Recruiting
Miami, Florida, United States, 33136
University of Miami Hospital and Clinics Recruiting
Miami, Florida, United States, 33136
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Millenia Surgery Center Terminated
Orlando, Florida, United States, 32811
HMD Research LLC Terminated
Orlando, Florida, United States, 32819
United States, Kansas
WestGlen Gastrointestinal Consultants, P.A. Recruiting
Shawnee Mission, Kansas, United States, 66217
United States, Louisiana
CroNOLA, LLC Recruiting
Houma, Louisiana, United States, 70360
Gulf Coast Surgical Center Recruiting
Houma, Louisiana, United States, 70360
The Hearing Center (Audiology) Recruiting
Houma, Louisiana, United States, 70360
United States, Maryland
Chevy Chase Endoscopy Center Recruiting
Chevy Chase, Maryland, United States, 20815
MGG Group Co., Inc., Chevy Chase Clinical Research Recruiting
Chevy Chase, Maryland, United States, 20815
Capitol Research Recruiting
Rockville, Maryland, United States, 20850
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Mass Eye and Ear, Longwood Recruiting
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Caro Health Plaza Recruiting
Caro, Michigan, United States, 48723
Clinical Research Institute of Michigan, LLC Recruiting
Chesterfield, Michigan, United States, 48047
Eastside Endoscopy Center Recruiting
Macomb, Michigan, United States, 48044
Eastside Endoscopy Center Recruiting
Saint Clair Shores, Michigan, United States, 48081
United States, New York
Weill Cornell Medical College (Clinical Site) Recruiting
New York, New York, United States, 10021
New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy) Recruiting
New York, New York, United States, 10065
New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy Recruiting
New York, New York, United States, 10065
Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite) Recruiting
New York, New York, United States, 10065
Weill Cornell Medical College - New York Presbyterian Hospital Recruiting
New York, New York, United States, 10065
DiGiovanna Institute for Medical Education And Research Recruiting
North Massapequa, New York, United States, 11758-1853
United States, North Carolina
UNC Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals Endoscopy Center at Meadowmont Recruiting
Chapel Hill, North Carolina, United States, 27517
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Gastroenterology Associates of the Piedmont, PA Recruiting
Winston-Salem, North Carolina, United States, 27103
PMG Research of Winston-Salem, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Tennessee
Holston Medical Group Terminated
Kingsport, Tennessee, United States, 37660
Holston Valley Surgery Center Terminated
Kingsport, Tennessee, United States, 37660
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212-1375
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212-1610
Vanderbilt University Medical Center - GI Endoscopy Lab Recruiting
Nashville, Tennessee, United States, 37232-5543
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-7610
Vanderbilt University Medical Center - GI Research Regulatory Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Cross Timbers Surgery Center L.P. (Colonoscopy) Recruiting
Arlington, Texas, United States, 76012
Envision Imaging (CXR) Recruiting
Arlington, Texas, United States, 76012
Texas Clinical Research Institiute, LLC Recruiting
Arlington, Texas, United States, 76012
HRMD Research Not yet recruiting
Dallas, Texas, United States, 75240
Hermann Drive Surgical Hospital Recruiting
Houston, Texas, United States, 77004
Pearland Surgery Center Recruiting
Houston, Texas, United States, 77047
Gulf Coast Research Group, LLC Recruiting
Houston, Texas, United States, 77098
Lonestar Endoscopy, LLP Recruiting
Southlake, Texas, United States, 76092
Texas Digestive Disease Consultants Recruiting
Southlake, Texas, United States, 76092
United States, Virginia
Verity Research, Inc. Recruiting
Fairfax, Virginia, United States, 22031
Australia, New South Wales
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Australia, Queensland
Mater Misericordiae Ltd Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Ballarat Base Hospital Recruiting
Ballarat, Victoria, Australia, 3350
Australia, Western Australia
Saint John of God Health Care Inc. Recruiting
Subiaco, Western Australia, Australia, 6008
Austria
AKH Wien Universitaetsklinik fuer Innere Medizin III Not yet recruiting
Wien, Austria, 1090
Belgium
University Hospital Brussels Recruiting
Jette, Belgium, 1090
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
CHC - Saint-Joseph Recruiting
Liege, Belgium, 4000
Bosnia and Herzegovina
Javna zdravstvena ustanova Univerzitetski klinicki centar Republike Srpske, Not yet recruiting
Banja Luka, Bosnia and Herzegovina, 78000
Sveucilisna klinicka bolnica Mostar, Not yet recruiting
Mostar, Bosnia and Herzegovina, 88000
Canada, Manitoba
Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Hôpital Montfort Not yet recruiting
Ottawa, Ontario, Canada, K1K 0T2
Croatia
Klinicki bolnicki centar Sestre milosrdnice Recruiting
Zagreb, Hrvatska, Croatia, 10000
Klinicki bolnicki centar Rijeka, Odjel za gastroenterologiju Not yet recruiting
Rijeka, Croatia, 51000
Klinicki Bolnicki centar Split, Zavod za gastroenterologiju Recruiting
Split, Croatia, 21000
Opca bolnica Zadar, Odjel za gastroenterologiju Recruiting
Zadar, Croatia, 23000
Klinicka bolnica Dubrava Zagreb Recruiting
Zagreb, Croatia, 10000
Klinicki bolnicki centar Zagreb, Zavod za gastroenterologiju i hepatologiju Recruiting
Zagreb, Croatia, 10000
Czechia
Lekarna Altea Not yet recruiting
Bilina, Czechia, 41801
Nemocnice Horovice, a.s. Recruiting
Horovice, Czechia, 268 31
Hepato-Gastroenterologie HK s.r.o. Not yet recruiting
Hradec Kralove, Czechia, 500 12
Medialpharma s.r.o. Not yet recruiting
Hradec Kralove, Czechia, 500 12
Gastroenterologicka ambulance a endoskopie Not yet recruiting
Most, Czechia, 43401
Vseobecna fakultni nemocnice Not yet recruiting
Praha 2, Czechia, 128 08
Všeobecná fakultní nemocnice v Praze Not yet recruiting
Praha 2, Czechia, 128 08
Lekarna Sv. Anna Not yet recruiting
Praha 3, Czechia, 130 00
EGK s.r.o. - Sanatorium sv. Anny Not yet recruiting
Praha 3, Czechia, 13000
Fakultni nemocnice v Motole Not yet recruiting
Praha 5, Czechia, 150 06
Fakultní Nemocnice v Motole Not yet recruiting
Praha 5, Czechia, 150 06
Nemocnice Strakonice, a.s., Interni oddeleni Recruiting
Strakonice, Czechia, 386 01
Nemocnice Strakonice, a.s. Recruiting
Strakonice, Czechia, 386 29
Georgia
The First University Clinic of TSMU Recruiting
Tbilisi, Georgia, 0141
David Tatishvili Medical Center Recruiting
Tbilisi, Georgia, 0186
Germany
Paian MED Research GmbH Recruiting
Berlin, Germany, 10318
Krankenhaus Waldfriede e.V., Recruiting
Berlin, Germany, 14163
Universitaetsklinikum Bonn Not yet recruiting
Bonn, Germany, 53127
Universitaetsklinikum Schleswig-Holstein Not yet recruiting
Kiel, Germany, 24105
Universitätsklinikum Giessen und Marburg GmbH Not yet recruiting
Marburg, Germany, 35043
Hungary
Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz Recruiting
Bekescsaba, Hungary, 5600
Semmelweis Egyetem, II. Belgyogyaszati Klinika Recruiting
Budapest, Hungary, 1088
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak Active, not recruiting
Budapest, Hungary, 1125
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos Laboratorium Recruiting
Gyula, Hungary, 5700
Clinfan Szolgaltato Kft. Recruiting
Szekszard, Hungary, 7100
Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati Osztaly Not yet recruiting
Veszprem, Hungary, 8200
Italy
IRCCS Saverio de Bellis Recruiting
Castellana Grotte, Bari, Italy, 70013
A.O.Spedali Civili Recruiting
Brescia, BS, Italy, 25123
Univ. "Magna Graecia" di Catanzaro Recruiting
Catanzaro, CZ, Italy, 88100
ASST Monza Not yet recruiting
Monza, MB, Italy, 20090
ASST Rhodense - Ospedale di Circolo di Rho Recruiting
Rho, Milano, Italy, 20017
Istituto Clinico Humanitas IRCCS - IBD Center Recruiting
Rozzano, Milan, Italy, 20089
A.O.U. Policlinico G. Martino Recruiting
Messina, Italy, 98125
AOU Policlinico di Modena Recruiting
Modena, Italy, 41124
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Policlinico Universitario Campus Bio-Medico Recruiting
Roma, Italy, 00128
Policlinico Gemelli/Complesso Integrato Columbus Not yet recruiting
Rome, Italy, 00168
Korea, Republic of
Kyungpook National University Hospital Recruiting
Daegu, Korea, Korea, Republic of, 41944
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 02447
Kangbuk Samsung Hospital Not yet recruiting
Seoul, Korea, Republic of, 03181
Severance Hospital, Yonsei University Health System Not yet recruiting
Seoul, Korea, Republic of, 03722
The Catholic University of Korea, Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of, 06591
Lebanon
Hôtel Dieu de France Hospital Not yet recruiting
Achrafieh, Beirut, Lebanon
Saint George Hospital University Medical Center Not yet recruiting
Achrafieh, Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon
Ain Wazein Medical Village Recruiting
El Chouf, Lebanon
Centre Hospitalier Universitaire Notre Dame de Secours Not yet recruiting
Jbeil, Lebanon
Hammoud Hospital University Medical Center Not yet recruiting
Saida, Lebanon
Poland
H-T. Centrum Medyczne-Endoterapia Recruiting
Tychy, Silesia, Poland, 43-100
Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus Recruiting
Katowice, Poland, 40-659
ETG Kielce Recruiting
Kielce, Poland, 25-355
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla Recruiting
Knurow, Poland, 44-190
Szpital w Knurowie Sp. z o.o. Recruiting
Knurow, Poland, 44-190
Centrum Badan Klinicznych JCI Recruiting
Krakow, Poland, 30-348
Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny Recruiting
Krakow, Poland, 30-539
Centrum Medyczne EVITA Recruiting
Krakow, Poland, 31-153
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Recruiting
Krakow, Poland, 31-826
Centrum Medyczne Szpital Swietej Rodziny Sp z o.o. Recruiting
Lodz, Poland, 90-302
Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp z o.o. Recruiting
Lodz, Poland, 90-302
Medical Magnus Clinic Not yet recruiting
Lodz, Poland, 90-552
Wojewodzki Szpital Specjalistyczny im. Bieganskiego w Lodzi Not yet recruiting
Lodz, Poland, 91-347
Gastromed Sp. z o.o. Recruiting
Lublin, Poland, 20-582
Ai Centrum Medyczne Sp. Z O.O. Sp.K. Recruiting
Poznan, Poland, 61-113
Korczowski Bartosz Gabinet Lekarski Not yet recruiting
Rzeszow, Poland, 35-302
ENDOSKOPIA Sp. z o. o. Recruiting
Sopot, Poland, 81-756
Szpital Sredzki Serca Jezusowego sp. z o.o. Recruiting
Sroda Wielkopolska, Poland, 63-000
EZ-MED Sp. z o.o. Sp.k. Recruiting
Swidnica, Poland, 58-100
Pracownia Endoskopii Szpital MSW Recruiting
Szczecin, Poland, 70-001
Twoja Przychodnia Szczecinskie Centrum Medyczne Recruiting
Szczecin, Poland, 71-434
Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Recruiting
Torun, Poland, 87-100
Centrum Zdrowia MDM Recruiting
Warszawa, Poland, 00-635
Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o. Recruiting
Wloclawek, Poland, 87-800
Melita Medical Sp. z o.o. Recruiting
Wroclaw, Poland, 50-449
Centrum Gastrologiczno Hepatologiczne Recruiting
Wroclaw, Poland, 50-555
Planetmed sp. z.o.o. Not yet recruiting
Wroclaw, Poland, 52-210
Lexmedica Recruiting
Wroclaw, Poland, 53-114
Russian Federation
SPb SBIH "City Hospital #40 of the Kurortnyi region" Recruiting
Saint-Petersburg, Sestroretsk, Russian Federation, 197706
LLC "Alliance Biomedical-Ural Group" Recruiting
Izhevsk, Russian Federation, 426061
Clinic of FSBEI HE KSMU MoH RF Not yet recruiting
Krasnodar, Russian Federation, 350072
LLC "Olla-Med" Recruiting
Moscow, Russian Federation, 105554
Sechenov University on the base of Institute of Translational Medicine and Biotechnology Recruiting
Moscow, Russian Federation, 119435
Limited Liability Company "Medical Center SibNovoMed" Recruiting
Novosibirsk, Russian Federation, 630005
Federal State Budgetary Scientific Institution "Scientific Research Institute of Physiology and Recruiting
Novosibirsk, Russian Federation, 630117
Clinic at FSBEI HE "Omsk State Medical University" MoH RF Recruiting
Omsk, Russian Federation, 644050
LLC "New Clinic" Recruiting
Pyatigorsk, Russian Federation, 357500
Limited Liability Company "RIAT" Recruiting
Saint-Petersburg, Russian Federation, 195220
Saint-Petersburg State Budgetary Healthcare Institution "City Hospital #26" Recruiting
Saint-Petersburg, Russian Federation, 196247
Private Institution Educational Organization of Higher Education Recruiting
Samara, Russian Federation, 443011
Non-state Healthcare Institution 'Railway Clinical Hospital at Samara Station of Open Joint Stock Recruiting
Samara, Russian Federation, 443029
Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Hospital of the Righteous Recruiting
St. Petersburg, Russian Federation, 197706
Saudi Arabia
King AbdulAziz Medical City Not yet recruiting
Riyadh, Saudi Arabia, 11426
King Khalid University Hospital Not yet recruiting
Riyadh, Saudi Arabia, 11472
Serbia
Klinicko Bolnicki Centar "Bezanijska Kosa" Recruiting
Zemun, Beograd, Serbia, 11080
Klinicki Centar Srbije, Klinika za gastroenterohepatologiju Not yet recruiting
Beograd, Srbija, Serbia, 11000
Klinicki Centar Kragujevac Recruiting
Kragujevac, Srbija, Serbia, 34000
Klinicki Centar Nis Not yet recruiting
Nis, Srbija, Serbia, 18000
Opsta bolnica Subotica Recruiting
Subotica, Srbija, Serbia, 24000
Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija Recruiting
Zrenjanin, Srbija, Serbia, 23000
Klinicko Bolnicki Centar Zvezdara, Klinika za Interne bolesti, Not yet recruiting
Beograd, Serbia, 11000
Klinicko Bolnicki Centar Zemun, klinika za Internu medicinu, Not yet recruiting
Zemun, Beograd, Serbia, 11080
Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica Not yet recruiting
Banska Bystrica, Slovakia, 975 17
Breznianske centrum gastroenterologie s.r.o. Not yet recruiting
Brezno, Slovakia, 97701
KM Management spol. s.r.o. Not yet recruiting
Nitra, Slovakia, 949 01
Accout Center s.r.o. Gastroenterologicka ambulancia Not yet recruiting
Sahy, Slovakia, 936 01
ENDOMED, s.r.o. Recruiting
Vranov nad Toplou, Slovakia, 093 01
South Africa
Lenasia Clinical Trial Centre Not yet recruiting
Lenasia, Gauteng, South Africa, 1827
Wits Clinical Research Trial Site Not yet recruiting
Parktown, Gauteng, South Africa, 2193
Wits Clinical Reasearch - Wits Bara Clinical Trial Site Not yet recruiting
Soweto, Gauteng, South Africa, 2013
Dr Wright Private Practice Not yet recruiting
Claremont, Western CAPE, South Africa, 7708
Spain
Hospital Universitario Marques de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Hospital Universitari i Politecnic La Fe Recruiting
Valencia, Spain, 46026
Switzerland
Verein IBD Study Group Not yet recruiting
Bern, Switzerland, CH - 3012
Universitätsspital Zürich Not yet recruiting
Zürich, Switzerland, CH-8091
Tunisia
La Rabta Hospital Not yet recruiting
Tunis, Tunisia, 1007
Habib Thameur Hospital Recruiting
Tunis, Tunisia, 1008
Turkey
Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi, Ic Hastaliklari Anabilim Dali, Not yet recruiting
Ankara, Turkey, 06100
Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi Not yet recruiting
Ankara, Turkey, 06100
Hacettepe Universitesi Tip Fakultesi Recruiting
Ankara, Turkey, 06230
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi Recruiting
Istanbul, Turkey, 34093
Istanbul Universitesi Cerrahpasa Tip Facultesi Not yet recruiting
Istanbul, Turkey, 34098
Istanbul Universitesi Cerrahpasa Tip Fakultesi Not yet recruiting
Istanbul, Turkey, 34098
Erciyes Universitesi Tip Fakultesi Recruiting
Kayseri, Turkey, 38039
Kocaeli Universitesi Tip Fakultesi Not yet recruiting
Kocaeli, Turkey, 41380
Mersin Universitesi Tip Fakultesi Hastanesi, Ic Hastaliklari Recruiting
Mersin, Turkey, 33110
Mersin Universitesi Tip Fakultesi Hastanesi Recruiting
Mersin, Turkey, 33110
Karadeniz Teknik Universitesi Tip Fakultesi, Ic Hastaliklari Recruiting
Trabzon, Turkey, 61080
Karadeniz Teknik Universitesi Tip Fakultesi Recruiting
Trabzon, Turkey, 61080
Bulent Ecevit Universitesi Tip Fakultesi Recruiting
Zonguldak, Turkey, 67600
Ukraine
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", gastroenterology department, Recruiting
Chernivtsi, Ukraine, 58001
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgery Department Not yet recruiting
Chernivtsi, Ukraine, 58001
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 n.a. prof. O.O. Shalimov Not yet recruiting
Kharkiv, Ukraine, 61037
Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center Not yet recruiting
Kropyvnytskyi, Ukraine, 25006
Kyiv Municipal Clinical Hospital #18, Proctology Department Recruiting
Kyiv, Ukraine, 01030
Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center Recruiting
Kyiv, Ukraine, 03680
Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway Recruiting
Lviv, Ukraine, 79007
Vinnytsia City Clinical Hospital No.1 Recruiting
Vinnytsia, Ukraine, 21000
Private Small-Scale Enterprise Medical Center "Pulse" Recruiting
Vinnytsia, Ukraine, 21001
Vinnytsia Regional Clinical Hospital for War Veterans Recruiting
Vinnytsia, Ukraine, 21005
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov Recruiting
Vinnytsia, Ukraine, 21018
United Arab Emirates
Al Baraha Hospital - MOH Not yet recruiting
Dubai, United Arab Emirates, 22241
Emirates Specialty Hospital Not yet recruiting
Dubai, United Arab Emirates, PO BOX 505240
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03395184     History of Changes
Other Study ID Numbers: B7981007
2017-003359-43 ( EudraCT Number )
PIZZICATO ( Other Identifier: Alias Study Number )
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases