Clinical trial NCT03395184: Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-01-10
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

        14) Subjects with history of thrombotic event(s), including deep venous thrombosis (DVT), and known inherited conditions that predispose to hypercoagulability.

Primary outcomes:
measure: Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period
timeFrame: Week 12
measure: Number of Participants With Laboratory Test Abnormalities During OLE Period
timeFrame: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
measure: Number of Participants According to Categorization of Vital Signs During OLE Period
timeFrame: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
measure: Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During OLE Period
timeFrame: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) During OLE Period
timeFrame: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
measure: Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During OLE Period
timeFrame: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
measure: Number of Participants With Discontinuations Due to Adverse Events During OLE Period
timeFrame: From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Secondary outcomes:
measure: Number of Participants With Laboratory Test Abnormalities During Induction Period
timeFrame: From start of study intervention on Day 1 up to Week 12
measure: Number of Participants According to Categorization of Vital Signs During Induction Period
timeFrame: From start of study intervention on Day 1 up to Week 12
measure: Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During Induction Period
timeFrame: From start of study intervention on Day 1 up to Week 12
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) During Induction Period
timeFrame: From start of study intervention on Day 1 up to Week 12
measure: Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During Induction Period
timeFrame: From start of study intervention on Day 1 up to Week 12
measure: Number of Participants Discontinuation Due to Adverse Events During Induction Period
timeFrame: From start of study intervention on Day 1 up to Week 12
measure: Number of Participants With Serious Infections During Induction Period
timeFrame: From start of study intervention on Day 1 up to Week 12
measure: Percentage of Participants Who Achieved Clinically Meaningful Endoscopic Improvement (CMEI) (Reduction of >=3 Points From Baseline in SES-CD Score) at Week 12: Induction Period
timeFrame: Week 12
measure: Mean Change From Baseline in SES-CD Score at Week 12: Induction Period
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving >=25% Reduction in SES-CD From Baseline (SES-CD 25) at Week 12: Induction Period
timeFrame: Week 12
measure: Percentage of Participants Achieving Endoscopic Remission (SES-CD Score of <= 2) at Week 12: Induction Period
timeFrame: Week 12
measure: Percentage of Participants Achieving Mucosal Healing at Week 12: Induction Period
timeFrame: Week 12
measure: Percentage of Participants Achieving CMEI at Week 64 Among Participants Who Achieved CMEI Response at Week 12 (Baseline of OLE Period): OLE Period
timeFrame: Week 64 (Week 52 of OLE period)
measure: Percentage of Participants Achieving SES CD 25 and SES CD 50 at Week 64 Among Participants Who Achieved SES CD 25 and SES CD 50 at Week 12 (Baseline of OLE Period): OLE Period
timeFrame: Week 64 (Week 52 of OLE period)
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Dothan Surgery Center
state: Alabama
city: Dothan
country: United States
facility: Gut P.C., dba Digestive Health Specialists of the Southeast
state: Alabama
city: Beverly Hills
country: United States
facility: Brighton Surgical Center
state: California
city: Los Angeles
country: United States
facility: Entertainment Medical Group
state: California
city: Los Angeles
country: United States
facility: Gastrointestinal Biosciences Clinical Trials, LLC
state: California
city: Redwood City
country: United States
facility: Stanford Medicine Outpatient Center - Digestive Health Center
state: California
city: Colorado Springs
country: United States
facility: Front Range Endoscopy Center
state: Colorado
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Clearwater
country: United States
facility: West Coast Endoscopy Center
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville - Gastroenterology Emerson
state: Florida
city: Orlando
country: United States
facility: Millenia Surgery Center
state: Florida
city: Orlando
country: United States
facility: HMD Research LLC
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Shawnee Mission
country: United States
facility: WestGlen Gastrointestinal Consultants, P.A.
state: Kansas
city: Chevy Chase
country: United States
facility: Chevy Chase Endoscopy Center
state: Maryland
city: Chevy Chase
country: United States
facility: MGG Group Co., Inc., Chevy Chase Clinical Research
state: Maryland
city: Rockville
country: United States
facility: Capitol Research
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Mass Eye and Ear, Longwood
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Macomb
country: United States
facility: Eastside Endoscopy Center
state: Michigan
city: New York
country: United States
facility: Weill Cornell Medical College - New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - New York Presbyterian Hospital
state: New York
city: North Massapequa
country: United States
facility: DiGiovanna Institute for Medical Education And Research
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals Endoscopy Center at Meadowmont
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Hillsborough
country: United States
facility: UNC GI Procedures Hillsborough
state: North Carolina
city: Winston-Salem
country: United States
facility: Gastroenterology Associates of the Piedmont, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Kingsport
country: United States
facility: Holston Valley Surgery Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt GI Endoscopy Lab at One Hundred Oaks
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Inflammatory Bowel Disease Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Inflammatory Bowel Disease Clinic
state: Tennessee
city: Bellaire
country: United States
facility: First Street Hospital
state: Texas
city: Bellaire
country: United States
facility: First Street Surgical Center
state: Texas
city: Houston
country: United States
facility: Hermann Drive Surgical Hospital
state: Texas
city: Houston
country: United States
facility: Pearland Surgery Center
state: Texas
city: Southlake
country: United States
facility: GI Alliance
state: Texas
city: Southlake
country: United States
facility: Lonestar Endoscopy, LLP
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants (Administrative, Regulatory)
state: Texas
city: Fairfax
country: United States
facility: Gastroenterology Associates of Northern VA
state: Virginia
city: Fairfax
country: United States
facility: Gastroenterology Associates of Northern Virginia
state: Virginia
city: Fairfax
country: United States
facility: Verity Research, Inc.
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd
state: Queensland
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: Subiaco
country: Australia
facility: Saint John of God Health Care Inc.
state: Western Australia
city: Wien
country: Austria
facility: AKH Wien Universitaetsklinik fuer Innere Medizin III
city: Jette
country: Belgium
facility: University Hospital Brussels
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Liége
country: Belgium
facility: CHC MontLégia
city: Banja Luka
country: Bosnia and Herzegovina
facility: Javna zdravstvena ustanova Univerzitetski klinicki centar Republike Srpske,
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg
state: Manitoba
city: Split
country: Croatia
facility: Klinicki Bolnicki centar Split, Zavod za gastroenterologiju
city: Zagreb
country: Croatia
facility: Klinicka bolnica Dubrava Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb, Zavod za gastroenterologiju i hepatologiju
city: Horovice
country: Czechia
facility: Nemocnice Horovice, a.s.
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK s.r.o.
city: Hradec Kralove
country: Czechia
facility: Medialpharma s.r.o.
city: Olomouc
country: Czechia
facility: MUDr. GREGAR s.r.o.
city: Strakonice
country: Czechia
facility: Nemocnice Strakonice, a.s., Interni oddeleni
city: Strakonice
country: Czechia
facility: Nemocnice Strakonice, a.s.
city: Tbilisi
country: Georgia
facility: LTD "Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine"
city: Tbilisi
country: Georgia
facility: The First University Clinic of TSMU
city: Tbilisi
country: Georgia
facility: Institute of Clinical Cardiology, Ltd.
city: Berlin
country: Germany
facility: Paian MED Research GmbH
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e.V.,
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, II. Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
city: Szekszard
country: Hungary
facility: Clinfan Szolgaltato Kft.
city: Castellana Grotte
country: Italy
facility: IRCCS Saverio de Bellis
state: Bari
city: Brescia
country: Italy
facility: A.O.Spedali Civili
state: BS
city: Catanzaro
country: Italy
facility: Univ. "Magna Graecia" di Catanzaro
state: CZ
city: Monza
country: Italy
facility: ASST Monza
state: MB
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas IRCCS - Sez. Autonoma di Malattie, Infiammatorie Croniche Intestinali
state: Milan
city: Messina
country: Italy
facility: A.O.U. Policlinico G. Martino
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Achrafieh
country: Lebanon
facility: Saint George Hospital University Medical Center
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: El Chouf
country: Lebanon
facility: Ain Wazein Medical Village
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Strzegom
country: Poland
facility: STRZEGOMSKIE CENTRUM MEDYCZNO-DIAGNOSTYCZNE Sp. z o.o.
state: Dolnoslaskie
city: Swidnica
country: Poland
facility: DC-MED Sp. z o.o. Sp.k.
state: Other
city: Tychy
country: Poland
facility: H-T. Centrum Medyczne-Endoterapia
state: Silesia
city: Katowice
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus
city: Kielce
country: Poland
facility: ETG Kielce
city: Knurow
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
city: Knurow
country: Poland
facility: Szpital w Knurowie Sp. z o.o.
city: Koscian
country: Poland
facility: Samodzielny Publiczny Zespół Opieki Zdrowotnej, Pracownia Endoskopii
city: Lodz
country: Poland
facility: Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.
city: Lodz
country: Poland
facility: Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.
city: Lodz
country: Poland
facility: Ośrodek Badań Klinicznych Appletreeclinics
city: Lodz
country: Poland
facility: SALVE
city: Lublin
country: Poland
facility: Gastromed Sp. z o.o.
city: Piotrkow Trybunalski
country: Poland
facility: IRMED
city: Piotrkow Tryunalski
country: Poland
facility: Samodzielny Szpital Wojewodzki im. M. Kopernika w Piotrkowie Trybunalskim
city: Poznan
country: Poland
facility: PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia
city: Poznan
country: Poland
facility: Ai Centrum Medyczne Sp. Z O.O. Sp.K.
city: Poznan
country: Poland
facility: AM-MEDIC SP. z o.o.
city: Poznan
country: Poland
facility: Gabinety Lekarskie Rivermed
city: Poznan
country: Poland
facility: PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia
city: Pulawy
country: Poland
facility: KO-MED Centra Kliniczne
city: Pulawy
country: Poland
facility: Zaklad Opieki Zdrowotnej Medical Sp. z o.o., (endoscopy)
city: Sopot
country: Poland
facility: ENDOSKOPIA Sp. z o. o.
city: Sroda Wielkopolska
country: Poland
facility: Szpital Sredzki Serca Jezusowego sp. z o.o.
city: Staszow
country: Poland
facility: Nowe Zdrowie-CK, Kiełtucki i Wspólnicy Sp.j.
city: Szczecin
country: Poland
facility: Twoja Przychodnia Szczecinskie Centrum Medyczne
city: Szczecin
country: Poland
facility: SONOMED
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Endoterapia PFG Sp. z o.o.
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.
city: Wroclaw
country: Poland
facility: Futuremeds
city: Wroclaw
country: Poland
facility: Melita Medical Sp. z o.o.
city: Wroclaw
country: Poland
facility: Centrum Gastrologiczno Hepatologiczne
city: Wroclaw
country: Poland
facility: Lexmedica
city: Wroclaw
country: Poland
facility: Golden Care
city: Pushkin
country: Russian Federation
facility: Private Medical Institution "Euromedservice"
state: Saint-petersburg
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH "City Hospital #40 of the Kurortnyi region"
state: Sestroretsk
city: Pyatigorsk
country: Russian Federation
facility: Polyclinic Ultrasound 4D LLC
state: Stavropol Region
city: Izhevsk
country: Russian Federation
facility: LLC "Alliance Biomedical-Ural Group"
state: Udmurt Republic
city: Izhevsk
country: Russian Federation
facility: LLC "Alliance Biomedical-Ural Group"
city: Moscow
country: Russian Federation
facility: LLC "Olla-Med"
city: Moscow
country: Russian Federation
facility: Sechenov University on the base of Institute of Translational Medicine and Biotechnology
city: Novosibirsk
country: Russian Federation
facility: Limited Liability Company "Medical Center SibNovoMed"
city: Novosibirsk
country: Russian Federation
facility: Novosibirskiy Gastrocenter
city: Omsk
country: Russian Federation
facility: Clinic at FSBEI HE "Omsk State Medical University" MoH RF
city: Pyatigorsk
country: Russian Federation
facility: LLC "New Clinic"
city: Saint Petersburg
country: Russian Federation
facility: LLC "Research center Eco-Safety"
city: Saint-Petersburg
country: Russian Federation
facility: Limited Liability Company "Medical Center "Reavita Med SPb" (OOO "MC "RM SPb")
city: Saint-Petersburg
country: Russian Federation
facility: Limited Liability Company "RIAT"
city: Saint-Petersburg
country: Russian Federation
facility: Limited Liability Company "RIAT SPb"
city: Samara
country: Russian Federation
facility: Private Institution Educational Organization of Higher Education
city: Samara
country: Russian Federation
facility: Non-state Healthcare Institution 'Railway Clinical Hospital at Samara Station of Open Joint Stock
city: Samara
country: Russian Federation
facility: Limited Liability Company Medical Company "Hepatolog"
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Hospital of the Righteous
city: Stavropol
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Stavropol Region
city: Riyadh
country: Saudi Arabia
facility: King AbdulAziz Medical City
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospital
city: Zemun
country: Serbia
facility: Klinicko Bolnicki Centar "Bezanijska Kosa"
state: Beograd
city: Kragujevac
country: Serbia
facility: Klinicki Centar Kragujevac
state: Srbija
city: Subotica
country: Serbia
facility: Opsta bolnica Subotica
state: Srbija
city: Zrenjanin
country: Serbia
facility: Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija
state: Srbija
city: Beograd
country: Serbia
facility: KBC "Dr Dragisa Misovic-Dedinje"
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
city: Vranov nad Toplou
country: Slovakia
facility: ENDOMED, s.r.o.
city: Parktown
country: South Africa
facility: Wits Clinical Research Trial Site
state: Gauteng
city: Claremont
country: South Africa
facility: Dr Wright Private Practice
state: Western CAPE
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Tunis
country: Tunisia
facility: La Rabta Hospital
city: Tunis
country: Tunisia
facility: Habib Thameur Hospital
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi, Ic Hastaliklari
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi
city: Zonguldak
country: Turkey
facility: Bulent Ecevit Universitesi Tip Fakultesi
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital", Surgery Department
city: Kharkiv
country: Ukraine
facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 n.a. prof. O.O. Shalimov
city: Kyiv
country: Ukraine
facility: Medical Centre Medical Clinic Blagomed LLC
city: Kyiv
country: Ukraine
facility: Medical Center "OK Clinic+" of International Institute of Clinical Trials
city: Kyiv
country: Ukraine
facility: Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center
city: Kyiv
country: Ukraine
facility: Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"
city: Kyiv
country: Ukraine
facility: Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"
city: Lviv
country: Ukraine
facility: Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway
city: Vinnytsia
country: Ukraine
facility: Vinnytsia City Clinical Hospital No.1
city: Vinnytsia
country: Ukraine
facility: Private Small-Scale Enterprise Medical Center "Pulse"
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital for War Veterans
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
city: Zaporizhzhia
country: Ukraine
facility: Medical Center "DIACENTER"LLC
city: Dubai
country: United Arab Emirates
facility: Emirates Specialty Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.