Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
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
3 other identifiers
interventional
244
24 countries
189
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2018
Longer than P75 for phase_2
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2017
CompletedFirst Posted
Study publicly available on registry
January 10, 2018
CompletedStudy Start
First participant enrolled
February 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2023
CompletedResults Posted
Study results publicly available
October 30, 2024
CompletedOctober 30, 2024
October 1, 2024
5.7 years
December 5, 2017
October 7, 2024
October 7, 2024
Conditions
Outcome Measures
Primary Outcomes (7)
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
SES CD50 was defined as 50% improvement from baseline in SES-CD. Baseline was defined as last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right colon(C), transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter\[cm\]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(\>2 cm); ulcerated surface score: 0=none, 1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease.
Week 12
Number of Participants With Laboratory Test Abnormalities During OLE Period
Pre-specified criteria for lab abnormalities included- hematology: hemoglobin(Hb), erythrocytes (ery),hematocrit:\<0.8\*lower limit of normal(LLN);reticulocytes: \<0.5\*LLN, \>1.5\*upper limit of normal(ULN); ery mean corpuscular(EMC) volume: \<0.9\*ULN, \>1.11\*ULN;EMC Hb: \<0.9\*LLN; platelets:\>1.75\*ULN; leukocytes(10\^9/L): \<0.6\*LLN,\>1.5\*ULN;lymphocyte,neutrophil(10\^9/L):\<0.8\*LLN,\>1.2\*ULN;basophil,eosinophil,monocyte(10\^9/L):\>1.2\*ULN;activated partial thromboplastin time (sec): \>1.1\*ULN. Chemistry: bilirubin(mg/dL),aspartate aminotransferase(AT),alanine AT(units per litre)\>3.0\*ULN; protein, albumin(g/dL):\<0.8\*LLN; creatinine, triglycerides (mg/dL):\>1.3\*ULN; urate(mg/dL):\>1.2\*ULN, potassium (mEq/L):\<0.9\*LLN; calcium (mg/dL): \<0.9\*LLN,\>1.1\*ULN. Urinalysis: pH\>8;urine,glucose,protein(mg/dl); ketones, nitrite, urine Hb(scalar):\>=1. Number of participants with any lab abnormality meeting pre-specified criteria are reported.
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Number of Participants According to Categorization of Vital Signs During OLE Period
Vital signs including blood pressure (diastolic blood pressure \[DBP\], systolic blood pressure \[SBP\], and pulse rate \[PR\]) were measured in a supine position using automated devices. DBP included value \< 50 (millimeter of mercury \[mmHg\]), change \>=20 (mmHg) increase and change \>=20 (mmHg) decrease; SBP: value \< 90 (mmHg), change \>= 30 (mmHg) increase and change \>= 30 (mmHg) decrease; PR: value \> 120 (beats per minute \[bpm\]).
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During OLE Period
Single twelve lead ECGs were obtained using an automated ECG machine after participant had rested quietly for at least 10 minutes in a supine position. QTc prolongations were defined as a QTc \>=480 milli second (msec) or an absolute change in QTc greater than (\>) 60 msec. Clinically significant ECG findings were determined by the investigator.
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During OLE Period
An adverse event (AE) was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. An AE was considered TEAE to a given treatment if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period.
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During OLE Period
A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event. An SAE was considered as TESAE if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period.
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Number of Participants With Discontinuations Due to Adverse Events During OLE Period
An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. Discontinuations from study due to TEAEs were defined as participants with an AE record indicating the AE caused permanent discontinuation from the study but action taken with study treatment was not drug withdrawn. Permanent discontinuations from any study intervention due to TEAEs were defined as participants with an AE record indicating that action taken with study treatment was drug withdrawn. In this outcome measure number of participants with discontinuation from study due to AEs and permanent discontinuation from study intervention due to AEs are reported.
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Secondary Outcomes (14)
Number of Participants With Laboratory Test Abnormalities During Induction Period
From start of study intervention on Day 1 up to Week 12
Number of Participants According to Categorization of Vital Signs During Induction Period
From start of study intervention on Day 1 up to Week 12
Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During Induction Period
From start of study intervention on Day 1 up to Week 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During Induction Period
From start of study intervention on Day 1 up to Week 12
Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During Induction Period
From start of study intervention on Day 1 up to Week 12
- +9 more secondary outcomes
Study Arms (2)
PF-06700841 or placebo
EXPERIMENTALPF-06651600 or placebo
EXPERIMENTALInterventions
12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks
12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks
Eligibility Criteria
You may qualify if:
- Male and/or female subjects 18 years to 75 years of age
- Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.
- 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.
- 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.
- 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).
- 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.
You may not qualify if:
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.
- Presence of active (draining) fistulae or intra abdominal or perineal abscesses.
- Strictures with obstructive symptoms.
- Short bowel syndrome.
- History of bowel perforation requiring surgical intervention within the past 12 months.
- 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.
- History of bowel surgery within 6 months prior to baseline.
- Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
- Subjects with primary sclerosing cholangitis.
- Subjects with evidence of colonic adenomas, dysplasia or neoplasia.
- Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.
- 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.
- Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period:
- \>9 mg/day of oral budesonide or \>25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.
- IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (195)
Dothan Surgery Center
Dothan, Alabama, 36301, United States
Gut P.C., dba Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
Brighton Surgical Center
Beverly Hills, California, 90210, United States
Entertainment Medical Group
Los Angeles, California, 90036, United States
Gastrointestinal Biosciences Clinical Trials, LLC
Los Angeles, California, 90067, United States
Stanford Medicine Outpatient Center - Digestive Health Center
Redwood City, California, 94063, United States
Front Range Endoscopy Center
Colorado Springs, Colorado, 80903, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Gastro Florida
Clearwater, Florida, 33756-3839, United States
Gastro Florida
Clearwater, Florida, 33756, United States
West Coast Endoscopy Center
Clearwater, Florida, 33756, United States
Gastro Florida
Clearwater, Florida, 33762, United States
UF Health Jacksonville - Gastroenterology Emerson
Jacksonville, Florida, 32207, United States
Millenia Surgery Center
Orlando, Florida, 32811, United States
HMD Research LLC
Orlando, Florida, 32819, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
WestGlen Gastrointestinal Consultants, P.A.
Shawnee Mission, Kansas, 66217, United States
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, 20815, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Capitol Research
Rockville, Maryland, 20850, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Mass Eye and Ear, Longwood
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Eastside Endoscopy Center
Macomb, Michigan, 48044, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10021, United States
Weill Cornell Medical College
New York, New York, 10021, United States
New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)
New York, New York, 10065, United States
New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
New York, New York, 10065, United States
Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)
New York, New York, 10065, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10065, United States
DiGiovanna Institute for Medical Education And Research
North Massapequa, New York, 11758-1853, United States
UNC Hospitals
Chapel Hill, North Carolina, 27514, United States
UNC Hospitals Endoscopy Center at Meadowmont
Chapel Hill, North Carolina, 27517, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
UNC GI Procedures Hillsborough
Hillsborough, North Carolina, 27278, United States
Gastroenterology Associates of the Piedmont, PA
Winston-Salem, North Carolina, 27103, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Holston Valley Surgery Center
Kingsport, Tennessee, 37660, United States
Vanderbilt GI Endoscopy Lab at One Hundred Oaks
Nashville, Tennessee, 37204, United States
Vanderbilt Inflammatory Bowel Disease Clinic
Nashville, Tennessee, 37204, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1375, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1610, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5543, United States
Vanderbilt Inflammatory Bowel Disease Clinic
Nashville, Tennessee, 37232, United States
First Street Hospital
Bellaire, Texas, 77401, United States
First Street Surgical Center
Bellaire, Texas, 77401, United States
Hermann Drive Surgical Hospital
Houston, Texas, 77004, United States
Pearland Surgery Center
Houston, Texas, 77047, United States
GI Alliance
Southlake, Texas, 76092, United States
Lonestar Endoscopy, LLP
Southlake, Texas, 76092, United States
Texas Digestive Disease Consultants (Administrative, Regulatory)
Southlake, Texas, 76092, United States
Gastroenterology Associates of Northern VA
Fairfax, Virginia, 22031, United States
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, 22031, United States
Verity Research, Inc.
Fairfax, Virginia, 22031, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, 4101, Australia
Ballarat Base Hospital
Ballarat, Victoria, 3350, Australia
Saint John of God Health Care Inc.
Subiaco, Western Australia, 6008, Australia
AKH Wien Universitaetsklinik fuer Innere Medizin III
Vienna, 1090, Austria
University Hospital Brussels
Jette, 1090, Belgium
University Hospitals Leuven
Leuven, 3000, Belgium
CHC MontLégia
Liége, 4000, Belgium
Javna zdravstvena ustanova Univerzitetski klinicki centar Republike Srpske,
Banja Luka, 78000, Bosnia and Herzegovina
Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg
Winnipeg, Manitoba, R3A 1R9, Canada
Klinicki Bolnicki centar Split, Zavod za gastroenterologiju
Split, 21000, Croatia
Klinicka bolnica Dubrava Zagreb
Zagreb, 10000, Croatia
Klinicki bolnicki centar Zagreb, Zavod za gastroenterologiju i hepatologiju
Zagreb, 10000, Croatia
Nemocnice Horovice, a.s.
Hořovice, 268 31, Czechia
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, 500 12, Czechia
Medialpharma s.r.o.
Hradec Králové, 500 12, Czechia
MUDr. GREGAR s.r.o.
Olomouc, 77900, Czechia
Nemocnice Strakonice, a.s., Interni oddeleni
Strakonice, 386 01, Czechia
Nemocnice Strakonice, a.s.
Strakonice, 386 29, Czechia
LTD "Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine"
Tbilisi, 0112, Georgia
The First University Clinic of TSMU
Tbilisi, 0141, Georgia
Institute of Clinical Cardiology, Ltd.
Tbilisi, 0159, Georgia
Paian MED Research GmbH
Berlin, 10318, Germany
Krankenhaus Waldfriede e.V.,
Berlin, 14163, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz
Békéscsaba, 5600, Hungary
Semmelweis Egyetem, II. Belgyogyaszati Klinika
Budapest, 1088, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, 1125, Hungary
Clinfan Szolgaltato Kft.
Szekszárd, 7100, Hungary
IRCCS Saverio de Bellis
Castellana Grotte, BARI, 70013, Italy
A.O.Spedali Civili
Brescia, BS, 25123, Italy
Univ. "Magna Graecia" di Catanzaro
Catanzaro, CZ, 88100, Italy
ASST Monza
Monza, MB, 20090, Italy
Istituto Clinico Humanitas IRCCS - Sez. Autonoma di Malattie, Infiammatorie Croniche Intestinali
Rozzano, Milan, 20089, Italy
A.O.U. Policlinico G. Martino
Messina, 98125, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Policlinico Universitario Campus Bio-Medico
Roma, 00128, Italy
American University of Beirut Medical Center
Beirut, Lebanon
Saint George Hospital University Medical Center
El Achrafiyé, Lebanon
Ain Wazein Medical Village
El Chouf, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
STRZEGOMSKIE CENTRUM MEDYCZNO-DIAGNOSTYCZNE Sp. z o.o.
Strzegom, Lower Silesian Voivodeship, 58-150, Poland
DC-MED Sp. z o.o. Sp.k.
Swidnica, Other, 58-100, Poland
H-T. Centrum Medyczne-Endoterapia
Tychy, Silesian Voivodeship, 43-100, Poland
Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus
Katowice, 40-659, Poland
ETG Kielce
Kielce, 25-355, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, 44-190, Poland
Szpital w Knurowie Sp. z o.o.
Knurów, 44-190, Poland
Samodzielny Publiczny Zespół Opieki Zdrowotnej, Pracownia Endoskopii
Kościan, 64-000, Poland
Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.
Lodz, 90-302, Poland
Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.
Lodz, 90-302, Poland
Ośrodek Badań Klinicznych Appletreeclinics
Lodz, 90-349, Poland
SALVE
Lodz, 92-551, Poland
Gastromed Sp. z o.o.
Lublin, 20-582, Poland
IRMED
Piotrkow Trybunalski, 97-300, Poland
Samodzielny Szpital Wojewodzki im. M. Kopernika w Piotrkowie Trybunalskim
Piotrkow Tryunalski, 91-300, Poland
PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia
Poznan, 60-848, Poland
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
Poznan, 61-113, Poland
AM-MEDIC SP. z o.o.
Poznan, 61-315, Poland
Gabinety Lekarskie Rivermed
Poznan, 61-441, Poland
PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia
Poznan, 61-731, Poland
KO-MED Centra Kliniczne
Puławy, 24-100, Poland
Zaklad Opieki Zdrowotnej Medical Sp. z o.o., (endoscopy)
Puławy, 24-110, Poland
ENDOSKOPIA Sp. z o. o.
Sopot, 81-756, Poland
Nowe Zdrowie-CK, Kiełtucki i Wspólnicy Sp.j.
Staszów, 28-200, Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
SONOMED
Szczecin, 71-685, Poland
Szpital Sredzki Serca Jezusowego sp. z o.o.
Środa Wielkopolska, 63-000, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
Endoterapia PFG Sp. z o.o.
Warsaw, 02-653, Poland
Futuremeds
Wroclaw, 50-088, Poland
Melita Medical Sp. z o.o.
Wroclaw, 50-449, Poland
Centrum Gastrologiczno Hepatologiczne
Wroclaw, 50-555, Poland
Lexmedica
Wroclaw, 53-114, Poland
Golden Care
Wroclaw, 54-130, Poland
Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.
Włocławek, 87-800, Poland
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, 196603, Russia
SPb SBIH "City Hospital #40 of the Kurortnyi region"
Saint Petersburg, Sestroretsk, 197706, Russia
Polyclinic Ultrasound 4D LLC
Pyatigorsk, Stavropol Kray, 357502, Russia
LLC "Alliance Biomedical-Ural Group"
Izhevsk, Udmurt Republic, 426061, Russia
LLC "Alliance Biomedical-Ural Group"
Izhevsk, 426061, Russia
LLC "Olla-Med"
Moscow, 105554, Russia
Sechenov University on the base of Institute of Translational Medicine and Biotechnology
Moscow, 119435, Russia
Limited Liability Company "Medical Center SibNovoMed"
Novosibirsk, 630005, Russia
Novosibirskiy Gastrocenter
Novosibirsk, 630007, Russia
Clinic at FSBEI HE "Omsk State Medical University" MoH RF
Omsk, 644050, Russia
LLC "New Clinic"
Pyatigorsk, 357500, Russia
Limited Liability Company "Medical Center "Reavita Med SPb" (OOO "MC "RM SPb")
Saint Petersburg, 194354, Russia
Limited Liability Company "RIAT"
Saint Petersburg, 195220, Russia
LLC "Research center Eco-Safety"
Saint Petersburg, 196143, Russia
Limited Liability Company "RIAT SPb"
Saint Petersburg, 197343, Russia
Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Hospital of the Righteous
Saint Petersburg, 197706, Russia
Private Institution Educational Organization of Higher Education
Samara, 443011, Russia
Non-state Healthcare Institution 'Railway Clinical Hospital at Samara Station of Open Joint Stock
Samara, 443029, Russia
Limited Liability Company Medical Company "Hepatolog"
Samara, 443093, Russia
State Budgetary Healthcare Institution of the Stavropol Region
Stavropol, 355017, Russia
King AbdulAziz Medical City
Riyadh, 11426, Saudi Arabia
King Khalid University Hospital
Riyadh, 11472, Saudi Arabia
Klinicko Bolnicki Centar "Bezanijska Kosa"
Zemun, Beograd, 11080, Serbia
Klinicki Centar Kragujevac
Kragujevac, Srbija, 34000, Serbia
Opsta bolnica Subotica
Subotica, Srbija, 24000, Serbia
Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija
Zrenjanin, Srbija, 23000, Serbia
KBC "Dr Dragisa Misovic-Dedinje"
Belgrade, 11040, Serbia
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Banská Bystrica, 975 17, Slovakia
ENDOMED, s.r.o.
Vranov nad Topľou, 093 01, Slovakia
Wits Clinical Research Trial Site
Parktown, Gauteng, 2193, South Africa
Dr Wright Private Practice
Claremont, Western Cape, 7708, South Africa
Kyungpook National University Hospital
Daegu, Korea, 41944, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Universitätsspital Zürich
Zurich, CH-8091, Switzerland
La Rabta Hospital
Tunis, 1007, Tunisia
Habib Thameur Hospital
Tunis, 1008, Tunisia
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi, Ic Hastaliklari
Mersin, 33110, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33110, Turkey (Türkiye)
Bulent Ecevit Universitesi Tip Fakultesi
Zonguldak, 67600, Turkey (Türkiye)
Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital", Surgery Department
Chernivtsi, 58001, Ukraine
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 n.a. prof. O.O. Shalimov
Kharkiv, 61037, Ukraine
Medical Centre Medical Clinic Blagomed LLC
Kyiv, 01023, Ukraine
Medical Center "OK Clinic+" of International Institute of Clinical Trials
Kyiv, 02091, Ukraine
Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center
Kyiv, 03680, Ukraine
Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"
Kyiv, 04078, Ukraine
Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"
Kyiv, 04107, Ukraine
Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway
Lviv, 79007, Ukraine
Vinnytsia City Clinical Hospital No.1
Vinnytsia, 21000, Ukraine
Private Small-Scale Enterprise Medical Center "Pulse"
Vinnytsia, 21001, Ukraine
Vinnytsia Regional Clinical Hospital for War Veterans
Vinnytsia, 21005, Ukraine
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
Vinnytsia, 21018, Ukraine
Medical Center "DIACENTER"LLC
Zaporizhzhia, 69076, Ukraine
Emirates Specialty Hospital
Dubai, PO BOX 505240, United Arab Emirates
Related Publications (1)
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.
PMID: 30113844DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2017
First Posted
January 10, 2018
Study Start
February 2, 2018
Primary Completion
October 19, 2023
Study Completion
October 19, 2023
Last Updated
October 30, 2024
Results First Posted
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
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.