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

• Sponsor: Pfizer (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03395184
• Collaborator: (none)
• Enrollment: 243
• Locations: 188
• Arms: 2
• Anticipated Duration (Months): 68.9
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0

Study Details

Study Description

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: PF-06651600 Placebo; Drug: PF-06651600; Drug: Placebo PF-06700841; Drug: PF-06700841	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 243 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: Feb 2, 2018
• Anticipated Primary Completion Date: Oct 30, 2023
• Anticipated Study Completion Date: Oct 30, 2023

Arms and Interventions

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: PF-06651600 Placebo; 12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks; Drug: PF-06651600; 200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects achieving SES CD 50 (>50% reduction in SES CD from baseline) at Week 12. [12 weeks]

2. Number of subjects with adverse events [Baseline of extension period (Week 12) to week 68]

3. Number of subjects with serious adverse events [Baseline of extension period (Week 12) to week 68]

4. Number of subjects with electrocardiogram findings of potential clinical importance [Baseline of extension period (Week 12) to week 68]

5. Number of subjects with laboratory tests findings of potential clinical importance [Baseline of extension period (Week 12) to week 68]

6. Number of subjects withdrawal due to adverse events [Baseline of extension period (Week 12) to week 68]

7. Number of subjects with vital signs findings of potential clinical importance [Baseline of extension period (Week 12) to week 68]

Secondary Outcome Measures

1. Number of participants with potentially clinically important serious infections findings [64 weeks]

2. Mean change from baseline in SES-CD score at Week 12. [Baseline, week 12]

3. Proportion of subjects achieving SES-CD 25 at Week 12. [Baseline, week 12]

   Number of subjects achieving SES-CD 25 at Week 12.

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

   Number of subjects achieving mucosal healing at Week 12.

6. Number of subjects with adverse events [Baseline of induction period to week 12]

   Number of participants with reported adverse events

7. Number of subjects with serious adverse events [Baseline of induction period to week 12]

   Number of participants with reported serious adverse events

8. Number of subjects with electrocardiogram findings of potential clinical importance. [Baseline of induction period to week 12]

   Number of participants with potentially clinically important electrocardiogram findings.

9. Number of subjects withdrawal due to adverse events [Baseline of induction period to week 12]

   Number of subjects withdrawal due to adverse events.

10. Number of subjects with vital signs findings of potential clinical importance. [Baseline of induction period to week 12]

    Number of participants with potentially clinically important vital signs findings.

11. Number of subjects with laboratory tests findings of potential clinical importance. [Baseline of induction period to week 12]

    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. [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. [week 64]

    Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.

14. Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of > or equal 3 points from baseline in SES CD score) at Week 12. [Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

1. 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:

14. 9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.

15. IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.

16. Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.

17. 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;

1. Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.

2. Ustekinumab within 8 weeks prior to baseline.

3. Interferon therapy within 8 weeks prior to baseline.

4. 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).

5. Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.

6. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.

7. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.

8. Subjects who have received other JAK inhibitors within 3 months prior to baseline.

9. Subjects who have not responded to or have been intolerant of other JAK inhibitors.

10. 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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dothan Surgery Center	Dothan	Alabama	United States	36301
2	Gut P.C., dba Digestive Health Specialists of the Southeast	Dothan	Alabama	United States	36305
3	Brighton Surgical Center	Beverly Hills	California	United States	90210
4	Entertainment Medical Group	Los Angeles	California	United States	90036
5	Gastrointestinal Biosciences Clinical Trials, LLC	Los Angeles	California	United States	90067
6	Stanford Medicine Outpatient Center - Digestive Health Center	Redwood City	California	United States	94063
7	Front Range Endoscopy Center	Colorado Springs	Colorado	United States	80903
8	Peak Gastroenterology Associates	Colorado Springs	Colorado	United States	80907
9	Gastro Florida	Clearwater	Florida	United States	33756-3839
10	West Coast Endoscopy Center	Clearwater	Florida	United States	33756
11	Gastro Florida	Clearwater	Florida	United States	33762
12	UF Health Jacksonville - Gastroenterology Emerson	Jacksonville	Florida	United States	32207
13	Millenia Surgery Center	Orlando	Florida	United States	32811
14	HMD Research LLC	Orlando	Florida	United States	32819
15	Treasure Valley Medical Research	Boise	Idaho	United States	83706
16	WestGlen Gastrointestinal Consultants, P.A.	Shawnee Mission	Kansas	United States	66217
17	Chevy Chase Endoscopy Center	Chevy Chase	Maryland	United States	20815
18	MGG Group Co., Inc., Chevy Chase Clinical Research	Chevy Chase	Maryland	United States	20815
19	Capitol Research	Rockville	Maryland	United States	20850
20	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
21	Mass Eye and Ear, Longwood	Boston	Massachusetts	United States	02115
22	Brigham and Women's Hospital	Chestnut Hill	Massachusetts	United States	02467
23	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan	United States	48047
24	Eastside Endoscopy Center	Macomb	Michigan	United States	48044
25	Weill Cornell Medical College - New York Presbyterian Hospital	New York	New York	United States	10021
26	Weill Cornell Medical College	New York	New York	United States	10021
27	New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)	New York	New York	United States	10065
28	New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy	New York	New York	United States	10065
29	Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)	New York	New York	United States	10065
30	Weill Cornell Medical College - New York Presbyterian Hospital	New York	New York	United States	10065
31	DiGiovanna Institute for Medical Education And Research	North Massapequa	New York	United States	11758-1853
32	UNC Hospitals	Chapel Hill	North Carolina	United States	27514
33	UNC Hospitals Endoscopy Center at Meadowmont	Chapel Hill	North Carolina	United States	27517
34	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
35	UNC GI Procedures Hillsborough	Hillsborough	North Carolina	United States	27278
36	Gastroenterology Associates of the Piedmont, PA	Winston-Salem	North Carolina	United States	27103
37	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina	United States	27103
38	Holston Medical Group	Kingsport	Tennessee	United States	37660
39	Holston Valley Surgery Center	Kingsport	Tennessee	United States	37660
40	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212-1375
41	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212-1610
42	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-5543
43	First Street Hospital	Bellaire	Texas	United States	77401
44	First Street Surgical Center	Bellaire	Texas	United States	77401
45	Pearland Surgery Center	Houston	Texas	United States	77047
46	GI Alliance	Southlake	Texas	United States	76092
47	Lonestar Endoscopy, LLP	Southlake	Texas	United States	76092
48	Gastroenterology Associates of Northern VA	Fairfax	Virginia	United States	22031
49	Gastroenterology Associates of Northern Virginia	Fairfax	Virginia	United States	22031
50	Verity Research, Inc.	Fairfax	Virginia	United States	22031
51	Blue Ridge Medical Research	Lynchburg	Virginia	United States	24502
52	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
53	Mater Misericordiae Ltd	South Brisbane	Queensland	Australia	4101
54	Ballarat Base Hospital	Ballarat	Victoria	Australia	3350
55	Saint John of God Health Care Inc.	Subiaco	Western Australia	Australia	6008
56	AKH Wien Universitaetsklinik fuer Innere Medizin III	Wien		Austria	1090
57	University Hospital Brussels	Jette		Belgium	1090
58	University Hospitals Leuven	Leuven		Belgium	3000
59	CHC MontLégia	Liége		Belgium	4000
60	Javna zdravstvena ustanova Univerzitetski klinicki centar Republike Srpske,	Banja Luka		Bosnia and Herzegovina	78000
61	Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg	Winnipeg	Manitoba	Canada	R3A 1R9
62	Klinicki Bolnicki centar Split, Zavod za gastroenterologiju	Split		Croatia	21000
63	Klinicka bolnica Dubrava Zagreb	Zagreb		Croatia	10000
64	Klinicki bolnicki centar Zagreb, Zavod za gastroenterologiju i hepatologiju	Zagreb		Croatia	10000
65	Nemocnice Horovice, a.s.	Horovice		Czechia	268 31
66	Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove		Czechia	500 12
67	Medialpharma s.r.o.	Hradec Kralove		Czechia	500 12
68	MUDr. GREGAR s.r.o.	Olomouc		Czechia	77900
69	Nemocnice Strakonice, a.s., Interni oddeleni	Strakonice		Czechia	386 01
70	Nemocnice Strakonice, a.s.	Strakonice		Czechia	386 29
71	LTD "Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine"	Tbilisi		Georgia	0112
72	The First University Clinic of TSMU	Tbilisi		Georgia	0141
73	Institute of Clinical Cardiology, Ltd.	Tbilisi		Georgia	0159
74	Paian MED Research GmbH	Berlin		Germany	10318
75	Krankenhaus Waldfriede e.V.,	Berlin		Germany	14163
76	Universitaetsklinikum Schleswig-Holstein	Kiel		Germany	24105
77	Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz	Bekescsaba		Hungary	5600
78	Semmelweis Egyetem, II. Belgyogyaszati Klinika	Budapest		Hungary	1088
79	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak	Budapest		Hungary	1125
80	Clinfan Szolgaltato Kft.	Szekszard		Hungary	7100
81	IRCCS Saverio de Bellis	Castellana Grotte	Bari	Italy	70013
82	A.O.Spedali Civili	Brescia	BS	Italy	25123
83	Univ. "Magna Graecia" di Catanzaro	Catanzaro	CZ	Italy	88100
84	ASST Monza	Monza	MB	Italy	20090
85	Istituto Clinico Humanitas IRCCS - Sez. Autonoma di Malattie, Infiammatorie Croniche Intestinali	Rozzano	Milan	Italy	20089
86	A.O.U. Policlinico G. Martino	Messina		Italy	98125
87	Azienda Ospedaliera di Padova	Padova		Italy	35128
88	Policlinico Universitario Campus Bio-Medico	Roma		Italy	00128
89	Kyungpook National University Hospital	Daegu	Korea	Korea, Republic of	41944
90	Kyung Hee University Hospital	Seoul		Korea, Republic of	02447
91	Kangbuk Samsung Hospital	Seoul		Korea, Republic of	03181
92	Saint George Hospital University Medical Center	Achrafieh		Lebanon
93	American University of Beirut Medical Center	Beirut		Lebanon
94	Ain Wazein Medical Village	El Chouf		Lebanon
95	Hammoud Hospital University Medical Center	Saida		Lebanon
96	STRZEGOMSKIE CENTRUM MEDYCZNO-DIAGNOSTYCZNE Sp. z o.o.	Strzegom	Dolnoslaskie	Poland	58-150
97	DC-MED Sp. z o.o. Sp.k.	Swidnica	Other	Poland	58-100
98	H-T. Centrum Medyczne-Endoterapia	Tychy	Silesia	Poland	43-100
99	Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus	Katowice		Poland	40-659
100	ETG Kielce	Kielce		Poland	25-355
101	Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla	Knurow		Poland	44-190
102	Szpital w Knurowie Sp. z o.o.	Knurow		Poland	44-190
103	Samodzielny Publiczny Zespół Opieki Zdrowotnej, Pracownia Endoskopii	Koscian		Poland	64-000
104	Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.	Lodz		Poland	90-302
105	Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.	Lodz		Poland	90-302
106	Ośrodek Badań Klinicznych Appletreeclinics	Lodz		Poland	90-349
107	SALVE	Lodz		Poland	92-551
108	Gastromed Sp. z o.o.	Lublin		Poland	20-582
109	IRMED	Piotrkow Trybunalski		Poland	97-300
110	Samodzielny Szpital Wojewodzki im. M. Kopernika w Piotrkowie Trybunalskim	Piotrkow Tryunalski		Poland	91-300
111	PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia	Poznan		Poland	60-848
112	Ai Centrum Medyczne Sp. Z O.O. Sp.K.	Poznan		Poland	61-113
113	AM-MEDIC SP. z o.o.	Poznan		Poland	61-315
114	Gabinety Lekarskie Rivermed	Poznan		Poland	61-441
115	PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia	Poznan		Poland	61-731
116	KO-MED Centra Kliniczne	Pulawy		Poland	24-100
117	Zaklad Opieki Zdrowotnej Medical Sp. z o.o., (endoscopy)	Pulawy		Poland	24-110
118	ENDOSKOPIA Sp. z o. o.	Sopot		Poland	81-756
119	Szpital Sredzki Serca Jezusowego sp. z o.o.	Sroda Wielkopolska		Poland	63-000
120	Nowe Zdrowie-CK, Kiełtucki i Wspólnicy Sp.j.	Staszow		Poland	28-200
121	Twoja Przychodnia Szczecinskie Centrum Medyczne	Szczecin		Poland	71-434
122	SONOMED	Szczecin		Poland	71-685
123	Centrum Zdrowia MDM	Warszawa		Poland	00-635
124	WIP Warsaw IBD Point Profesor Kierkus	Warszawa		Poland	00-728
125	Endoterapia PFG Sp. z o.o.	Warszawa		Poland	02-653
126	Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.	Wloclawek		Poland	87-800
127	Futuremeds	Wroclaw		Poland	50-088
128	Melita Medical Sp. z o.o.	Wroclaw		Poland	50-449
129	Centrum Gastrologiczno Hepatologiczne	Wroclaw		Poland	50-555
130	Lexmedica	Wroclaw		Poland	53-114
131	Golden Care	Wroclaw		Poland	54-130
132	Private Medical Institution "Euromedservice"	Pushkin	Saint-petersburg	Russian Federation	196603
133	SPb SBIH "City Hospital #40 of the Kurortnyi region"	Saint-Petersburg	Sestroretsk	Russian Federation	197706
134	Polyclinic Ultrasound 4D LLC	Pyatigorsk	Stavropol Region	Russian Federation	357502
135	LLC "Alliance Biomedical-Ural Group"	Izhevsk		Russian Federation	426061
136	LLC "Olla-Med"	Moscow		Russian Federation	105554
137	Sechenov University on the base of Institute of Translational Medicine and Biotechnology	Moscow		Russian Federation	119435
138	Limited Liability Company "Medical Center SibNovoMed"	Novosibirsk		Russian Federation	630005
139	Novosibirskiy Gastrocenter	Novosibirsk		Russian Federation	630007
140	Clinic at FSBEI HE "Omsk State Medical University" MoH RF	Omsk		Russian Federation	644050
141	LLC "New Clinic"	Pyatigorsk		Russian Federation	357500
142	LLC "Research center Eco-Safety"	Saint Petersburg		Russian Federation	196143
143	Limited Liability Company "Medical Center "Reavita Med SPb" (OOO "MC "RM SPb")	Saint-Petersburg		Russian Federation	194354
144	Limited Liability Company "RIAT"	Saint-Petersburg		Russian Federation	195220
145	Limited Liability Company "RIAT SPb"	Saint-Petersburg		Russian Federation	197343
146	Private Institution Educational Organization of Higher Education	Samara		Russian Federation	443011
147	Non-state Healthcare Institution 'Railway Clinical Hospital at Samara Station of Open Joint Stock	Samara		Russian Federation	443029
148	Limited Liability Company Medical Company "Hepatolog"	Samara		Russian Federation	443093
149	Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Hospital of the Righteous	St. Petersburg		Russian Federation	197706
150	State Budgetary Healthcare Institution of the Stavropol Region	Stavropol		Russian Federation	355017
151	King AbdulAziz Medical City	Riyadh		Saudi Arabia	11426
152	King Khalid University Hospital	Riyadh		Saudi Arabia	11472
153	Klinicko Bolnicki Centar "Bezanijska Kosa"	Zemun	Beograd	Serbia	11080
154	Klinicki Centar Kragujevac	Kragujevac	Srbija	Serbia	34000
155	Opsta bolnica Subotica	Subotica	Srbija	Serbia	24000
156	Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija	Zrenjanin	Srbija	Serbia	23000
157	KBC "Dr Dragisa Misovic-Dedinje"	Beograd		Serbia	11040
158	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica	Banska Bystrica		Slovakia	975 17
159	ENDOMED, s.r.o.	Vranov nad Toplou		Slovakia	093 01
160	Wits Clinical Research Trial Site	Parktown	Gauteng	South Africa	2193
161	Dr Wright Private Practice	Claremont	Western CAPE	South Africa	7708
162	Hospital Universitario Marques de Valdecilla	Santander	Cantabria	Spain	39008
163	Hospital Universitario Fundacion Alcorcon	Alcorcon	Madrid	Spain	28922
164	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
165	Hospital Universitario Virgen del Rocio	Sevilla		Spain	41013
166	Hospital Universitari i Politecnic La Fe	Valencia		Spain	46026
167	Universitätsspital Zürich	Zürich		Switzerland	CH-8091
168	La Rabta Hospital	Tunis		Tunisia	1007
169	Habib Thameur Hospital	Tunis		Tunisia	1008
170	Hacettepe Universitesi Tip Fakultesi	Ankara		Turkey	06230
171	Kocaeli Universitesi Tip Fakultesi	Kocaeli		Turkey	41380
172	Mersin Universitesi Tip Fakultesi Hastanesi, Ic Hastaliklari	Mersin		Turkey	33110
173	Mersin Universitesi Tip Fakultesi Hastanesi	Mersin		Turkey	33110
174	Bulent Ecevit Universitesi Tip Fakultesi	Zonguldak		Turkey	67600
175	Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital", Surgery Depart	Chernivtsi		Ukraine	58001
176	Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 n.a. prof. O.O. Shalimov	Kharkiv		Ukraine	61037
177	Medical Centre Medical Clinic Blagomed LLC	Kyiv		Ukraine	01023
178	Medical Center "OK Clinic+" of International Institute of Clinical Trials	Kyiv		Ukraine	02091
179	Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center	Kyiv		Ukraine	03680
180	Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"	Kyiv		Ukraine	04078
181	Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"	Kyiv		Ukraine	04107
182	Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway	Lviv		Ukraine	79007
183	Vinnytsia City Clinical Hospital No.1	Vinnytsia		Ukraine	21000
184	Private Small-Scale Enterprise Medical Center "Pulse"	Vinnytsia		Ukraine	21001
185	Vinnytsia Regional Clinical Hospital for War Veterans	Vinnytsia		Ukraine	21005
186	Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov	Vinnytsia		Ukraine	21018
187	Medical Center "DIACENTER"LLC	Zaporizhzhia		Ukraine	69076
188	Emirates Specialty Hospital	Dubai		United Arab Emirates	PO BOX 505240

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03395184
• Other Study ID Numbers: B7981007; 2017-003359-43; PIZZICATO
• First Posted: Jan 10, 2018
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Crohn Disease; PF-06700841

Study Results

No Results Posted as of Aug 19, 2022