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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395184
• Other study ID #: B7981007
• Secondary ID: 2017-003359-43PI
• Status: Completed
• Phase: Phase 2
• Start date: February 2, 2018
• Est. completion date: October 19, 2023

Study information

• Verified date: January 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: October 19, 2023
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• PF-06651600 Placebo
12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks
• PF-06651600
200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks
• Placebo PF-06700841
12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks
• PF-06700841
60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks

Locations

Country	Name	City	State
Australia	Ballarat Base Hospital	Ballarat	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Mater Misericordiae Ltd	South Brisbane	Queensland
Australia	Saint John of God Health Care Inc.	Subiaco	Western Australia
Austria	AKH Wien Universitaetsklinik fuer Innere Medizin III	Wien
Belgium	University Hospital Brussels	Jette
Belgium	University Hospitals Leuven	Leuven
Belgium	CHC MontLégia	Liége
Bosnia and Herzegovina	Javna zdravstvena ustanova Univerzitetski klinicki centar Republike Srpske,	Banja Luka
Canada	Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg	Winnipeg	Manitoba
Croatia	Klinicki Bolnicki centar Split, Zavod za gastroenterologiju	Split
Croatia	Klinicka bolnica Dubrava Zagreb	Zagreb
Croatia	Klinicki bolnicki centar Zagreb, Zavod za gastroenterologiju i hepatologiju	Zagreb
Czechia	Nemocnice Horovice, a.s.	Horovice
Czechia	Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove
Czechia	Medialpharma s.r.o.	Hradec Kralove
Czechia	MUDr. GREGAR s.r.o.	Olomouc
Czechia	Nemocnice Strakonice, a.s.	Strakonice
Czechia	Nemocnice Strakonice, a.s., Interni oddeleni	Strakonice
Georgia	Institute of Clinical Cardiology, Ltd.	Tbilisi
Georgia	LTD "Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine"	Tbilisi
Georgia	The First University Clinic of TSMU	Tbilisi
Germany	Krankenhaus Waldfriede e.V.,	Berlin
Germany	Paian MED Research GmbH	Berlin
Germany	Universitaetsklinikum Schleswig-Holstein	Kiel
Hungary	Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz	Bekescsaba
Hungary	Semmelweis Egyetem, II. Belgyogyaszati Klinika	Budapest
Hungary	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak	Budapest
Hungary	Clinfan Szolgaltato Kft.	Szekszard
Italy	A.O.Spedali Civili	Brescia	BS
Italy	IRCCS Saverio de Bellis	Castellana Grotte	Bari
Italy	Univ. "Magna Graecia" di Catanzaro	Catanzaro	CZ
Italy	A.O.U. Policlinico G. Martino	Messina
Italy	ASST Monza	Monza	MB
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Policlinico Universitario Campus Bio-Medico	Roma
Italy	Istituto Clinico Humanitas IRCCS - Sez. Autonoma di Malattie, Infiammatorie Croniche Intestinali	Rozzano	Milan
Korea, Republic of	Kyungpook National University Hospital	Daegu	Korea
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Lebanon	Saint George Hospital University Medical Center	Achrafieh
Lebanon	American University of Beirut Medical Center	Beirut
Lebanon	Ain Wazein Medical Village	El Chouf
Lebanon	Hammoud Hospital University Medical Center	Saida
Poland	Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus	Katowice
Poland	ETG Kielce	Kielce
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla	Knurow
Poland	Szpital w Knurowie Sp. z o.o.	Knurow
Poland	Samodzielny Publiczny Zespól Opieki Zdrowotnej, Pracownia Endoskopii	Koscian
Poland	Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.	Lodz
Poland	Osrodek Badan Klinicznych Appletreeclinics	Lodz
Poland	Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.	Lodz
Poland	SALVE	Lodz
Poland	Gastromed Sp. z o.o.	Lublin
Poland	IRMED	Piotrkow Trybunalski
Poland	Samodzielny Szpital Wojewodzki im. M. Kopernika w Piotrkowie Trybunalskim	Piotrkow Tryunalski
Poland	Ai Centrum Medyczne Sp. Z O.O. Sp.K.	Poznan
Poland	AM-MEDIC SP. z o.o.	Poznan
Poland	Gabinety Lekarskie Rivermed	Poznan
Poland	PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia	Poznan
Poland	PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia	Poznan
Poland	KO-MED Centra Kliniczne	Pulawy
Poland	Zaklad Opieki Zdrowotnej Medical Sp. z o.o., (endoscopy)	Pulawy
Poland	ENDOSKOPIA Sp. z o. o.	Sopot
Poland	Szpital Sredzki Serca Jezusowego sp. z o.o.	Sroda Wielkopolska
Poland	Nowe Zdrowie-CK, Kieltucki i Wspólnicy Sp.j.	Staszow
Poland	STRZEGOMSKIE CENTRUM MEDYCZNO-DIAGNOSTYCZNE Sp. z o.o.	Strzegom	Dolnoslaskie
Poland	DC-MED Sp. z o.o. Sp.k.	Swidnica	Other
Poland	SONOMED	Szczecin
Poland	Twoja Przychodnia Szczecinskie Centrum Medyczne	Szczecin
Poland	H-T. Centrum Medyczne-Endoterapia	Tychy	Silesia
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Endoterapia PFG Sp. z o.o.	Warszawa
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.	Wloclawek
Poland	Centrum Gastrologiczno Hepatologiczne	Wroclaw
Poland	Futuremeds	Wroclaw
Poland	Golden Care	Wroclaw
Poland	Lexmedica	Wroclaw
Poland	Melita Medical Sp. z o.o.	Wroclaw
Russian Federation	LLC "Alliance Biomedical-Ural Group"	Izhevsk	Udmurt Republic
Russian Federation	LLC "Alliance Biomedical-Ural Group"	Izhevsk
Russian Federation	LLC "Olla-Med"	Moscow
Russian Federation	Sechenov University on the base of Institute of Translational Medicine and Biotechnology	Moscow
Russian Federation	Limited Liability Company "Medical Center SibNovoMed"	Novosibirsk
Russian Federation	Novosibirskiy Gastrocenter	Novosibirsk
Russian Federation	Clinic at FSBEI HE "Omsk State Medical University" MoH RF	Omsk
Russian Federation	Private Medical Institution "Euromedservice"	Pushkin	Saint-petersburg
Russian Federation	LLC "New Clinic"	Pyatigorsk
Russian Federation	Polyclinic Ultrasound 4D LLC	Pyatigorsk	Stavropol Region
Russian Federation	LLC "Research center Eco-Safety"	Saint Petersburg
Russian Federation	Limited Liability Company "Medical Center "Reavita Med SPb" (OOO "MC "RM SPb")	Saint-Petersburg
Russian Federation	Limited Liability Company "RIAT SPb"	Saint-Petersburg
Russian Federation	Limited Liability Company "RIAT"	Saint-Petersburg
Russian Federation	SPb SBIH "City Hospital #40 of the Kurortnyi region"	Saint-Petersburg	Sestroretsk
Russian Federation	Limited Liability Company Medical Company "Hepatolog"	Samara
Russian Federation	Non-state Healthcare Institution 'Railway Clinical Hospital at Samara Station of Open Joint Stock	Samara
Russian Federation	Private Institution Educational Organization of Higher Education	Samara
Russian Federation	Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Hospital of the Righteous	St. Petersburg
Russian Federation	State Budgetary Healthcare Institution of the Stavropol Region	Stavropol
Saudi Arabia	King AbdulAziz Medical City	Riyadh
Saudi Arabia	King Khalid University Hospital	Riyadh
Serbia	KBC "Dr Dragisa Misovic-Dedinje"	Beograd
Serbia	Klinicki Centar Kragujevac	Kragujevac	Srbija
Serbia	Opsta bolnica Subotica	Subotica	Srbija
Serbia	Klinicko Bolnicki Centar "Bezanijska Kosa"	Zemun	Beograd
Serbia	Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija	Zrenjanin	Srbija
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica	Banska Bystrica
Slovakia	ENDOMED, s.r.o.	Vranov nad Toplou
South Africa	Dr Wright Private Practice	Claremont	Western CAPE
South Africa	Wits Clinical Research Trial Site	Parktown	Gauteng
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcon	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Switzerland	Universitätsspital Zürich	Zürich
Tunisia	Habib Thameur Hospital	Tunis
Tunisia	La Rabta Hospital	Tunis
Turkey	Hacettepe Universitesi Tip Fakultesi	Ankara
Turkey	Kocaeli Universitesi Tip Fakultesi	Kocaeli
Turkey	Mersin Universitesi Tip Fakultesi Hastanesi	Mersin
Turkey	Mersin Universitesi Tip Fakultesi Hastanesi, Ic Hastaliklari	Mersin
Turkey	Bulent Ecevit Universitesi Tip Fakultesi	Zonguldak
Ukraine	Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital", Surgery Departm	Chernivtsi
Ukraine	Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 n.a. prof. O.O. Shalimov	Kharkiv
Ukraine	Medical Center "OK Clinic+" of International Institute of Clinical Trials	Kyiv
Ukraine	Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center	Kyiv
Ukraine	Medical Centre Medical Clinic Blagomed LLC	Kyiv
Ukraine	Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"	Kyiv
Ukraine	Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"	Kyiv
Ukraine	Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway	Lviv
Ukraine	Private Small-Scale Enterprise Medical Center "Pulse"	Vinnytsia
Ukraine	Vinnytsia City Clinical Hospital No.1	Vinnytsia
Ukraine	Vinnytsia Regional Clinical Hospital for War Veterans	Vinnytsia
Ukraine	Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov	Vinnytsia
Ukraine	Medical Center "DIACENTER"LLC	Zaporizhzhia
United Arab Emirates	Emirates Specialty Hospital	Dubai
United States	First Street Hospital	Bellaire	Texas
United States	First Street Surgical Center	Bellaire	Texas
United States	Brighton Surgical Center	Beverly Hills	California
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Mass Eye and Ear, Longwood	Boston	Massachusetts
United States	UNC Hospitals	Chapel Hill	North Carolina
United States	UNC Hospitals Endoscopy Center at Meadowmont	Chapel Hill	North Carolina
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts
United States	Chevy Chase Endoscopy Center	Chevy Chase	Maryland
United States	MGG Group Co., Inc., Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Gastro Florida	Clearwater	Florida
United States	Gastro Florida	Clearwater	Florida
United States	Gastro Florida	Clearwater	Florida
United States	West Coast Endoscopy Center	Clearwater	Florida
United States	Front Range Endoscopy Center	Colorado Springs	Colorado
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Dothan Surgery Center	Dothan	Alabama
United States	Gut P.C., dba Digestive Health Specialists of the Southeast	Dothan	Alabama
United States	Gastroenterology Associates of Northern VA	Fairfax	Virginia
United States	Gastroenterology Associates of Northern Virginia	Fairfax	Virginia
United States	Verity Research, Inc.	Fairfax	Virginia
United States	UNC GI Procedures Hillsborough	Hillsborough	North Carolina
United States	Hermann Drive Surgical Hospital	Houston	Texas
United States	Pearland Surgery Center	Houston	Texas
United States	UF Health Jacksonville - Gastroenterology Emerson	Jacksonville	Florida
United States	Holston Medical Group	Kingsport	Tennessee
United States	Holston Valley Surgery Center	Kingsport	Tennessee
United States	Entertainment Medical Group	Los Angeles	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC	Los Angeles	California
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Eastside Endoscopy Center	Macomb	Michigan
United States	Vanderbilt GI Endoscopy Lab at One Hundred Oaks	Nashville	Tennessee
United States	Vanderbilt Inflammatory Bowel Disease Clinic	Nashville	Tennessee
United States	Vanderbilt Inflammatory Bowel Disease Clinic	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)	New York	New York
United States	New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Weill Cornell Medical College - New York Presbyterian Hospital	New York	New York
United States	Weill Cornell Medical College - New York Presbyterian Hospital	New York	New York
United States	Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)	New York	New York
United States	DiGiovanna Institute for Medical Education And Research	North Massapequa	New York
United States	HMD Research LLC	Orlando	Florida
United States	Millenia Surgery Center	Orlando	Florida
United States	Stanford Medicine Outpatient Center - Digestive Health Center	Redwood City	California
United States	Capitol Research	Rockville	Maryland
United States	WestGlen Gastrointestinal Consultants, P.A.	Shawnee Mission	Kansas
United States	GI Alliance	Southlake	Texas
United States	Lonestar Endoscopy, LLP	Southlake	Texas
United States	Texas Digestive Disease Consultants (Administrative, Regulatory)	Southlake	Texas
United States	Gastroenterology Associates of the Piedmont, PA	Winston-Salem	North Carolina
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Canada,  Croatia,  Czechia,  Georgia,  Germany,  Hungary,  Italy,  Korea, Republic of,  Lebanon,  Poland,  Russian Federation,  Saudi Arabia,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Tunisia,  Turkey,  Ukraine,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving SES CD 50 (>50% reduction in SES CD from baseline) at Week 12.		12 weeks
Primary	Number of subjects with adverse events		Baseline of extension period (Week 12) to week 68
Primary	Number of subjects with serious adverse events		Baseline of extension period (Week 12) to week 68
Primary	Number of subjects with electrocardiogram findings of potential clinical importance		Baseline of extension period (Week 12) to week 68
Primary	Number of subjects with laboratory tests findings of potential clinical importance		Baseline of extension period (Week 12) to week 68
Primary	Number of subjects withdrawal due to adverse events		Baseline of extension period (Week 12) to week 68
Primary	Number of subjects with vital signs findings of potential clinical importance		Baseline of extension period (Week 12) to week 68
Secondary	Number of participants with potentially clinically important serious infections findings		64 weeks
Secondary	Mean change from baseline in SES-CD score at Week 12.		Baseline, week 12
Secondary	Proportion of subjects achieving SES-CD 25 at Week 12.	Number of subjects achieving SES-CD 25 at Week 12.	Baseline, week 12
Secondary	Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.	Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.	Week 12
Secondary	Proportion of subjects achieving mucosal healing at Week 12.	Number of subjects achieving mucosal healing at Week 12.	Week 12
Secondary	Number of subjects with adverse events	Number of participants with reported adverse events	Baseline of induction period to week 12
Secondary	Number of subjects with serious adverse events	Number of participants with reported serious adverse events	Baseline of induction period to week 12
Secondary	Number of subjects with electrocardiogram findings of potential clinical importance.	Number of participants with potentially clinically important electrocardiogram findings.	Baseline of induction period to week 12
Secondary	Number of subjects withdrawal due to adverse events	Number of subjects withdrawal due to adverse events.	Baseline of induction period to week 12
Secondary	Number of subjects with vital signs findings of potential clinical importance.	Number of participants with potentially clinically important vital signs findings.	Baseline of induction period to week 12
Secondary	Number of subjects with laboratory tests findings of potential clinical importance.	Number of participants with potentially clinically important laboratory findings.	Baseline of induction period to week 12
Secondary	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.	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	week 64
Secondary	Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.	Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.	week 64
Secondary	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

External Links

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