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

Primary Purpose

Crohn's Disease

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PF-06651600 Placebo

PF-06651600

Placebo PF-06700841

PF-06700841

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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:
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.

Sites / Locations

Dothan Surgery Center
Gut P.C., dba Digestive Health Specialists of the Southeast
Brighton Surgical Center
Entertainment Medical Group
Gastrointestinal Biosciences Clinical Trials, LLC
Stanford Medicine Outpatient Center - Digestive Health Center
Front Range Endoscopy Center
Peak Gastroenterology Associates
Gastro Florida
West Coast Endoscopy Center
Gastro Florida
UF Health Jacksonville - Gastroenterology Emerson
Millenia Surgery Center
HMD Research LLC
Treasure Valley Medical Research
WestGlen Gastrointestinal Consultants, P.A.
Chevy Chase Endoscopy Center
MGG Group Co., Inc., Chevy Chase Clinical Research
Capitol Research
Brigham and Women's Hospital
Mass Eye and Ear, Longwood
Brigham and Women's Hospital
Clinical Research Institute of Michigan, LLC
Eastside Endoscopy Center
Weill Cornell Medical College - New York Presbyterian Hospital
Weill Cornell Medical College
New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)
New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)
Weill Cornell Medical College - New York Presbyterian Hospital
DiGiovanna Institute for Medical Education And Research
UNC Hospitals
UNC Hospitals Endoscopy Center at Meadowmont
University of North Carolina at Chapel Hill
UNC GI Procedures Hillsborough
Gastroenterology Associates of the Piedmont, PA
PMG Research of Winston-Salem, LLC
Holston Medical Group
Holston Valley Surgery Center
Vanderbilt University Medical Center
Vanderbilt University Medical Center
Vanderbilt University Medical Center
First Street Hospital
First Street Surgical Center
Pearland Surgery Center
GI Alliance
Lonestar Endoscopy, LLP
Gastroenterology Associates of Northern VA
Gastroenterology Associates of Northern Virginia
Verity Research, Inc.
Blue Ridge Medical Research
Concord Repatriation General Hospital
Mater Misericordiae Ltd
Ballarat Base Hospital
Saint John of God Health Care Inc.
AKH Wien Universitaetsklinik fuer Innere Medizin III
University Hospital Brussels
University Hospitals Leuven
CHC MontLégia
Javna zdravstvena ustanova Univerzitetski klinicki centar Republike Srpske,
Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg
Klinicki Bolnicki centar Split, Zavod za gastroenterologiju
Klinicka bolnica Dubrava Zagreb
Klinicki bolnicki centar Zagreb, Zavod za gastroenterologiju i hepatologiju
Nemocnice Horovice, a.s.
Hepato-Gastroenterologie HK s.r.o.
Medialpharma s.r.o.
MUDr. GREGAR s.r.o.
Nemocnice Strakonice, a.s., Interni oddeleni
Nemocnice Strakonice, a.s.
LTD "Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine"
The First University Clinic of TSMU
Institute of Clinical Cardiology, Ltd.
Paian MED Research GmbH
Krankenhaus Waldfriede e.V.,
Universitaetsklinikum Schleswig-Holstein
Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz
Semmelweis Egyetem, II. Belgyogyaszati Klinika
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Clinfan Szolgaltato Kft.
IRCCS Saverio de Bellis
A.O.Spedali Civili
Univ. "Magna Graecia" di Catanzaro
ASST Monza
Istituto Clinico Humanitas IRCCS - Sez. Autonoma di Malattie, Infiammatorie Croniche Intestinali
A.O.U. Policlinico G. Martino
Azienda Ospedaliera di Padova
Policlinico Universitario Campus Bio-Medico
Kyungpook National University Hospital
Kyung Hee University Hospital
Kangbuk Samsung Hospital
Saint George Hospital University Medical Center
American University of Beirut Medical Center
Ain Wazein Medical Village
Hammoud Hospital University Medical Center
STRZEGOMSKIE CENTRUM MEDYCZNO-DIAGNOSTYCZNE Sp. z o.o.
DC-MED Sp. z o.o. Sp.k.
H-T. Centrum Medyczne-Endoterapia
Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus
ETG Kielce
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Szpital w Knurowie Sp. z o.o.
Samodzielny Publiczny Zespół Opieki Zdrowotnej, Pracownia Endoskopii
Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.
Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp z o.o.
Ośrodek Badań Klinicznych Appletreeclinics
SALVE
Gastromed Sp. z o.o.
IRMED
Samodzielny Szpital Wojewodzki im. M. Kopernika w Piotrkowie Trybunalskim
PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
AM-MEDIC SP. z o.o.
Gabinety Lekarskie Rivermed
PRZYCHODNIA SPECJALISTYCZNA MEDIC-R Clinical Research Center Spolka z ograniczona odpowiedzialnoscia
KO-MED Centra Kliniczne
Zaklad Opieki Zdrowotnej Medical Sp. z o.o., (endoscopy)
ENDOSKOPIA Sp. z o. o.
Szpital Sredzki Serca Jezusowego sp. z o.o.
Nowe Zdrowie-CK, Kiełtucki i Wspólnicy Sp.j.
Twoja Przychodnia Szczecinskie Centrum Medyczne
SONOMED
Centrum Zdrowia MDM
WIP Warsaw IBD Point Profesor Kierkus
Endoterapia PFG Sp. z o.o.
Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.
Futuremeds
Melita Medical Sp. z o.o.
Centrum Gastrologiczno Hepatologiczne
Lexmedica
Golden Care
Private Medical Institution "Euromedservice"
SPb SBIH "City Hospital #40 of the Kurortnyi region"
Polyclinic Ultrasound 4D LLC
LLC "Alliance Biomedical-Ural Group"
LLC "Olla-Med"
Sechenov University on the base of Institute of Translational Medicine and Biotechnology
Limited Liability Company "Medical Center SibNovoMed"
Novosibirskiy Gastrocenter
Clinic at FSBEI HE "Omsk State Medical University" MoH RF
LLC "New Clinic"
LLC "Research center Eco-Safety"
Limited Liability Company "Medical Center "Reavita Med SPb" (OOO "MC "RM SPb")
Limited Liability Company "RIAT"
Limited Liability Company "RIAT SPb"
Private Institution Educational Organization of Higher Education
Non-state Healthcare Institution 'Railway Clinical Hospital at Samara Station of Open Joint Stock
Limited Liability Company Medical Company "Hepatolog"
Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Hospital of the Righteous
State Budgetary Healthcare Institution of the Stavropol Region
King AbdulAziz Medical City
King Khalid University Hospital
Klinicko Bolnicki Centar "Bezanijska Kosa"
Klinicki Centar Kragujevac
Opsta bolnica Subotica
Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija
KBC "Dr Dragisa Misovic-Dedinje"
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
ENDOMED, s.r.o.
Wits Clinical Research Trial Site
Dr Wright Private Practice
Hospital Universitario Marques de Valdecilla
Hospital Universitario Fundacion Alcorcon
Hospital Universitario Ramon y Cajal
Hospital Universitario Virgen del Rocio
Hospital Universitari i Politecnic La Fe
Universitätsspital Zürich
La Rabta Hospital
Habib Thameur Hospital
Hacettepe Universitesi Tip Fakultesi
Kocaeli Universitesi Tip Fakultesi
Mersin Universitesi Tip Fakultesi Hastanesi, Ic Hastaliklari
Mersin Universitesi Tip Fakultesi Hastanesi
Bulent Ecevit Universitesi Tip Fakultesi
Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital", Surgery Depart
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 n.a. prof. O.O. Shalimov
Medical Centre Medical Clinic Blagomed LLC
Medical Center "OK Clinic+" of International Institute of Clinical Trials
Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center
Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"
Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"
Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway
Vinnytsia City Clinical Hospital No.1
Private Small-Scale Enterprise Medical Center "Pulse"
Vinnytsia Regional Clinical Hospital for War Veterans
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
Medical Center "DIACENTER"LLC
Emirates Specialty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PF-06700841 or placebo

PF-06651600 or placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Number of subjects with adverse events

Number of subjects with serious adverse events

Number of subjects with electrocardiogram findings of potential clinical importance

Number of subjects with laboratory tests findings of potential clinical importance

Number of subjects withdrawal due to adverse events

Number of subjects with vital signs findings of potential clinical importance

Secondary Outcome Measures

Number of participants with potentially clinically important serious infections findings

Mean change from baseline in SES-CD score at Week 12.

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

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

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.

Proportion of subjects achieving mucosal healing at Week 12.

Number of subjects achieving mucosal healing at Week 12.

Number of subjects with adverse events

Number of participants with reported adverse events

Number of subjects with serious adverse events

Number of participants with reported serious adverse events

Number of subjects with electrocardiogram findings of potential clinical importance.

Number of participants with potentially clinically important electrocardiogram findings.

Number of subjects withdrawal due to adverse events

Number of subjects withdrawal due to adverse events.

Number of subjects with vital signs findings of potential clinical importance.

Number of participants with potentially clinically important vital signs findings.

Number of subjects with laboratory tests findings of potential clinical importance.

Number of participants with potentially clinically important laboratory findings.

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

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.

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

Full Information

NCT ID

NCT03395184

First Posted

December 5, 2017

Last Updated

September 6, 2023

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03395184

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 2, 2018 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

244 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-06700841 or placebo

Arm Type

Experimental

Arm Title

PF-06651600 or placebo

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

PF-06651600 Placebo

Intervention Description

12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks

Intervention Type

Drug

Intervention Name(s)

PF-06651600

Intervention Description

200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo PF-06700841

Intervention Description

12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks

Intervention Type

Drug

Intervention Name(s)

PF-06700841

Intervention Description

60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Title

Number of subjects with adverse events

Time Frame