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Study To Evaluate The Efficac...

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

Last Updated: 2024-10-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-02

Study Completion Date

2023-10-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PF-06700841 or placebo

Group Type EXPERIMENTAL

Placebo PF-06700841

Intervention Type DRUG

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

PF-06700841

Intervention Type DRUG

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

PF-06651600 or placebo

Group Type EXPERIMENTAL

PF-06651600 Placebo

Intervention Type DRUG

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

PF-06651600

Intervention Type DRUG

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

Interventions

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PF-06651600 Placebo

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

Intervention Type DRUG

PF-06651600

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

Intervention Type DRUG

Placebo PF-06700841

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

Intervention Type DRUG

PF-06700841

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Dothan Surgery Center

Dothan, Alabama, United States

Site Status

Gut P.C., dba Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Site Status

Brighton Surgical Center

Beverly Hills, California, United States

Site Status

Entertainment Medical Group

Los Angeles, California, United States

Site Status

Gastrointestinal Biosciences Clinical Trials, LLC

Los Angeles, California, United States

Site Status

Stanford Medicine Outpatient Center - Digestive Health Center

Redwood City, California, United States

Site Status

Front Range Endoscopy Center

Colorado Springs, Colorado, United States

Site Status

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Site Status

Gastro Florida

Clearwater, Florida, United States

Site Status

Gastro Florida

Clearwater, Florida, United States

Site Status

West Coast Endoscopy Center

Clearwater, Florida, United States

Site Status

Gastro Florida

Clearwater, Florida, United States

Site Status

UF Health Jacksonville - Gastroenterology Emerson

Jacksonville, Florida, United States

Site Status

Millenia Surgery Center

Orlando, Florida, United States

Site Status

HMD Research LLC

Orlando, Florida, United States

Site Status

Treasure Valley Medical Research

Boise, Idaho, United States

Site Status

WestGlen Gastrointestinal Consultants, P.A.

Shawnee Mission, Kansas, United States

Site Status

Chevy Chase Endoscopy Center

Chevy Chase, Maryland, United States

Site Status

MGG Group Co., Inc., Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Site Status

Capitol Research

Rockville, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Mass Eye and Ear, Longwood

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Site Status

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Site Status