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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2022
  • participants needed
    250
  • sponsor
    Pfizer
Updated on 24 May 2021
Investigator
Pfizer CT.gov Call Center
Primary Contact
Millenia Surgery Center (7.2 mi away) Contact
+296 other location
antibiotic therapy
antibiotics
corticosteroids
methotrexate
prednisone
adalimumab
ustekinumab
immunosuppressive agents
infliximab
abdominal pain
tumor necrosis factor
mercaptopurine
budesonide
conventional treatment
vedolizumab
crohn's disease
azathioprine
sulfasalazine
certolizumab pegol
mesalamine
ileal disease

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.

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment PF-06700841, PF-06651600, Placebo PF-06651600, Placebo PF-06700841
Clinical Study IdentifierNCT03395184
SponsorPfizer
Last Modified on24 May 2021

Eligibility

Yes No Not Sure

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
>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
Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline
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
Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline
Ustekinumab within 8 weeks prior to baseline
Interferon therapy within 8 weeks prior to baseline
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)
Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline
Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline
Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline
Subjects who have received other JAK inhibitors within 3 months prior to baseline
Subjects who have not responded to or have been intolerant of other JAK inhibitors
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
Subjects with history of thrombotic event(s), including deep venous thrombosis (DVT), and known inherited conditions that predispose to hypercoagulability
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