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

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[alem