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

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT03395184

Run by

Pfizer

People needed

244

Starts

2018-02-02

Expected to finish

2023-10-19

Last updated by the study team

2024-10-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Gut P.C., dba Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
• Brighton Surgical Center — Beverly Hills, California, United States
• Entertainment Medical Group — Los Angeles, California, United States
• Gastrointestinal Biosciences Clinical Trials, LLC — Los Angeles, California, United States
• Stanford Medicine Outpatient Center - Digestive Health Center — Redwood City, California, United States
• Front Range Endoscopy Center — Colorado Springs, Colorado, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Gastro Florida — Clearwater, Florida, United States
• Gastro Florida — Clearwater, Florida, United States
• West Coast Endoscopy Center — Clearwater, Florida, United States
• Gastro Florida — Clearwater, Florida, United States
• UF Health Jacksonville - Gastroenterology Emerson — Jacksonville, Florida, United States
• Millenia Surgery Center — Orlando, Florida, United States
• HMD Research LLC — Orlando, Florida, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• WestGlen Gastrointestinal Consultants, P.A. — Shawnee Mission, Kansas, United States
• Chevy Chase Endoscopy Center — Chevy Chase, Maryland, United States
• MGG Group Co., Inc., Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Capitol Research — Rockville, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Mass Eye and Ear, Longwood — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Eastside Endoscopy Center — Macomb, Michigan, United States
• Dothan Surgery Center — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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