Status:
COMPLETED
Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
Lead Sponsor:
Pfizer
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 dai...
Eligibility Criteria
Inclusion
- 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
- 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.
- 14\) Subjects with history of thrombotic event(s), including deep venous thrombosis (DVT), and known inherited conditions that predispose to hypercoagulability.
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2023
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT03395184
Start Date
February 2 2018
End Date
October 19 2023
Last Update
October 30 2024
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