Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 75 Years|
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).
- - 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.
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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Pfizer CT.gov Call Center|
|Principal Investigator Affiliation||Pfizer|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Croatia, Czechia, Georgia, Germany, Hungary, Italy, Korea, Republic of, Lebanon, Poland, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
Experimental: PF-06700841 or placebo
Experimental: PF-06651600 or placebo
Drug: - Placebo PF-06651600
12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks
Drug: - Placebo PF-06700841
12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.
Drug: - PF-06651600
200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks
Drug: - PF-06700841
60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.