A Clinical Study of PF-06480605 for the Treatment of Moderate to Severe Ulcerative Colitis. (TUSCANY, B7541002)
NCT02840721
Last updated date
ABOUT THIS STUDY

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of PF-06480605 in subjects with moderate to severe ulcerative colitis.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Ulcerative Colitis
Sex
Females and Males
Age
18-75 years
Inclusion Criteria
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- Male or female subjects between ≥ 18 and ≤ 75 years of age at the time of informed consent
- Male subjects able to father children and female subjects of childbearing potential must agree to use two highly effective methods of contraception throughout the study and until the Week 26 visit
- Diagnosis of ulcerative colitis (UC) for ≥ 4 months
- Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for ulcerative colitis such as: Steroids; Immunosuppressants (AZA, 6-MP, or MTX); Anti TNF inhibitors (eg, infliximab, adalimumab, or golimumab); Anti-integrin inhibitors (eg, vedolizumab).
- Subjects currently receiving the following treatment are eligible provided they have been on stable doses of Oral 5
- ADA or sulfasalazine for at least 4 weeks prior to baseline; oral corticosteroids stable dose for at least 2 weeks prior to baseline; 6-MP or AZA stable dose for 8 weeks prior to baseline.
Exclusion Criteria
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Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or Crohn's Disease. Subjects with clinical findings suggestive of Crohn's disease (eg, fistulae, granulomas on biopsy) are also excluded.- Subjects with colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known colonic stricture, history of colonic or small bowel stoma, history of colonic or small bowel obstruction or resection
- Known history of HIV based on documented history with positive serological test, or positive HIV serologic test at screening
- Presence of a transplanted organ
- Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence);
- Acute coronary syndrome (eg., myocardial infarction, unstable angina pectoris); - Any history of cerebrovascular disease within 24 weeks before screening;
- Class III or Class IV heart failure
- Prior evidence of liver injury or toxicity due to methotrexate
- Subjects receiving the following therapies within the designated time period:
- > 9 mg/day of oral budesonide or >20 mg/day prednisone or equivalent 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
- Biologics including anti-TNF inhibitors as described: Infliximab, Adalimumab, or Golimumab within 8 weeks prior to baseline
- Anti-integrin inhibitors (eg, vedolizumab) within 12 weeks prior to baseline
- Other investigational procedures or products, or live attenuated vaccine within 30 days prior to baseline.
- Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse.
Trial Details
Administration
Intravenous injections
Placebo
A placebo is not used in this trial
Duration
Follow up: 3 months
Screening: Up to 6 weeks
Treatment: 12 weeks
Site Visits
Follow up: 5 visits
Screening: Up to 2 visits
Treatment: 7 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Keeping a diary
Stool test
Physical examination
Electrocardiogram (ECG)
Biopsy
Urine test
Blood test
Colonoscopy
Vital signs and measurements
X-rays
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Advanced Information
Descriptive Information | |||||||
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Brief Title ICMJE | Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis. | ||||||
Official Title ICMJE | A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN- LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | ||||||
Brief Summary | The purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis. | ||||||
Detailed Description | This is a Phase 2a, single arm, two-stage study in subjects with moderate to severe ulcerative colitis. Subjects will receive 500 mg of PF-06480605 intravenously every 2 weeks for a total of 7 doses. Blood, stool, and tissue samples will be collected at various time points throughout the study to evaluate safety, tolerability, efficacy, pharmacokinetics, and immunogenicity. Duration of participation for subjects will be approximately 8 months. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Colitis, Ulcerative | ||||||
Intervention ICMJE | Drug: PF-06480605
PF-06480605 500 mg IV Q2W x 7 Doses | ||||||
Study Arms ICMJE | Experimental: PF-06480605
PF-06480605 500 mg IV Q2W X 7 doses Intervention: Drug: PF-06480605 | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 50 | ||||||
Original Estimated Enrollment ICMJE | 40 | ||||||
Actual Study Completion Date ICMJE | August 30, 2018 | ||||||
Actual Primary Completion Date | May 31, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium, Italy, Korea, Republic of, Netherlands, Poland, United States | ||||||
Removed Location Countries | France | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02840721 | ||||||
Other Study ID Numbers ICMJE | B7541002 TUSCANY ( Other Identifier: Alias Study Number ) 2016-001158-16 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | May 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |