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A Clinical Study of PF-06480605 for the Treatment of Moderate to Severe Ulcerative Colitis. (TUSCANY, B7541002)

Last updated on October 9, 2019

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Study Location
Surgery Center of Aventura
Aventura, Florida, 33180 United States
Contact
1-800-718-1021
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
  • 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
  • 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
The form in which the study drug will be delivered to the patient's body.
Intravenous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
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
NCT02840721
Cheladv74
Completed
A Clinical Study of PF-06480605 for the Treatment of Moderate to Severe Ulcerative Colitis. (TUSCANY, B7541002)

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Descriptive Information
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 SummaryThe purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis.
Detailed DescriptionThis 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
 (submitted: February 25, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2016)
40
Actual Study Completion Date  ICMJE August 30, 2018
Actual Primary Completion DateMay 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 for ? 4 months
  • Subjects with moderate to severe active ulcerative colitis as defined by screening colonoscopy with total Mayo score of ? 6, with rectal bleeding subscore of ? 1, and an endoscopic subscore of ? 2 on the Mayo
  • Active disease beyond the rectum (> 15 cm of active disease at the screening colonoscopy)
  • 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-ASA 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:

  • 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
  • Presence of active enteric infections (positive stool culture and sensitivity)
  • 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;
  • Subject with current or a history of QT prolongation
  • Class III or Class IV heart failure
  • Prior evidence of liver injury or toxicity due to methotrexate
  • Abnormality in hematology and/or chemistry profiles during screening (as detailed in the protocol)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CountriesFrance
 
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 CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Cheladv74 will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Cheladv74's data sharing criteria and process for requesting access can be found at: http://cheladv74.ru/science/clinical_trials/trial_data_and_results/da....
URL:http://cheladv74.ru/science/clinical_trials/trial_data_and_results/da...
Responsible PartyCheladv74
Study Sponsor  ICMJE Cheladv74
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Cheladv74 CT.gov Call CenterCheladv74
PRS AccountCheladv74
Verification DateMay 2019

ICMJE     Data element required by the
and the

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