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

NCT02840721

Study Description

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of PF-06480605 in subjects with moderate to severe ulcerative colitis.

Interventional
B7541002
NCT02840721
Recruiting
October, 2016
November, 2018

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Criteria

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
  • 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:

  • 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.
Both
18 Years - 75 Years
No
United States
Recruiting
Surgery Center of Aventura
Aventura, Florida, United States, 33180
Recruiting
Venture Ambulatory Surgical Center
North Miami Beach, Florida, United States, 33162
Recruiting
FQL Research, LLC
Pembroke Pines, Florida, United States, 33027
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Recruiting
Commonwealth Clinical Studies
Brockton, Massachusetts, United States, 02302
Recruiting
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Recruiting
Commonwealth Endoscopy Center
West Bridgewater, Massachusetts, United States, 02379
Recruiting
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Recruiting
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, United States, 11021
Recruiting
The New York Presbyterian Hospital
New York, New York, United States, 10021
Recruiting
Weill Cornell Medicine
New York, New York, United States, 10021
Recruiting
The New York Presbyterian Hospital (Investigational Pharmacy-Drug Shipment)
New York, New York, United States, 10065
Recruiting
Weill Cornell Medical College
New York, New York, United States, 10065
Not yet recruiting
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, United States, 12601
Recruiting
Vanderbilt University Medical Center, IBD Clinic
Nashville, Tennessee, United States, 37212-1375
Recruiting
Vanderbilt University Medical Center - GI Research Office (Administrative Only)
Nashville, Tennessee, United States, 37212-1610
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-5543
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-7610
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Recruiting
Allegiance Research Specialists, LLC
Wauwatosa, Wisconsin, United States, 53226
Recruiting
GI Associates
Wauwatosa, Wisconsin, United States, 53226
Belgium
Recruiting
UZ Leuven (University Hospital Leuven) - Pharmacy Clinical Trials
Leuven, Belgium, 3000
Recruiting
UZ Leuven (University Hospital Leuven) - Radiology Department
Leuven, Belgium, 3000
Recruiting
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
Leuven, Belgium, 3000
France
Not yet recruiting
Hopital Huriez - CHRU de Lille
Lille Cedex, France, 59037
Not yet recruiting
Hopital de l'Archet 2
NICE Cedex 03, France, 06202
Not yet recruiting
Hopital Nord, Service Gastro-Enterologie-Hepatologie
Sanit Preisten Jarez, France, 42270
Italy
Recruiting
AOU Mater Domini - Univ."Magna Graecia" di Catanzaro - Campus Venuta - U.O Fisiopatologia Digestiva
Catanzaro, CZ, Italy, 88100
Recruiting
ISTITUTO CLINICO HUMANITAS Sezione Autonoma di Malattie Inflammatorie Croniche Intestinali
Rozzano, Milan (mi), Italy, 20089
Recruiting
Policlinico Universitario Campus Biomedico
Roma, RM, Italy, 00128
Korea, Republic of
Not yet recruiting
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Not yet recruiting
Hanyang University Guri Hospital
Gyeonggi-do, Korea, Republic of, 11923
Recruiting
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Not yet recruiting
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Not yet recruiting
Asan Medical Center
Seoul, Korea, Republic of, 05505
Netherlands
Not yet recruiting
Academic Medical Center, Apotheek-Kenniscentrum Geneesmiddelenonderzoek
Amsterdam, North Holland, Netherlands, 1105 AZ
Not yet recruiting
Academic Medical Centre, Department of Radiology
Amsterdam, North Holland, Netherlands, 1105 AZ
Not yet recruiting
Academic Medical Centre, Dept. of Gastroenterology
Amsterdam, North Holland, Netherlands, 1105 AZ
Poland
Recruiting
SPZOZ WSzZ im. Jedrzeja. Sniadeckiego W Bialymstoku Oddzial Chorob Wewnetrznych i Gastroenterologii
Bialystok, Poland, 15-950
Recruiting
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych Szpital Uniwersytecki nr 2 im Jana Biziela
Bydgoszcz, Poland, 85-168
Not yet recruiting
Gabinet Lekarski Janusz Rudzinski
Bydgoszcz, Poland, 85-681
Recruiting
Piotr Walczak Gabinet Endoskopii Przewodu Pokarmowego
Krakow, Poland, 31-009
Not yet recruiting
SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia
Lodz, Poland, 90-302
Recruiting
Endoskopia Sp. z.o.o.
Sopot, Poland, 81-756
Not yet recruiting
Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz
Warszawa, Poland, 03-580