Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.

Completed · Phase 2

Conditions studied: Colitis, Ulcerative

In brief

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

Key facts

Study ID: NCT02840721
Run by: Telavant, Inc.
People needed: 50
Starts: 2016-10-26
Expected to finish: 2018-08-30
Last updated by the study team: 2023-10-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Surgery Center of Aventura — Aventura, Florida, United States
Venture Ambulatory Surgical Center — North Miami Beach, Florida, United States
FQL Research, LLC — Pembroke Pines, Florida, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
NYU Langone Long Island Clinical Research Associates — Great Neck, New York, United States
NYU Langone Nassau Gastroenterology Associates — Great Neck, New York, United States
New York Presbyterian Hospital-Weill Cornell Medical College — New York, New York, United States
Weill Cornell Medical College — New York, New York, United States
Weill Cornell Medicine — New York, New York, United States
New York Presbyterian Hospital — New York, New York, United States
Allegiance Research Specialists, LLC — Wauwatosa, Wisconsin, United States
UZ Leuven (University Hospital Leuven) - Pharmacy Clinical Trials — Leuven, Belgium
UZ Leuven (University Hospital Leuven) - Radiology Department — Leuven, Belgium
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg — Leuven, Belgium
AOU Mater Domini - Univ."Magna Graecia" di Catanzaro - Campus Venuta - U.O Fisiopatologia Digestiva — Catanzaro, CZ, Italy
ISTITUTO CLINICO HUMANITAS Sezione Autonoma di Malattie Infiammatorie Croniche Intestinali — Rozzano, Milan (MI), Italy
Policlinico Universitario Campus Biomedico — Roma, RM, Italy
Academic Medical Center, Apotheek-Kenniscentrum Geneesmiddelenonderzoek — Amsterdam, North Holland, Netherlands
Academic Medical Centre, Department of Radiology — Amsterdam, North Holland, Netherlands
Academic Medical Centre, Dept. of Gastroenterology — Amsterdam, North Holland, Netherlands
SPZOZ WSzZ im. Jedrzeja. Sniadeckiego W Bialymstoku Oddzial Chorob Wewnetrznych i Gastroenterologii — Bialystok, Poland
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych Szpital Uniwersytecki nr 2 im Jana Biziela — Bydgoszcz, Poland
Piotr Walczak Gabinet Endoskopii Przewodu Pokarmowego — Krakow, Poland
SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia — Lodz, Poland

Full record on ClinicalTrials.gov

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