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

NCT ID: NCT02840721

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-26
• Study Completion Date: 2018-08-30

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.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PF-06480605

PF-06480605 500 mg IV Q2W X 7 doses

Group Type: EXPERIMENTAL

PF-06480605

Intervention Type: DRUG

PF-06480605 500 mg IV Q2W x 7 Doses

Interventions

PF-06480605

PF-06480605 500 mg IV Q2W x 7 Doses

Intervention Type: DRUG

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Telavant, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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

Endoskopia Sp. z.o.o.

Sopot, , Poland

Kangbuk Samsung Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Countries

United States; Belgium; Italy; Netherlands; Poland; South Korea

References

Danese S, Klopocka M, Scherl EJ, Romatowski J, Allegretti JR, Peeva E, Vincent MS, Schoenbeck U, Ye Z, Hassan-Zahraee M, Rath N, Li G, Neelakantan S, Banfield C, Lepsy C, Chandra DE, Hung KE. Anti-TL1A Antibody PF-06480605 Safety and Efficacy for Ulcerative Colitis: A Phase 2a Single-Arm Study. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2324-2332.e6. doi: 10.1016/j.cgh.2021.06.011. Epub 2021 Jun 12.

Reference Type: DERIVED

PMID: 34126262 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B7541002

To obtain contact information for a study center near you, click here.

Other Identifiers

TUSCANY

Identifier Type: OTHER

Identifier Source: secondary_id

2016-001158-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7541002

Identifier Type: -

Identifier Source: org_study_id