Vibrato Study B7981005: A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Patients with Moderate to Severe Ulcerative Colitis
Published: 11/02/2017
General Information:
Study Objective
The purpose of this research study is to compare the effects of the study drugs, PF-06651600 and PF-06700841, with placebo to find out which is better for treating UC. PF-06651600 and PF-06700841 are investigational drugs.
Phase of study
Phase 2
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Eligibility:
Age
Adult (18+)
Gender
Female
Male
Disease Type
ulcerative-colitis
Severity
Moderate
Severe
Eligibility Criteria
- Male or female patients between ≥ 18 and ≤ 70 years of age at the time of informed consent
- Diagnosis of ulcerative colitis for ≥ 4 months
- Male patients 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 follow-up visit at week 36.
- Patients 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).
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Study Details:
Study Description
- This is a Phase 2b randomized double-blind placebo controlled study in patients with moderate to severe UC. The study will be conducted at approximately 198 centers from 24 countries, and is expected to enroll approximately 360 patients.
- Enrolled patients will receive either PF-06651600, PF-06700841 or placebo.
- Participants who are enrolled in the PF-06651600 group will either receive 20, 70 or 200 mg of study drug daily or matching placebo.
- Participants who are enrolled in to the PF-06700841 group you will receive either 10, 30, or 60 mg daily of the study drug or a matching placebo.
- Following the 8 week induction period of the study, all participants, including those on placebo, will be re-assigned to the chronic therapy period (24 weeks) of the study.
- Participants originally in the group receiving PF-06651600 will either receive 50 mg of the study drug or matching placebo.
- Participants originally in the group receiving PF-06700841 will either receive 30 mg of the study drug or placebo.
Description of Treatment or Intervention (Mechanism of Action)
- PF-06651600 and PF-06700841 are investigational drugs. PF-06651600 is in a class called JAK3 inhibitors, which could be helpful in treating UC. PF-06700841 is in a class called TYK2 and JAK1 which together could be helpful in treating UC. PF-06651600 and PF-06700841 may decrease the inflammation and ulceration of Ulcerative Colitis by inhibiting production of cytokines (small proteins) which are thought to be key drivers of the disease.
- PF-06651600, PF-06700841 or placebo will be taken as oral tablets.
Patient Participation Requirements
- Eligible patients will have at least 11 site visits. The duration of participation of eligible patients will be approximately 10 months (42 weeks).
- Written informed consent must be obtained prior to performance of any protocol-specific procedures. Patients will be screened to confirm that they meet all inclusion/exclusion criteria for the study.
- Screening procedures include: complete medical history, medication history, ECG, and prior treatment for ulcerative colitis. A complete physical examination will be performed including collection of blood, urine, and stool samples. Women of childbearing potential will be tested for pregnancy and will need to adhere to strict contraception requirements throughout the study. You will have a chest X-ray, if you have not had one in the last 12 weeks. A screening endoscopy (flexible sigmoidoscopy or colonoscopy) will be performed.
- During the treatment period, blood and stool samples will be collected periodically for safety, effectiveness, and exploratory assessments. An additional endoscopy will be performed at week 8 and at week 32, after which participants will enter the follow-up period.
- Participants will be required to keep an electronic diary beginning with the first screening visit and ending at the final study visit. Participants will record information daily on their stool frequency and rectal bleeding. There will be quality of life questionnaires to complete throughout the study.
Possible Risks & Side Effects
- PF-06651600 (Study Drug): may cause diarrhea, headache and erythema. May cause rashes or infections.
- PF-06700841 (Study Drug): may cause headache, constipation. May cause infections.
- At this time, the effects of PF-06700841 on male and female fertility, and pregnancy in humans, and effects on fetus or a nursing child are not known. For this reason strict use of birth control must be followed.
- Both PF-06651600 and PF-06700841 are investigational, so there may be other risks that are unknown.
Placebo Risk:
- Certain research participants in this research study will receive a placebo. Taking a placebo may be similar to not taking any medication. If you are one of the people who receive a placebo, your UC may stay the same or get worse, or your UC may suddenly get better just as it may have done without additional treatment.
Risks related to study procedures:
- Blood draws: A blood draw may cause faintness, inflammation of the vein, pain, bruising, or bleeding at the site of puncture.
- ECG: The risks from an ECG can include skin irritation and a rash from the gel that is used or from wearing or removing the patches.
- Hearing test (audiogram): no risks associated with having an audiogram.
- Chest X-ray: The amount of radiation from a chest x-ray will be about 0.1 millisievert (mSv). There is no significant risk from this total amount of radiation.
- Endoscopy (Flexible Sigmoidoscopy and Colonoscopy): Complications of this procedure are very uncommon and may include bleeding and perforation (tear or hole in the bowel).
- Tissue biopsies: Small pinches of tissue from the intestine will be taken during endoscopy and may cause potential minor bleeding. You will not feel any pain from this.
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Contact Information:
Site Locations
MGG Group Co., Inc, Chevy Chase Clinical Research
5550 Friendship Boulevard, #T90
Chevy Chase,
Maryland 20815
Connecticut Clinical Research Foundation
41 Brewster Road
Bristol,
Connecticut 06010
Clinical Applications Laboratories, Inc.
3330 Third Avenue, Suite 303
San Diego,
California 92103
NYU Langone Long Island Clinical Research Associates
1000 Northern Blvd., Suite 160
Great Neck,
New York 11021
Gastro Center of Maryland
7120 Minstrel Way, Suite 100
Columbia,
Maryland 21045
Texas Digestive Disease Consultants-Department of Research and Education
2485 E. Southlake Blvd, Suite 100
Southlake,
Texas 76092
Northwell Health
600 Northern Blvd.
Suite 111
Great Neck,
New York 11021
Medical Associates Research Group
8008 Frost St, Suite 200
San Diego,
California 92123
Long Beach Clinical Trial Service, Inc.
2403 Atlantic Ave.
Long Beach,
California 90806
Suzanee Fussell
McGuire VA Medical Center
1201 Broad Rock Boulevard
Richmond,
Virginia 23249
Illinois Gastroenterology Group
1415 S. Arlington Heights Road
Arlington,
Illinois 60005
UT Southwestern Medical Center
5323 Harry Hines Boulevard
Dallas,
Texas 75390
Tasneem Ahmed
Umass Memorial Medical Center
55 Lake Avenue North, Room HA-151
Worcester,
Massachusetts 01655
New York Presbyterian Hospital-Weill Cornell Medical College
1315 York Ave. Mezzanine Level
New York,
New York 10021
Baylor College of Medicine
7200 Cambridge St. Suite A10. 194 BCM MS 901
Houston,
Texas 77030
Digestive Health Specilists of the Southeast
480 Honeysuckle Road
Dothan,
Alabama 36305
Massachusetts General Hospital-Crohn's and Colitis Center
165 Cambridge St., 9th Floor
Boston,
Massachusetts 02114
UC San Diego Health Systems
9444 Medical Center Drive
La Jolla,
California 92093
Brigham and Women's Hospital
75 Francis St
Boston,
Massachusetts 02114
University of North Carolina at Chapel Hill
130 Mason Farm Rd
Chapel Hill,
North Carolina 27517
Millie Long
Cro-Nola, LLC
1023 Wood Street
Houma,
Louisiana 70360
Advanced Research Institute, Inc.
7114 Congress Street
New Port Richey,
Florida 34653
Blue Ridge Medical Research
121 Nationwide Drive
Lynchburg,
Virginia 24502
Larry Clark
Capitol Research
10110 Molecular Drive
Rockville,
Maryland 20850
Ajay Bakhshi
Gastroenterology Associates of Northern Virginia
3028 Javier Road
Fairfax,
Virginia 22031
Gastroenterology Consultants of Clearwater
508 Jeffords Street
Clearwater,
Florida 33756
Howard Klein
HRMD Research
5520 Landon B Johnson Freeway
Dallas,
Texas 75240
Aamar Agha
Metropolitan Gastroenterology Group, PC- Chevy Chase Clinical Research
5550 Friendship Boulevard
Chevy Chase,
Maryland 20815
Faryal Mirza
Peak Gastroenterology Associates
2920 North Cascade Avenue
Colorado Springs,
Colorado 80907
San Antonio Gastroenterology Associates Clinical Trials (SAGACT)
2833 Babcock Rd
San Antonio,
Texas 78229
Southern California Research institute Medical Group, Inc./West Gastroenterolgy Medical Group/Airport Endoscopy Center
8110 Airport Boulevard
Los Angeles,
California 90045
Adebambo Ojuri
Southwest Gastroenterology
9921 Southwest Highway
Oak Lawn,
Illinois 60453
Digestive Disease Specialists Inc. (DDSI)
3366 NW Expressway
Building D
Oklahoma City,
Oklahoma 73112
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