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Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

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NCT02958865

Last updated on April 7, 2018
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FOR MORE INFORMATION
Study Location
Del Sol Research Managment, LLC
Tucson, Arizona, 85710 United States
See other locations
Contact
1-800-718-1021
[email protected]
Downloads
Related Links
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+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of ulcerative colitis for greater than/equal to 4 months.

- Moderate to severe active ulcerative colitis

- Inadequate response to, loss of response to, or intolerance to at least one
conventional therapy for UC.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pregnant or breastfeeding

- Clinical findings suggestive of Crohn's Disease

- History of bowel surgery within 6 months

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
Duration
The time commitment for participation in the study.
Screening: Up to 6 weeks
Follow up: 4 weeks
Treatment: 32 weeks
Site Visits
Screening: Up to 2 visits
Follow up: 1 visits
Treatment: 9 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Questionnaire
Keeping a diary
Stool test
Physical examination
Electrocardiogram (ECG)
Biopsy
Urine test
Colonoscopy
Vital signs and measurements
X-rays
NCT02958865
Pfizer
Recruiting
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

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Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
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 Subjects With Moderate To Severe Ulcerative Colitis
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: PF-06651600 or Placebo
    Delivered orally for 8 weeks.
  • Drug: PF-06700841 or Placebo
    Delivered orally for 8 weeks.
  • Drug: PF-06700841 or Placebo
    Delivered orally for 24 weeks.
  • Drug: PF-06651600 or Placebo
    Delivered orally for 24 weeks.
  • Experimental: PF-06651600 Drug Dose Level 1
    Delivered orally for 8 weeks
    Intervention: Drug: PF-06651600 or Placebo
  • Experimental: PF-06651600 Drug Dose Level 2
    Delivered orally for 8 weeks
    Intervention: Drug: PF-06651600 or Placebo
  • Experimental: PF-06651600 Drug Dose Level 3
    Delivered orally for 8 weeks.
    Intervention: Drug: PF-06651600 or Placebo
  • Placebo Comparator: PF-06651600 Placebo
    Delivered orally for 8 weeks.
    Intervention: Drug: PF-06651600 or Placebo
  • Experimental: PF-06700841 Drug Dose Level 1
    Delivered orally for 8 weeks
    Intervention: Drug: PF-06700841 or Placebo
  • Experimental: PF-06700841 Drug Dose Level 2
    Delivered orally for 8 weeks.
    Intervention: Drug: PF-06700841 or Placebo
  • Experimental: PF-06700841 Drug Dose Level 3
    Delivered orally for 8 weeks.
    Intervention: Drug: PF-06700841 or Placebo
  • Placebo Comparator: PF-06700841 Placebo
    Delivered orally for 8 weeks.
    Intervention: Drug: PF-06700841 or Placebo
  • Experimental: PF-06651600 Drug Dose Level 4
    Delivered orally for 24 weeks.
    Intervention: Drug: PF-06651600 or Placebo
  • Experimental: PF-06700841 Drug Dose Level 4
    Delivered orally for 24 weeks.
    Intervention: Drug: PF-06700841 or Placebo
  • Placebo Comparator: PF-06651600 Placebo 2
    Delivered orally for 24 weeks.
    Intervention: Drug: PF-06651600 or Placebo
  • Placebo Comparator: PF-06700841 Placebo 2
    Delivered orally for 24 weeks.
    Intervention: Drug: PF-06700841 or Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
January 28, 2020
July 12, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of ulcerative colitis for greater than/equal to 4 months.
  • Moderate to severe active ulcerative colitis
  • Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Clinical findings suggestive of Crohn's Disease
  • History of bowel surgery within 6 months
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Canada,   Denmark,   Germany,   Hungary,   Italy,   Korea, Republic of,   Poland,   Serbia,   Slovakia,   Spain,   Turkey,   Ukraine,   United States
 
 
NCT02958865
B7981005
VIBRATO ( Other Identifier: Alias Study Number )
2016-003708-29 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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