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Trial record 1 of 1 for:    7981005 | ulcerative colitis
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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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ClinicalTrials.gov Identifier: NCT02958865
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: PF-06651600 or Placebo Drug: PF-06700841 or Placebo Drug: PF-06700841 Drug: PF-06651600 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : December 6, 2020
Estimated Study Completion Date : June 19, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06651600 Drug Dose Level 1
Delivered orally for 8 weeks
Drug: PF-06651600 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06651600 Drug Dose Level 2
Delivered orally for 8 weeks
Drug: PF-06651600 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06651600 Drug Dose Level 3
Delivered orally for 8 weeks.
Drug: PF-06651600 or Placebo
Delivered orally for 8 weeks.

Placebo Comparator: PF-06651600 Placebo
Delivered orally for 8 weeks.
Drug: PF-06651600 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06700841 Drug Dose Level 1
Delivered orally for 8 weeks
Drug: PF-06700841 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06700841 Drug Dose Level 2
Delivered orally for 8 weeks.
Drug: PF-06700841 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06700841 Drug Dose Level 3
Delivered orally for 8 weeks.
Drug: PF-06700841 or Placebo
Delivered orally for 8 weeks.

Placebo Comparator: PF-06700841 Placebo
Delivered orally for 8 weeks.
Drug: PF-06700841 or Placebo
Delivered orally for 8 weeks.

Experimental: PF-06651600 Drug Dose Level 4
Delivered orally for 24 weeks.
Drug: PF-06651600
Delivered orally for 24 weeks.

Experimental: PF-06700841 Drug Dose Level 4
Delivered orally for 24 weeks.
Drug: PF-06700841
Delivered orally for 24 weeks.




Primary Outcome Measures :
  1. Change from baseline in Total Mayo Score [ Time Frame: Baseline and Week 8 ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving remission based on total Mayo score [ Time Frame: Week 8 ]
    Remission excludes friability and is based on total Mayo score of less than/equal to 2 with no individual subscore greater than 1 at Week 8.

  2. Proportion of subjects in remission based on total Mayo score [ Time Frame: Week 32 ]
    Remission excludes friability and is based on total Mayo score of less than/equal to 2 with no individual subscore greater than 1 at week 32.

  3. Proportion of subjects achieving improvement in endoscopic appearance [ Time Frame: Week 8 and 32 ]
    Improvement of endoscopic appearance is defined as a Mayo endoscopic subscore of less than/equal to 1

  4. Proportion of subjects achieving clinical response [ Time Frame: Week 8 ]
    Clinical response is defined as a decrease from baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.

  5. Proportion of subjects in endoscopic remission [ Time Frame: Week 8 ]
    Endoscopic remission is defined as an endoscopic subscore of 0.

  6. Proportion of subjects in symptomatic remission [ Time Frame: Week 8 ]
    Symptomatic remission is defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and both rectal bleeding and stool frequency subscores of 0.

  7. Proportion of subjects achieving deep remission [ Time Frame: Week 8 ]
    Deep remission is defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a 0 on both endoscopic and rectal bleeding subscores.

  8. Partial Mayo Scores and changes from baseline [ Time Frame: Weeks 2, 4 and 8 ]
  9. Change from baseline in total Mayo score [ Time Frame: Week 8 ]
  10. Change from baseline in total Mayo score [ Time Frame: Week 32 ]
  11. Scores and changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score and domains [ Time Frame: Weeks 4 and 8 ]
    IBDQ domains include Bowel Symptoms, Systemic Symptoms, Emotional Function and Social Function.

  12. Proportion of subjects with IBDQ total score greater than/equal to 170. [ Time Frame: Weeks 4 and 8 ]
  13. Proportion of subjects with greater than/equal to 16 point increase in IBDQ total score from baseline [ Time Frame: Weeks 4 and 8 ]
  14. Proportion of subjects with improvement in IBDQ bowel symptom domain [ Time Frame: Weeks 4 and 8 ]
    Improvement is defined as an increase of at least 1.2 points from baseline in average score among IBDQ bowel symptom domain (items 1, 5, 9, 13, 17, 20, 22, 24, 26, 29).

  15. Scores and changes from baseline in SF-36 v2 [ Time Frame: Weeks 4 and 8 ]
    SF-36 physical and mental component summary scores: PCS and MCS, and 8 domain scores.

  16. Scores and changes from baseline in EuroQoL-5 Dimensions [ Time Frame: Weeks 4 and 8 ]
  17. Incidence of serious infections [ Time Frame: Baseline through week 36 ]
    Serious infections are treated infections that require parenteral antimicrobial therapy and present with positive pre-treatment culture AND EITHER require hospitalization for treatment OR meet other criteria that require the infection to be classified as an SAE.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ulcerative colitis for greater than/equal to 3 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958865


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 224 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02958865     History of Changes
Other Study ID Numbers: B7981005
VIBRATO ( Other Identifier: Alias Study Number )
2016-003708-29 ( EudraCT Number )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
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/data_requests

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Mayo score

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases