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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03269695




Registration number
NCT03269695
Ethics application status
Date submitted
30/08/2017
Date registered
1/09/2017

Titles & IDs
Public title
Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.
Scientific title
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)
Secondary ID [1] 0 0
2017-002108-28
Secondary ID [2] 0 0
B7581002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06687234
Treatment: Drugs - Placebo

Experimental: PF-06687234 - PF-06687234 subcutaneous (SC) weekly (QW) x 12 doses

Placebo comparator: Placebo - PF-06687234 matched Placebo SC QW x 12 doses


Treatment: Drugs: PF-06687234
SC QW

Treatment: Drugs: Placebo
SC QW
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants in Modified Clinical Remission at Week 12 (Traditional Endoscopic Subscore <=1, Observed Cases)
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Percentage of Participants in Modified Clinical Remission at Week 12 (Traditional Mayo Endoscopic Subscore <=1, Treatment Failure Approach)
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
Percentage of Participants in Modified Clinical Remission at Week 12 (Modified Mayo Endoscopy Subscore = 0 or 1, Observed Cases)
Timepoint [3] 0 0
Week 12
Primary outcome [4] 0 0
Percentage of Participants in Modified Clinical Remission at Week 12 (Modified Mayo Endoscopy Subscore = 0 or 1, Treatment Failure Approach)
Timepoint [4] 0 0
Week 12
Primary outcome [5] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities)
Timepoint [5] 0 0
Baseline (Day 1) through and including a minimum of 28 calendar days after the last administration of the investigational products (22 weeks in total)
Primary outcome [6] 0 0
Number of Participants With Treatment-Emergent AEs (Treatment Related)
Timepoint [6] 0 0
Baseline (Day 1) through and including a minimum of 28 calendar days after the last administration of the investigational products (22 weeks in total)
Primary outcome [7] 0 0
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Timepoint [7] 0 0
From baseline through Week 16
Primary outcome [8] 0 0
Number of Participants With Categorical Vital Signs
Timepoint [8] 0 0
From baseline through Week 16
Primary outcome [9] 0 0
Number of Participants With Categorical Electrocardiogram (ECG) Data
Timepoint [9] 0 0
From baseline through Week 16
Secondary outcome [1] 0 0
Percentage of Participants With Endoscopic Improvement at Week 12 ( Observed Cases)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants With Endoscopic Improvement at Week 12 ( Treatment Failure Approach)
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving Geboes Index Remission at Week 12 (Observed Cases)
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Change From Baseline in Robart's Histology Index at Week 12 (Observed Cases)
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants With a Clinical Response at Week 12 (Observed Cases)
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants With a Clinical Response at Week 12 (Treatment Failure Approach)
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Percentage of Participants With Change From Baseline in Derived Partial Mayo Score of <=2 With no Individual Subscore >1 at Weeks 2, 4, 8 and 12 (Observed Cases)
Timepoint [7] 0 0
Baseline, Weeks 2, 4, 8 and 12
Secondary outcome [8] 0 0
Serum Concentrations of PF-06687234 20 mg
Timepoint [8] 0 0
Prior to dosing on Day 1 and at Weeks 1, 3, 7, 11, 12 (168 hours post dose) and 16
Secondary outcome [9] 0 0
Percentage of Participants With the Development of Human Anti-Fusion Antibodies (HAFAs) and Neutralizing Antibodies (NAbs) Against PF-06687234
Timepoint [9] 0 0
At screening, Day 1, Weeks 3, 7, 11, 12 and 16 (prior to dosing)

Eligibility
Key inclusion criteria
* Male and/or female subjects 18 years to 75 years of age and weight > 40 kg at the time of informed consent.
* A diagnosis of active UC (histologic) for 4 months.
* Subjects with active UC as defined by (via screening endoscopy) a total Mayo Score of 4 or more but 9 or less and an endoscopic subscore of 2.or more.
* UC extending at least 15 cm proximal to the anal verge at the time of the screening endoscopy.
* Must be on a stable dose 5-10 mg/kg of Remicade, Inflectra, or Remsima for a minimum of 14 weeks with no anticipation of need for change in infliximab treatment regimen throughout the study
* Male subjects able to father children and female subjects of childbearing potential and at risk for pregnancy must agree to use two methods of contraception (at least one of which is considered as highly effective) throughout the study and until the Week 16 visit
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with a diagnosis or documented history of total colectomy and/or pouchitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, or clinical findings suggestive of Crohn's disease.
* Subjects need for surgery or with major elective surgery scheduled during the study.
* Subjects with extensive colitis for at least 8 years who have not had a colonoscopy with surveillance biopsies within 2 years prior to baseline.
* Subjects with history of or at screening endoscopy, biopsy documented colonic dysplasia or neoplasia.
* Subjects who require infliximab dosing interval other than every 6 weeks or every 8 weeks.
* Subjects displaying clinical signs of fulminant colitis or toxic megacolon, with primary sclerosing cholangitis, known colonic stricture, history of colonic, small bowel obstruction or resection, with history of or current colonic or small bowel stoma.
* Cyclic neutropenia, thrombocytopenia, lymphopenia, leukopenia or history of chronic anemia.
* Presence of active enteric infection.
* Known history of human immunodeficiency virus (HIV) based on documented history with positive serological test, or positive HIV serologic test.
* Presence of transplanted organ.
* Anticipated need for any live vaccine.
* Class III or Class IV heart failure.
* Acute coronary syndrome and any history of cerebrovascular disease.
* Subjects with current, or a history of QT prolongation.
* Subjects receiving the following therapies within the designated time period:

* >9 mg/day of oral budesonide or >20 mg/day of prednisone or equivalent within 2 weeks prior to baseline.
* IV, IM or topical (rectal) treatment of 5-ASA or corticosteroid enemas within 2 weeks prior to baseline.
* Anti integrin inhibitors within 14 weeks prior to baseline.
* Any use of natalizumab.
* Interferon therapy within 8 weeks prior to baseline.
* Prior treatment with lymphocyte depleting therapies and alkylating agents.
* Received selective B lymphocyte depleting agents within 1 year prior to baseline.
* Receiving leukocyte apheresis, granulocyte apheresis, or plasma exchange within 6 months of baseline.
* JAK inhibitors within 3 months prior to baseline.
* Any investigational procedures(s) or product(s)30 days prior to baseline.
* History of sensitivity to heparin or heparin induced thrombocytopenia
* Known history of hypersensitivity, intolerance, or allergic reaction to PF-06687234 or any constituent of the IP.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/01/2021
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Eastern Health-Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
St. Vincent's Hospital, Melbourne - Fitzroy
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [6] 0 0
St John Of God Health Care Inc. Trading as St. John of God Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Belgium
State/province [6] 0 0
Liege
Country [7] 0 0
Germany
State/province [7] 0 0
Kiel
Country [8] 0 0
Israel
State/province [8] 0 0
Ramat-Gan
Country [9] 0 0
Italy
State/province [9] 0 0
Milano
Country [10] 0 0
Italy
State/province [10] 0 0
Padova
Country [11] 0 0
Italy
State/province [11] 0 0
Roma
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Gyeonggi-do
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul
Country [14] 0 0
Saudi Arabia
State/province [14] 0 0
Jeddah
Country [15] 0 0
Saudi Arabia
State/province [15] 0 0
Riyadh
Country [16] 0 0
Serbia
State/province [16] 0 0
Belgrade
Country [17] 0 0
Turkey
State/province [17] 0 0
Mersin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03269695