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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03269695
Ethics application status
Date submitted
30/08/2017
Date registered
30/08/2017
Date last updated
3/01/2019

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

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

Placebo Comparator: Placebo - PF-06687234 Placebo SC QW x 12 doses


Treatment: Drugs: PF-06687234
SC QW

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

Outcomes
Primary outcome [1] 0 0
Proportion of subjects in Clinical Remission - Clinical remission defined by a modified Mayo Score with an endoscopic subscore less than or equal to 1, stool frequency subscore less than or equal to 1 and rectal bleeding subscore = 0
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of subjects with endoscopic improvement - Endoscopic improvement defined as decrease of 1 point in Mayo endoscopy score or an absolute endoscopy score of 1 or less.
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Mean change from baseline at Week 12 in Geboes histology score - Mean change from baseline at Week 12 in Geboes score.
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Proportion of subjects with a clinical response - Clinical response defined with a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one point decrease or absolute score of 0 or 1 in rectal bleeding subscore.
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Proportion of subjects with change from baseline in partial Mayo Score of 2 or less with no individual subscore >1 - Proportion of subjects with partial Mayo score <=2 with no individual subscore of > 1 at Week 2, 4, 6, 8 and 12
Timepoint [4] 0 0
Weeks 2, 4, 6, 8, 12
Secondary outcome [5] 0 0
Serum concentrations of PF 06687234 - Measure serum concentration of PF-06687234 at baseline, Week 1, 3, 7, 11, 12, and 16
Timepoint [5] 0 0
Baseline through Week 12
Secondary outcome [6] 0 0
Incidence of the development of HAFAs and Nabs against PF 06687234. - Measure HAFA and neutralizing antibody against IL10 at screen, baseline, Week 3, 7, 11, 12, and 16
Timepoint [6] 0 0
Baseline through Week 16

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Eastern Health-Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
St. Vincent's Hospital, Melbourne - Fitzroy
Recruitment hospital [5] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [7] 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
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment postcode(s) [7] 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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Belgium
State/province [12] 0 0
Liege
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg
Country [14] 0 0
Germany
State/province [14] 0 0
Kiel
Country [15] 0 0
Israel
State/province [15] 0 0
Ramat-Gan
Country [16] 0 0
Italy
State/province [16] 0 0
BO
Country [17] 0 0
Italy
State/province [17] 0 0
Milano
Country [18] 0 0
Italy
State/province [18] 0 0
Milan
Country [19] 0 0
Italy
State/province [19] 0 0
Modena
Country [20] 0 0
Italy
State/province [20] 0 0
Padova
Country [21] 0 0
Italy
State/province [21] 0 0
Rome
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Korea
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Busan
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Gyeonggi-do
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Seoul
Country [26] 0 0
Spain
State/province [26] 0 0
Guipuzcoa
Country [27] 0 0
Spain
State/province [27] 0 0
Sevilla
Country [28] 0 0
Spain
State/province [28] 0 0
Valencia

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if PF-06687234 is effective and safe as add-on
therapy to infliximab in subjects with active ulcerative colitis who are not in remission.
Trial website
https://clinicaltrials.gov/show/NCT03269695
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
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable