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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03269695
Date of registration: 30/08/2017
Prospective Registration: Yes
Primary sponsor: Pfizer
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)
Date of first enrolment: December 20, 2017
Target sample size: 20
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03269695
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2
Countries of recruitment
Australia Belgium Germany Israel Italy Korea, Republic of Saudi Arabia Serbia
Spain Turkey United States
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion criteria

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

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ulcerative Colitis
Intervention(s)
Drug: PF-06687234
Drug: Placebo
Primary Outcome(s)
Proportion of subjects in Clinical Remission [Time Frame: Week 12]
Secondary Outcome(s)
Incidence of the development of HAFAs and Nabs against PF 06687234. [Time Frame: Baseline through Week 16]
Mean change from baseline at Week 12 in Geboes histology score [Time Frame: Baseline, Week 12]
Proportion of subjects with a clinical response [Time Frame: Week 12]
Proportion of subjects with change from baseline in partial Mayo Score of 2 or less with no individual subscore >1 [Time Frame: Weeks 2, 4, 6, 8, 12]
Proportion of subjects with endoscopic improvement [Time Frame: Week 12]
Serum concentrations of PF 06687234 [Time Frame: Baseline through Week 12]
Secondary ID(s)
2017-002108-28
B7581002
BUILD UC
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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