Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.

• Register: ClinicalTrials.gov
• Last refreshed on: 30 October 2023
• Main ID: NCT02840721
• Date of registration: 27/06/2016
• Prospective Registration: Yes
• Primary sponsor: Telavant, Inc.
• Public title: Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.
• Scientific title: A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN- LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
• Date of first enrolment: October 26, 2016
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02840721
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, France, Italy, Korea, Republic of, Netherlands, Poland, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects between = 18 and = 75 years of age at the time of informed
consent

- Male subjects able to father children and female subjects of childbearing potential
must agree to use two highly effective methods of contraception throughout the study
and until the Week 26 visit

- Diagnosis of ulcerative colitis for = 4 months

- Subjects with moderate to severe active ulcerative colitis as defined by screening
colonoscopy with total Mayo score of = 6, with rectal bleeding subscore of = 1, and an
endoscopic subscore of = 2 on the Mayo

- Active disease beyond the rectum (> 15 cm of active disease at the screening
colonoscopy)

- Must have inadequate response to, loss of response to, or intolerance to at least one
conventional therapy for ulcerative colitis such as: Steroids; Immunosuppressants
(AZA, 6-MP, or MTX); Anti -TNF inhibitors (eg, infliximab, adalimumab, or golimumab);
Anti-integrin inhibitors (eg, vedolizumab).

- Subjects currently receiving the following treatment are eligible provided they have
been on stable doses of Oral 5-ASA or sulfasalazine for at least 4 weeks prior to
baseline; oral corticosteroids stable dose for at least 2 weeks prior to baseline;
6-MP or AZA stable dose for 8 weeks prior to baseline.

Exclusion Criteria:

- Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular
disease associated with colitis, microscopic colitis or Crohn's Disease. Subjects with
clinical findings suggestive of Crohn's disease (eg, fistulae, granulomas on biopsy)
are also excluded.

- Subjects with colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing
cholangitis, known colonic stricture, history of colonic or small bowel stoma, history
of colonic or small bowel obstruction or resection

- Presence of active enteric infections (positive stool culture and sensitivity)

- Known history of HIV based on documented history with positive serological test, or
positive HIV serologic test at screening

- Presence of a transplanted organ

- Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
(other than resected cutaneous basal cell or squamous cell carcinoma that has been
treated with no evidence of recurrence);

- Acute coronary syndrome (eg., myocardial infarction, unstable angina pectoris);

- Any history of cerebrovascular disease within 24 weeks before screening;

- Subject with current or a history of QT prolongation

- Class III or Class IV heart failure

- Prior evidence of liver injury or toxicity due to methotrexate

- Abnormality in hematology and/or chemistry profiles during screening (as detailed in
the protocol)

- Subjects receiving the following therapies within the designated time period:

- > 9 mg/day of oral budesonide or >20 mg/day prednisone or equivalent within 2
weeks prior to baseline

- IV, IM (parenteral), or topical (rectal) treatment of 5-ASA or corticosteroid
enemas/suppositories within 2 weeks prior to baseline

- Biologics including anti-TNF inhibitors as described: Infliximab, Adalimumab, or
Golimumab within 8 weeks prior to baseline

- Anti-integrin inhibitors (eg, vedolizumab) within 12 weeks prior to baseline

- Other investigational procedures or products, or live attenuated vaccine within
30 days prior to baseline.

- Current or history (within 2 years) of serious psychiatric disease or alcohol or drug
abuse



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: PF-06480605

Primary Outcome(s)

Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Who Withdrew Due to Adverse Events [Time Frame: Day 1 up to final onsite visit (Week 26)]

Percentage of Participants Achieving Endoscopic Improvement at Week 14, Based on Uniformly Minimum-Variance Unbiased Estimator (UMVUE) - Per Protocol Analysis Set [Time Frame: Week 14]

Number of Participants With Laboratory Abnormalities [Time Frame: Day 1 up to final onsite visit (Week 26)]

Number of Participants With Vital Signs Data Meeting Pre-specified Criteria [Time Frame: Baseline up to final onsite visit (Week 26)]

Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria [Time Frame: Baseline up to final onsite visit (Week 26)]

Secondary Outcome(s)

Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A) [Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, and 26]

Area Under the Concentration-time Profile From Time Zero to Time Tau (AUCtau) of PF-06480605 [Time Frame: 30 minutes pre-dose and 1 hour post-dose on Day 85]

Change From Baseline in Fecal Calprotectin [Time Frame: Baseline, Weeks 2, 8, 12 and 26]

Change From Baseline in High Sensitivity C-reactive Protein (HsCRP) [Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, and 26]

Percentage of Participants Achieving Remission at Week 14 - Full Analysis Set [Time Frame: Week 14]

Percentage of Participants Achieving Endoscopic Remission at Week 14 - Full Analysis Set [Time Frame: Week 14]

Percentage of Participants Achieving Remission at Week 14 - Per Protocol Analysis Set [Time Frame: Week 14]

Average Serum Concentration (Cav) of PF-06480605 [Time Frame: 30 minutes pre-dose and 1 hour post-dose on Day 85]

Lowest Serum Concentration (Cmin) of PF-06480605 [Time Frame: 30 minutes pre-dose and 1 hour post-dose on Day 85]

Percentage of Participants Who Developed Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) [Time Frame: Day 1 up to final onsite visit (Week 26)]

Maximum Serum Concentration (Cmax) of PF-06480605 [Time Frame: 30 minutes pre-dose and 1 hour post-dose on Day 85]

Secondary ID(s)

2016-001158-16

B7541002

TUSCANY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer

Results

• Results available: Yes
• Date Posted: 19/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02840721