A Study of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis

A phase 2B, multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics of PF-06480605 in adult participants with moderate to severe ulcerative colitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026827

Enrollment

240

Registered

2020-07-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K515- Left sided colitis Health Condition 2: K510- Ulcerative (chronic) pancolitis Health Condition 3: K512- Ulcerative (chronic) proctitis Health Condition 4: K513- Ulcerative (chronic) rectosigmoiditis

Interventions

Intervention1: PF 06480605: Doses of 50 mg, 150 mg, and 450 mg PF-06480605 or Placebo will be administered through 4 treatment arms in a 12-week induction phase. After the induction phase, doses of 50

Eligibility

Inclusion criteria

Inclusion criteria: (1) A diagnosis of UC for >=3 months. (2)Participants with moderate to severe active UC as defined by a Total Mayo Score of >=6, and an endoscopic subscore of >=2. (3)Active disease beyond the rectum ( >15 cm of active disease from the anal verge at the screening endoscopy). (4)Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.

Exclusion criteria

Exclusion criteria: (1)Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohns disease (eg, skip lesions, fistulae or perianal disease, non necrotizing granulomas, etc.). (2)Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study (3) Chest Radiograph showing abnormalities i.e. the study will accept a Chest x ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available. (4)12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (5)Infected with tuberculosis i.e. any evidence of untreated latent or active TB infection. (6)Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses

Design outcomes

Primary

Measure	Time frame
1. Proportion of participants achieving clinical remission (defined as a Total Mayo Score lesser than or equal to 2, with no individual subscore greater than 1) at Week 14. Safety and tolerability will also be assessed. 2.Incidence and severity of treatment emergent adverse events during the induction period. 3.Incidence of serious adverse events during the induction period. 4.Incidence of AEs or SAEs leading to discontinuation during the induction period.Timepoint: week 0-14	—

Measure

Time frame

1. Proportion of participants achieving clinical remission (defined as a Total Mayo Score lesser than or equal to 2, with no individual subscore greater than 1) at Week 14. Safety and tolerability will also be assessed. 2.Incidence and severity of treatment emergent adverse events during the induction period. 3.Incidence of serious adverse events during the induction period. 4.Incidence of AEs or SAEs leading to discontinuation during the induction period.Timepoint: week 0-14

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Secondary

Measure	Time frame
Proportion of participants achieving endoscopic remission (defined as endoscopic subscore equal to 0) at Week 14Timepoint: week 0-14;1.Proportion of participants achieving remission Food and Drug Administration, ((FDA) definition 1 - defined as endoscopic subscore equal to 0 or 1, stool frequency subscore equal to 0, and rectal bleeding subscore equal to 0) at Week 14.Timepoint: week 0-14;2.Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore equal to 0 or 1, greater than or equal to 1 point decrease from baseline to achieve a stool frequency subscore equal to 0 or 1, and rectal bleeding subscore equal to 0) at Week 14Timepoint: week 0-14;3.Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore equal to 0 or 1) at Week 14.Timepoint: week 0-14;5.PF 06480605 trough concentrations during the induction period through Week 14.Timepoint: week 0-14;6.Change from baseline in fecal calprotectin during the induction period through Week 14.Timepoint: week 0-14;7.Change from baseline in hsCRP during the induction period through Week 14.Timepoint: week 0-14;8.Change from baseline in serum sTL1A during the induction period through Week 14.Timepoint: week 0-14;9.Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14.Timepoint: week 0-14	—

Measure

Time frame

Proportion of participants achieving endoscopic remission (defined as endoscopic subscore equal to 0) at Week 14Timepoint: week 0-14;1.Proportion of participants achieving remission Food and Drug Administration, ((FDA) definition 1 - defined as endoscopic subscore equal to 0 or 1, stool frequency subscore equal to 0, and rectal bleeding subscore equal to 0) at Week 14.Timepoint: week 0-14;2.Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore equal to 0 or 1, greater than or equal to 1 point decrease from baseline to achieve a stool frequency subscore equal to 0 or 1, and rectal bleeding subscore equal to 0) at Week 14Timepoint: week 0-14;3.Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore equal to 0 or 1) at Week 14.Timepoint: week 0-14;5.PF 06480605 trough concentrations during the induction period through Week 14.Timepoint: week 0-14;6.Change from baseline in fecal calprotectin during the induction period through Week 14.Timepoint: week 0-14;7.Change from baseline in hsCRP during the induction period through Week 14.Timepoint: week 0-14;8.Change from baseline in serum sTL1A during the induction period through Week 14.Timepoint: week 0-14;9.Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14.Timepoint: week 0-14

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Countries

Australia, Austria, Belarus, Belgium, Bulgaria, China, Colombia, France, Germany, Hungary, India, Italy, Japan, Kazakhstan, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, United States of America

Contacts

Public ContactDr Seema Pai

Pfizer Limited

karan.thakkar@pfizer.com7045788858

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026