A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis

NCT04090411

Last updated date
Study Location
AKH Wien, Universitätsklinik für Innere Medizin III
Wien, , A-1090, Austria
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Moderate to Severe Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

-

- A diagnosis of UC for ≥3 months.

- Participants with moderate to severe active UC as defined by a Total Mayo Score of

≥6, and an endoscopic subscore of ≥2.

- Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Participants with a diagnosis of ischemic colitis, infectious colitis, radiation
colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's
disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas,
etc.).


- Participants with an imminent need for surgery or with elective surgery scheduled to
occur during the study


- Chest Radiograph showing abnormalities: 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.


- 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities
that may affect participant safety or interpretation of study results


- Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB
infection.


- Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses

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Moderate to Severe Ulcerative ColitisA Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis
NCT04090411
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis
Official Title  ICMJE 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
Brief Summary This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Ulcerative Colitis
Intervention  ICMJE
  • Drug: 50 mg
    PF-06480605
  • Drug: 450 mg
    PF-06480605
  • Drug: 150 mg
    PF-06480605
  • Other: 0 mg
    0 mg Placebo
Study Arms  ICMJE
  • Experimental: 450 mg
    PF-06480605
    Intervention: Drug: 450 mg
  • Experimental: 150 mg
    PF-06480605
    Intervention: Drug: 150 mg
  • Experimental: 50 mg
    PF-06480605
    Intervention: Drug: 50 mg
  • Placebo Comparator: 0 mg
    Intervention: Other: 0 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 22, 2023
Estimated Primary Completion Date September 22, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:-

  • A diagnosis of UC for ?3 months.
  • Participants with moderate to severe active UC as defined by a Total Mayo Score of

    ?6, and an endoscopic subscore of ?2.

  • Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
  • 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:

  • Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.).
  • Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study
  • Chest Radiograph showing abnormalities: 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.
  • 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
  • Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection.
  • Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   Colombia,   France,   Germany,   Hungary,   India,   Italy,   Japan,   Mexico,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT04090411
Other Study ID Numbers  ICMJE B7541007
TL1A ( Other Identifier: Alias Study Number )
Tuscany 2 ( Other Identifier: Alias Study Number )
2019-002698-74 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description: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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP