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
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion
Merida, Yucatan, 97130, Mexico
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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
  1. Merida, Yucatan
  2. Dothan, Alabama
  3. Dothan, Alabama
  4. Dothan, Alabama
  5. Little Rock, Arkansas
  6. Canoga Park, California
  7. Newport Beach, California
  8. Colorado Springs, Colorado
  9. Colorado Springs, Colorado
  10. Colorado Springs, Colorado
  11. Guilford, Connecticut
  12. Hamden, Connecticut
  13. Hamden, Connecticut
  14. Hamden, Connecticut
  15. Hamden, Connecticut
  16. Brooksville, Florida
  17. Clearwater, Florida
  18. Clearwater, Florida
  19. Oldsmar, Florida
  20. Tampa, Florida
  21. Tampa, Florida
  22. Tampa, Florida
  23. Decatur, Georgia
  24. Decatur, Georgia
  25. Roswell, Georgia
  26. Chicago, Illinois
  27. Chicago, Illinois
  28. Iowa City, Iowa
  29. Lexington, Kentucky
  30. Lexington, Kentucky
  31. Boston, Massachusetts
  32. Boston, Massachusetts
  33. Chestnut Hill, Massachusetts
  34. Farmington Hills, Michigan
  35. Las Vegas, Nevada
  36. Las Vegas, Nevada
  37. Dayton, Ohio
  38. Dayton, Ohio
  39. Dayton, Ohio
  40. Dayton, Ohio
  41. Huber Heights, Ohio
  42. Springboro, Ohio
  43. Greenville, South Carolina
  44. Greenville, South Carolina
  45. Nashville, Tennessee
  46. Nashville, Tennessee
  47. Nashville, Tennessee
  48. Nashville, Tennessee
  49. Nashville, Tennessee
  50. Nashville, Tennessee
  51. Nashville, Tennessee
  52. Houston, Texas
  53. Houston, Texas
  54. Houston, Texas
  55. McAllen, Texas
  56. San Antonio, Texas
  57. Fairfax, Virginia
  58. Fairfax, Virginia
  59. Wauwatosa, Wisconsin
  60. Wauwatosa, Wisconsin
  61. Wauwatosa, Wisconsin
  62. Concord, New South Wales
  63. South Brisbane, Queensland
  64. Adelaide, South Australia
  65. Murdoch, Western Australia
  66. Leuven,
  67. Ruse,
  68. Sofia,
  69. Sofia,
  70. Sofia,
  71. Amiens Cedex 1,
  72. Lille Cedex,
  73. Lille Cedex,
  74. Lille Cedex,
  75. Nantes Cedex 1,
  76. Pierre-Benite Cedex,
  77. Pierre-Bénite Cedex,
  78. Berlin,
  79. Halle/Saale,
  80. Balatonfured, Veszprem
  81. Budapest,
  82. Tatabanya,
  83. Vac,
  84. Rajkot, Gujarat
  85. Surat, Gujarat
  86. Surat, Gujarat
  87. Bangalore, Karnataka
  88. Pune, Maharashtra
  89. Pune, Maharashtra
  90. Jaipur, Rajasthan
  91. Jaipur, Rajasthan
  92. Castellana Grotte, Bari
  93. Rozzano, Milan
  94. Roma, RM
  95. Negar Di Valpolicella, Verona
  96. Padova,
  97. Nagakute, Aichi
  98. Hirosaki, Aomori
  99. Sakura, Chiba
  100. Kurume, Fukuoka
  101. Asahikawa, Hokkaido
  102. Sapporo, Hokkaido
  103. Morioka, Iwate
  104. Sendai, Miyagi
  105. Takatsuki-shi, Osaka
  106. Bunkyo-ku, Tokyo
  107. Meguro-Ku, Tokyo
  108. Minato-ku, Tokyo
  109. Shinjuku-ku, Tokyo
  110. Fukuoka,
  111. Guadalajara, Jalisco
  112. Ciudad de Mexico,
  113. Queretaro,
  114. Wroclaw, Dolnoslaskie
  115. Bialystok,
  116. Knurow,
  117. Sopot,
  118. Szczecin,
  119. Warszawa,
  120. Warszawa,
  121. Wroclaw,
  122. Pyatigorsk, Stavropol Region
  123. Moscow,
  124. Omsk,
  125. Perm,
  126. Samara,
  127. Saratov,
  128. Smolensk,
  129. Tomsk,
  130. Tyumen,
  131. Tyumen,
  132. Yaroslavl,
  133. Bratislava,
  134. Presov,
  135. Vranov nad Toplou,
  136. Bloemfontein, FREE State
  137. Bloemfontein, FREE State
  138. Bloemfontein, FREE State
  139. Johannesburg, Gauteng
  140. Johannesburg, Gauteng
  141. Kempton Park, Gauteng
  142. Kempton Park, Gauteng
  143. Parktown, Gauteng
  144. Pretoria, Gauteng
  145. Pretoria, Gauteng
  146. Pretoria, Gauteng
  147. Johannesburg,
  148. Fuenlabrada, Madrid
  149. Madrid,
  150. Patumwan, Bangkok
  151. Hat Yai, Songkhla
  152. Bangkoknoi,
  153. Bangkok,
  154. Bangkok,
  155. Chiang Mai,
  156. Khon Kaen,
  157. Ankara,
  158. Istanbul,
  159. Istanbul,
  160. Kocaeli,
  161. Mersin,
  162. Zonguldak,
  163. Kharkiv,
  164. Kharkiv,
  165. Kyiv,
  166. Kyiv,
  167. Kyiv,
  168. Vinnytsia,
  169. Zaporizhzhia,
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,   Belgium,   Bulgaria,   France,   Germany,   Hungary,   India,   Italy,   Japan,   Mexico,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Thailand,   Turkey,   Ukraine,   United States
Removed Location Countries Canada,   United Kingdom
 
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 January 2021

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