Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

NCT01284062

Last updated date
Study Location
The Kirkland Clinic
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or Female, Age >=18 and <=65 years

- Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score

- women of childbearing potential with highly effective method of contraception

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


- Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV,
positive or history of tuberculosis infection, active enteric infections, transplant
organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Ulcerative ColitisTofacitinib in Adult Patients With Moderate to Severe Ulcerative Colitis NCT04424303
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Ulcerative ColitisA Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis NCT00928681
  1. Brussels,
  2. Bruxelles,
  3. Leuven,
  4. Brno,
  5. Praha 2,
  6. Praha 2,
  7. Aarhus C,
  8. Berlin,
  9. Kiel,
  10. Muenster,
  11. Regensburg,
  12. Oslo,
  13. Nitra,
  14. L'hospitalet Del Llobregat, Barcelona
  15. Majadahonda, Madrid
  16. Barcelona,
  17. Barcelona,
  18. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Ulcerative ColitisA Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis NCT01240915
  1. San Francisco, California
  2. San Francisco, California
  3. Lafayette, Colorado
  4. Lakewood, Colorado
  5. Littleton, Colorado
  6. Washington, District of Columbia
  7. Clearwater, Florida
  8. Clearwater, Florida
  9. Clearwater, Florida
  10. Jacksonville, Florida
  11. Jacksonville, Florida
  12. South Miami, Florida
  13. Chicago, Illinois
  14. Topeka, Kansas
  15. Louisville, Kentucky
  16. Louisville, Kentucky
  17. Chevy Chase, Maryland
  18. Towson, Maryland
  19. Chesterfield, Michigan
  20. Troy, Michigan
  21. Utica, Michigan
  22. Columbia, Missouri
  23. Mexico, Missouri
  24. New York, New York
  25. New York, New York
  26. New York, New York
  27. Charlotte, North Carolina
  28. Raleigh, North Carolina
  29. Raleigh, North Carolina
  30. Winston Salem, North Carolina
  31. Germantown, Tennessee
  32. Nashville, Tennessee
  33. Norfolk, Virginia
  34. Norfolk, Virginia
  35. Norfolk, Virginia
  36. Richmond, Virginia
  37. Seattle, Washington
  38. Brussels,
  39. Bruxelles,
  40. Edmonton, Alberta
  41. Edmonton, Alberta
  42. Edmonton, Alberta
  43. Montreal, Quebec
  44. Frankfurt am Main,
  45. Halle,
  46. Hannover,
  47. Budapest,
  48. Gyula,
  49. Mosonmagyarovar,
  50. Szekszard,
  51. Milano,
  52. Padova,
  53. Roma,
  54. Bratislava,
  55. Trnava,
  56. Goteborg,
  57. Stockholm,
  58. Uppsala,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Ulcerative ColitisA Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis NCT01465763
  1. Mobile, Alabama
  2. Mobile, Alabama
  3. La Jolla, California
  4. La Jolla, California
  5. La Jolla, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Palm Springs, California
  12. Palm Springs, California
  13. Palm Springs, California
  14. Rancho Mirage, California
  15. San Diego, California
  16. San Diego, California
  17. San Diego, California
  18. Guilford, Connecticut
  19. Hamden, Connecticut
  20. Hamden, Connecticut
  21. Hamden, Connecticut
  22. Altamonte Springs, Florida
  23. Maitland, Florida
  24. Maitland, Florida
  25. Maitland, Florida
  26. Orange Park, Florida
  27. Orange Park, Florida
  28. Orlando, Florida
  29. Orlando, Florida
  30. Winter Park, Florida
  31. Zephyrhills, Florida
  32. Alpharetta, Georgia
  33. Atlanta, Georgia
  34. Johns Creek, Georgia
  35. Macon, Georgia
  36. Marietta, Georgia
  37. Suwanee, Georgia
  38. Suwanee, Georgia
  39. Oak Lawn, Illinois
  40. Ann Arbor, Michigan
  41. Ann Arbor, Michigan
  42. Ann Arbor, Michigan
  43. Ann Arbor, Michigan
  44. Ann Arbor, Michigan
  45. Ypsilanti, Michigan
  46. Ypsilanti, Michigan
  47. Ypsilanti, Michigan
  48. Saint Louis, Missouri
  49. Saint Louis, Missouri
  50. Great Neck, New York
  51. Great Neck, New York
  52. New York, New York
  53. New York, New York
  54. New York, New York
  55. New York, New York
  56. New York, New York
  57. New York, New York
  58. New York, New York
  59. Cleveland, Ohio
  60. Mentor, Ohio
  61. Mentor, Ohio
  62. Mentor, Ohio
  63. Houston, Texas
  64. Houston, Texas
  65. Houston, Texas
  66. Houston, Texas
  67. Salt Lake City, Utah
  68. Salt Lake City, Utah
  69. Salt Lake City, Utah
  70. West Jordan, Utah
  71. Milwaukee, Wisconsin
  72. Camperdown, New South Wales
  73. Kingswood, New South Wales
  74. Box Hill, Victoria
  75. Wien,
  76. Leuven,
  77. Calgary, Alberta
  78. Hamilton, Ontario
  79. Hamilton, Ontario
  80. London, Ontario
  81. Montreal, Quebec
  82. Barranquilla, Atlantico
  83. Zadar,
  84. Hradec Kralove,
  85. Praha 4,
  86. Praha 7,
  87. Aalborg,
  88. Aarhus C,
  89. Tallinn,
  90. Tallinn,
  91. Tallinn,
  92. Nantes,
  93. Paris,
  94. Toulouse Cedex 9,
  95. Berlin,
  96. Halle,
  97. Hannover,
  98. Lüneburg,
  99. Budapest,
  100. Pecs,
  101. Szeged,
  102. Vac,
  103. Petah Tikva,
  104. Tel Aviv,
  105. Catanzaro, CZ
  106. Rozzano, Milano
  107. Palermo, PA
  108. Palermo, PA
  109. Aviano,
  110. Milan,
  111. Nagakute, Aichi
  112. Hirosaki, Aomori
  113. Chiba-shi, Chiba
  114. Sakura, Chiba
  115. Kurume, Fukuoka
  116. Sapporo, Hokkaido
  117. Nishinomiya, Hyogo
  118. Higashi-ibaraki-gun, Ibaraki
  119. Kochi-shi, Kochi
  120. Sendai, Miyagi
  121. Takatsuki-shi, Osaka
  122. Otsu-shi, Shiga
  123. Hachioji, Tokyo
  124. Minato-ku, Tokyo
  125. Minato-ku, Tokyo
  126. Shinagawa-ku, Tokyo
  127. Shinagawa-ku, Tokyo
  128. Fukuoka,
  129. Hiroshima,
  130. Kagoshima,
  131. Osaka,
  132. Tokyo,
  133. Tokyo,
  134. Riga,
  135. Riga,
  136. Riga,
  137. Leiden, ZH
  138. Milford, Auckland
  139. Dunedin,
  140. Tauranga,
  141. Bydgoszcz, Kujawsko-pomorskie
  142. Warszawa, Mazowieckie
  143. Lodz,
  144. Wroclaw,
  145. Timisoara, Jud Timis
  146. Pyatigorsk, Stavropol Region
  147. Nizhniy Novgorod,
  148. Novosibirsk,
  149. Novosibirsk,
  150. Novosibirsk,
  151. Saint-Petersburg,
  152. Saint-Petersburg,
  153. Samara,
  154. Samara,
  155. Samara,
  156. St. Petersburg,
  157. Zrenjanin, Serbia, Europe
  158. Belgrade,
  159. Belgrade,
  160. Kragujevac,
  161. Bratislava,
  162. Johannesburg, Gauteng
  163. Cape Town, Western Cape
  164. Barcelona,
  165. Madrid,
  166. Madrid,
  167. Madrid,
  168. Simferopol, Ar Krym
  169. Kharkov,
  170. Kyiv,
  171. Lviv,
  172. Lviv,
  173. Odesa,
  174. Uzhgorod,
  175. Vinnytsia,
  176. Vinnytsia,
  177. Cambridge,
  178. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
Official Title  ICMJE A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis
Brief Summary This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • Biological: Anrukinzumab
    200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
    Other Name: PF-05230917
  • Biological: Anrukinzumab
    200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
    Other Name: PF-05230917
  • Biological: Anrukinzumab
    200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed.
    Other Name: PF-05230917
  • Other: placebo
    200 mg liquid sterile vial, administered at matching dose level 200 mg, 400 mg or 600 mg intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
Study Arms  ICMJE
  • Experimental: Arm 1
    200 mg PF-05230917, Anrukinzumab active dose level
    Intervention: Biological: Anrukinzumab
  • Experimental: Arm 2
    400 mg PF-05230917, Anrukinzumab active dose level
    Intervention: Biological: Anrukinzumab
  • Experimental: Arm 3
    600 mg PF-05230917, Anrukinzumab active dose level
    Intervention: Biological: Anrukinzumab
  • Placebo Comparator: Arm 4
    Matching placebo - administered at matching dose level 200 mg, 400 mg or 600 mg.
    Intervention: Other: placebo
Publications * Reinisch W, Panés J, Khurana S, Toth G, Hua F, Comer GM, Hinz M, Page K, O'Toole M, Moorehead TM, Zhu H, Sun Y, Cataldi F. Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study. Gut. 2015 Jun;64(6):894-900. doi: 10.1136/gutjnl-2014-308337. Epub 2015 Jan 7.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2013)
84
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2011)
80
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female, Age >=18 and <=65 years
  • Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score
  • women of childbearing potential with highly effective method of contraception

Exclusion Criteria:

  • Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV, positive or history of tuberculosis infection, active enteric infections, transplant organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Bulgaria,   Canada,   France,   Germany,   Hungary,   Netherlands,   Poland,   Romania,   Spain,   United States
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT01284062
Other Study ID Numbers  ICMJE B2421003
IMA-638 Anti-IL13 mAb
2010-023762-49 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 November 2014

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