A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Back to Search
Print
Bookmark Trial

NCT03845517

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Medizinische Hochschule Hannover
Hannover, , 30625, Germany
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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.
Systemic Lupus Erythematosus
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

- Male and/or female subjects between ≥18 and ≤75 years of age inclusive.

- Diagnosis of moderate to severe active Lupus.

- Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.

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


- Active renal lupus


- Severe active central nervous system (CNS) lupus


- Have cancer or a history of cancer within 5 years of screening.


- Have a history of thrombosis (venous or arterial) or other vascular complications
within the last 6 months, or any history of either recurrent thrombosis or a pulmonary
embolus.


- Active bacterial, viral, fungal, mycobacterial or other infections


- Psychiatric condition including recent or active suicidal ideation or behavior


- Have active fibromyalgia/myofascial/chronic pain.


- Pregnant female subjects; breastfeeding female subjects; females subjects planning to
become pregnant during the study; fertile male subjects and WOCBP who are unwilling or
unable to use a highly effective method of contraception.

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]

Call Now

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.

Advanced Search

Based on your search, you may also be interested in

Systemic Lupus ErythematosusSubcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
NCT01405196
  1. Anniston, Alabama
  2. Anniston, Alabama
  3. Birmingham, Alabama
  4. Fair Oaks, California
  5. Lakewood, California
  6. Long Beach, California
  7. Long Beach, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Los Angeles, California
  13. Los Angeles, California
  14. Upland, California
  15. Upland, California
  16. Daytona Beach, Florida
  17. Gainesville, Florida
  18. Gainesville, Florida
  19. Gainesville, Florida
  20. Gainesville, Florida
  21. Miami, Florida
  22. Orlando, Florida
  23. Ormond Beach, Florida
  24. Palm Harbor, Florida
  25. Pinellas Park, Florida
  26. Tampa, Florida
  27. Atlanta, Georgia
  28. Atlanta, Georgia
  29. Meridian, Idaho
  30. Chicago, Illinois
  31. Granger, Indiana
  32. Indianapolis, Indiana
  33. Indianapolis, Indiana
  34. Baltimore, Maryland
  35. Baltimore, Maryland
  36. Baltimore, Maryland
  37. Boston, Massachusetts
  38. Ann Arbor, Michigan
  39. Ann Arbor, Michigan
  40. Ann Arbor, Michigan
  41. Detroit, Michigan
  42. Saint Clair Shores, Michigan
  43. Las Vegas, Nevada
  44. Albuquerque, New Mexico
  45. Brooklyn, New York
  46. Manhasset, New York
  47. New York, New York
  48. Rochester, New York
  49. Chapel Hill, North Carolina
  50. Chapel Hill, North Carolina
  51. Chapel Hill, North Carolina
  52. Charlotte, North Carolina
  53. Charlotte, North Carolina
  54. Cleveland, Ohio
  55. Middleburg Heights, Ohio
  56. Oklahoma City, Oklahoma
  57. Wyomissing, Pennsylvania
  58. Charleston, South Carolina
  59. Jackson, Tennessee
  60. Jackson, Tennessee
  61. Dallas, Texas
  62. Dallas, Texas
  63. Houston, Texas
  64. Houston, Texas
  65. Mesquite, Texas
  66. Seattle, Washington
  67. Tacoma, Washington
  68. Clarksburg, West Virginia
  69. La Plata, Buenos Aires
  70. Rosario, Santa FE
  71. San Miguel de Tucuman, Tucuman
  72. C.a.b.a,
  73. San Juan,
  74. Santiago, Region Metropolitana
  75. Santiago, RM
  76. Santiago, RM
  77. Envigado, Antioquia, Colombia
  78. Envigado, Antioquia
  79. Medellin, Antioquia
  80. Barranquilla, Atlantico
  81. Barranquilla, Atlantico
  82. Barranquilla, Atlantico
  83. Bogota, Distrito Capital, Cundimarca
  84. Bogota, Cundinamarca
  85. Bogota, Cundinamarca
  86. Bucaramanga, Santander
  87. Bogota,
  88. Berlin,
  89. Berlin,
  90. Erlangen,
  91. Frankfurt/Main,
  92. Koeln,
  93. Leipzig,
  94. Budapest,
  95. Debrecen,
  96. Gyula,
  97. Busan,
  98. Chisinau, Md-2025
  99. San Isidro, Lima
  100. Santiago de Surco, Lima
  101. Surco, Lima
  102. Arequipa,
  103. Elblag,
  104. Poznan,
  105. Poznan,
  106. Warszawa,
  107. Rio Piedras,
  108. San Juan,
  109. Bucuresti,
  110. Bucuresti,
  111. Cluj Napoca,
  112. Galati,
  113. Taipei TOC,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Systemic Lupus ErythematosusStudy Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus
NCT00714116
  1. South Miami, Florida
  2. South Miami, Florida
  3. South Miami, Florida
  4. Durham, North Carolina
  5. Duncansville, Pennsylvania
  6. Dallas, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Systemic Lupus ErythematosusStudy of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus
NCT00479622
  1. Los Angeles, California
  2. Palo Alto, California
  3. Lake Success, New York
  4. Rochester, New York
  5. Charlotte, North Carolina
  6. Columbus, Ohio
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Systemic Lupus ErythematosusA DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
NCT03845517
  1. Hannover,
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Birmingham, Alabama
  5. Birmingham, Alabama
  6. Beverly Hills, California
  7. Fullerton, California
  8. La Palma, California
  9. La Palma, California
  10. Palm Desert, California
  11. Upland, California
  12. Upland, California
  13. Denver, Colorado
  14. Bridgeport, Connecticut
  15. Stamford, Connecticut
  16. Clearwater, Florida
  17. Clearwater, Florida
  18. Gainesville, Florida
  19. Gainesville, Florida
  20. Miami Lakes, Florida
  21. Orlando, Florida
  22. Palm Harbor, Florida
  23. Saint Petersburg, Florida
  24. Tamarac, Florida
  25. Tampa, Florida
  26. Tampa, Florida
  27. Tampa, Florida
  28. Decatur, Georgia
  29. Marietta, Georgia
  30. Idaho Falls, Idaho
  31. Kansas City, Kansas
  32. Kansas City, Kansas
  33. Kansas City, Kansas
  34. Baton Rouge, Louisiana
  35. Brighton, Michigan
  36. Las Vegas, Nevada
  37. Brooklyn, New York
  38. Canton, New York
  39. Manhasset, New York
  40. New York, New York
  41. New York, New York
  42. Potsdam, New York
  43. Syracuse, New York
  44. Syracuse, New York
  45. Syracuse, New York
  46. Charlotte, North Carolina
  47. Oklahoma City, Oklahoma
  48. Bethlehem, Pennsylvania
  49. Jackson, Tennessee
  50. Memphis, Tennessee
  51. Austin, Texas
  52. Baytown, Texas
  53. Houston, Texas
  54. Spokane, Washington
  55. Kogarah, New South Wales
  56. Camberwell, Victoria
  57. Leuven,
  58. Plovdiv,
  59. Ruse,
  60. Sofia,
  61. Sofia,
  62. Rimouski, Quebec
  63. Trois-Rivieres, Quebec
  64. Medellin, Antioquia
  65. Barranquilla, Atlantico
  66. Bogotá, Cundinamarca
  67. Bucaramanga, Santander
  68. Praha 2,
  69. Paris,
  70. Paris,
  71. Paris,
  72. Pessac,
  73. Strasbourg,
  74. Berlin,
  75. Lübeck,
  76. Mainz,
  77. Heraklion, Crete
  78. Athens,
  79. Haidari,
  80. Budapest,
  81. Debrecen,
  82. Gyula,
  83. Kitakyushu-shi, Fukuoka
  84. Asahikawa, Hokkaido
  85. Sapporo, Hokkaido
  86. Sendai, Miyagi
  87. Sasebo, Nagasaki
  88. Chuo-ku, Tokyo
  89. Shinjuku-ku, Tokyo
  90. Chiba,
  91. Fukuoka,
  92. Hiroshima,
  93. Seocho-gu, Seoul
  94. Suwon-si, Yeongtong-go
  95. Daegu,
  96. Incheon,
  97. Seoul,
  98. Mexico City, Cuauhtémoc
  99. León, Guanajuato
  100. Zapopan, Jalisco
  101. Mérida, Yucatán
  102. Chihuahua,
  103. Mexico City,
  104. Bialystok,
  105. Bydgoszcz,
  106. Lublin,
  107. Sosnowiec,
  108. Warszawa,
  109. Almada,
  110. Amadora,
  111. Coimbra,
  112. Ponte de Lima,
  113. Porto,
  114. Brasov, JUD. Brasov
  115. Cluj-Napoca, Jud. Cluj
  116. Iasi, Jud. Iasi
  117. Bucharest, Sector 1
  118. Bucuresti, Sector 1
  119. Bucuresti,
  120. Badalona,
  121. Barcelona,
  122. Barcelona,
  123. La Coruna,
  124. Sevilla,
  125. Taichung City, Taiwan (r.o.c)
  126. Kaohsiung City,
  127. Taichung,
  128. Taipei,
  129. Taipei,
  130. Kyiv,
  131. Lviv,
  132. Odesa,
  133. Odesa,
  134. Ternopil,
  135. Uzhgorod,
  136. Vinnytsia,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Official Title  ICMJE A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Brief Summary Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
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 Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Drug: PF-06700841 15 mg
    PF-06700841 15 mg
  • Drug: PF-06700841 30 mg
    PF-06700841 30 mg
  • Drug: PF-06700841 45 mg
    PF-06700841 45 mg
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06700841 15 mg
    PF-06700841 15 mg
    Intervention: Drug: PF-06700841 15 mg
  • Experimental: PF-06700841 30 mg
    PF-06700841 30 mg
    Intervention: Drug: PF-06700841 30 mg
  • Experimental: PF-06700841 45 mg
    PF-06700841 45 mg
    Intervention: Drug: PF-06700841 45 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: February 15, 2019)		448
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 7, 2022
Estimated Primary Completion Date September 7, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and/or female subjects between ?18 and ?75 years of age inclusive.
  • Diagnosis of moderate to severe active Lupus.
  • Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.

Exclusion Criteria:

  • Active renal lupus
  • Severe active central nervous system (CNS) lupus
  • Have cancer or a history of cancer within 5 years of screening.
  • Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus.
  • Active bacterial, viral, fungal, mycobacterial or other infections
  • Psychiatric condition including recent or active suicidal ideation or behavior
  • Have active fibromyalgia/myofascial/chronic pain.
  • Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.
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,   Canada,   Colombia,   Czechia,   France,   Germany,   Greece,   Hungary,   Japan,   Korea, Republic of,   Mexico,   Poland,   Portugal,   Romania,   Spain,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03845517
Other Study ID Numbers  ICMJE B7931028
2018-004175-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 June 2020

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