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

NCT03845517

Last updated date
Study Location
Millennium Clinical Trials
Thousand Oaks, California, 91360, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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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.

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Pfizer Clinical Trials Contact Center

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[email protected]

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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,   China,   Colombia,   Czechia,   France,   Germany,   Greece,   Hungary,   Japan,   Korea, Republic of,   Mexico,   Poland,   Portugal,   Romania,   Serbia,   Spain,   Taiwan,   Ukraine,   United Kingdom,   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 September 2020

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