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

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ClinicalTrials.gov Identifier: NCT03845517
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Placebo Drug: PF-06700841 15 mg Drug: PF-06700841 30 mg Drug: PF-06700841 45 mg Phase 2

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Study Type : Interventional
Estimated Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : September 7, 2022
Estimated Study Completion Date : September 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

Experimental: PF-06700841 15 mg
PF-06700841 15 mg
Drug: PF-06700841 15 mg
PF-06700841 15 mg

Experimental: PF-06700841 30 mg
PF-06700841 30 mg
Drug: PF-06700841 30 mg
PF-06700841 30 mg

Experimental: PF-06700841 45 mg
PF-06700841 45 mg
Drug: PF-06700841 45 mg
PF-06700841 45 mg




Primary Outcome Measures :
  1. Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52. [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Time to first severe flare in PF 06700841 treated participants relative to placebo. [ Time Frame: Baseline, Week 52 ]
  2. Proportion of participants achieving the Lupus Low Disease Activity State (LLDAS) at Week 52. [ Time Frame: Baseline, Week 52 ]
  3. Proportion of participants achieving a reduction in prednisone (or equivalent) at Week 52. [ Time Frame: Baseline, Week 52 ]
  4. Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI-A Total Activity Score [ Time Frame: Baseline, Week 52 ]
  5. Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52. [ Time Frame: Baseline, Week 52 ]
  6. Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52. [ Time Frame: Baseline, Week 52 ]
  7. Number of treatment emergent adverse events (AE's) [ Time Frame: Baseline through Week 56 ]
  8. Number of discontinuations due to AE's [ Time Frame: Baseline through Week 56 ]
  9. Number of clinically significant abnormalities in vital signs and ECGs. [ Time Frame: Baseline through Week 56 ]
  10. Number of clinically significant abnormalities in Echocardiograms [ Time Frame: Baseline through Week 56 ]
  11. Number of clinically significant abnormalities in clinical laboratory values. [ Time Frame: Baseline through Week 56 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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/or have documented failed therapy with methotrexate, azathioprine, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845517


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Desert Medical Advances Not yet recruiting
Palm Desert, California, United States, 92260-9368
United States, Connecticut
Stamford Therapeutics Consortium Not yet recruiting
Stamford, Connecticut, United States, 06905
United States, Florida
Southeastern Integrated Medical Not yet recruiting
Gainesville, Florida, United States, 32607
Akumin Inc. Not yet recruiting
Tampa, Florida, United States, 33603
Clinical Research of West Florida Not yet recruiting
Tampa, Florida, United States, 33603
United States, Tennessee
Gupta, Ramesh C MD Not yet recruiting
Memphis, Tennessee, United States, 38119-5214
United States, Texas
Tekton Research Recruiting
Austin, Texas, United States, 78745
Accurate Clinical Management, LLC Not yet recruiting
Baytown, Texas, United States, 77521
ACR Not yet recruiting
Houston, Texas, United States, 77034
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03845517     History of Changes
Other Study ID Numbers: B7931028
2018-004175-12 ( EudraCT Number )
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases