Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03845517
Recruitment Status : Active, not recruiting
First Posted : February 19, 2019
Last Update Posted : June 5, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional
Actual Enrollment : 350 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 : October 6, 2023
Estimated Study Completion Date : October 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. Proportion of participants achieving SRI-4 at Week 52 and have a sustained reduction of prednisone (or equivalent) at Week 52. [ Time Frame: Week 52 ]
  5. 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 ]
  6. 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 ]
  7. Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52. [ Time Frame: Baseline, Week 52 ]
  8. Number of treatment emergent adverse events (AE's) [ Time Frame: Baseline through Week 56 ]
  9. Number of discontinuations due to AE's [ Time Frame: Baseline through Week 56 ]
  10. Number of clinically significant abnormalities in vital signs [ Time Frame: Baseline through Week 56 ]
  11. Number of clinically significant abnormalities in electrocardiograms [ Time Frame: Baseline through Week 56 ]
  12. Number of clinically significant abnormalities in clinical laboratory values. [ Time Frame: Baseline through Week 56 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Show Show 157 study locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03845517    
Other Study ID Numbers: B7931028
2018-004175-12 ( EudraCT Number )
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: June 5, 2023
Last Verified: June 2023
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 PF-06700841
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action