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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 : November 7, 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  (Clinical Trial)
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 [ Time Frame: Baseline through Week 56 ]
  10. Number of clinically significant abnormalities in electrocardiograms [ 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 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.

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

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Locations
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United States, California
Wallace Rheumatic Studies Center, LLC Recruiting
Beverly Hills, California, United States, 90211
Advanced Medical Research, LLC Recruiting
La Palma, California, United States, 90623
Arthritis and Osteoporosis Medical Center Recruiting
La Palma, California, United States, 90623
Desert Medical Advances Recruiting
Palm Desert, California, United States, 92260-9368
Inland Rheumatology and Osteoporosis Medical Group Recruiting
Upland, California, United States, 91786
Inland Rheumatology Clinical Trials, Inc. Recruiting
Upland, California, United States, 91786
United States, Colorado
Denver Arthritis Clinic Not yet recruiting
Denver, Colorado, United States, 80230
United States, Connecticut
New England Research Associates Recruiting
Bridgeport, Connecticut, United States, 06606
Stamford Therapeutics Consortium Recruiting
Stamford, Connecticut, United States, 06905
United States, Florida
Clinical Research of West Florida Recruiting
Clearwater, Florida, United States, 33765
Private Practice of Robert W. Levin Recruiting
Clearwater, Florida, United States, 33765
SIMEDHealth, LLC Attn: Rheumatology Recruiting
Gainesville, Florida, United States, 32607
SIMEDHealth, LLC Recruiting
Gainesville, Florida, United States, 32607
Lakes Research LLC Not yet recruiting
Miami Lakes, Florida, United States, 33014
Omega Research MetroWest, LLC Recruiting
Orlando, Florida, United States, 32835
Akumin, Inc Recruiting
Palm Harbor, Florida, United States, 34685
Akumin Inc Recruiting
Saint Petersburg, Florida, United States, 33703
West Broward Rheumatology Associates, Inc Recruiting
Tamarac, Florida, United States, 33321
Akumin Inc. Recruiting
Tampa, Florida, United States, 33603
Clinical Research of West Florida Recruiting
Tampa, Florida, United States, 33603
AdventHealth Medical Group Not yet recruiting
Tampa, Florida, United States, 33614
United States, Idaho
Institute of Arthritis Research Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Nevada
Innovative health Research Recruiting
Las Vegas, Nevada, United States, 89128
United States, New York
NYU Langone Ambulatory Care Brooklyn Heights Not yet recruiting
Brooklyn, New York, United States, 11201
St. Lawrence Health System Recruiting
Canton, New York, United States, 13617
NYU Langone Health Perlmutter Cancer Center Lake Success Not yet recruiting
Lake Success, New York, United States, 11042
NYU Langone Rheumatology Associates Long Island. Not yet recruiting
Lake Success, New York, United States, 11042
Feinstein Institute for Medical Research Not yet recruiting
Manhasset, New York, United States, 11030
St. Lawrence Health System Recruiting
Potsdam, New York, United States, 13676
United States, North Carolina
Joint and Muscle Research Institute Recruiting
Charlotte, North Carolina, United States, 28204
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma PLLC Recruiting
Oklahoma City, Oklahoma, United States, 73102
United States, Pennsylvania
East Penn Rheumatology Associates, PC Not yet recruiting
Bethlehem, Pennsylvania, United States, 18015
United States, Tennessee
West Tennessee Research Institute Recruiting
Jackson, Tennessee, United States, 38305
Gupta, Ramesh C MD Recruiting
Memphis, Tennessee, United States, 38119-5214
United States, Texas
Tekton Research Recruiting
Austin, Texas, United States, 78745
Accurate Clinical Management, LLC Recruiting
Baytown, Texas, United States, 77521
Rheumatic Disease Clinical Research Center, LLC Recruiting
Houston, Texas, United States, 77004
ACR Recruiting
Houston, Texas, United States, 77034
Arthritis Clinic of Central Texas Recruiting
San Marcos, Texas, United States, 78666
United States, Washington
Arthritis Northwest, PLLC Not yet recruiting
Spokane, Washington, United States, 99204
Bulgaria
MHAT Plovdiv AD Not yet recruiting
Plovdiv, Bulgaria, 4000
Umhat Kanev Ad Not yet recruiting
Ruse, Bulgaria, 7002
Canada, Quebec
Centre de Recherche Musculo-Squelettique Not yet recruiting
Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Hungary
Qualiclinic Kft. Not yet recruiting
Budapest, Hungary, 1036
Japan
National Hospital Organization Asahikawa Medical Center Not yet recruiting
Asahikawa, Hokkaido, Japan, 070-8644
Sasebo Chuo Hospital Not yet recruiting
Sasebo, Nagasaki, Japan, 857-1195
National Hospital Organization Chiba-East Hospital Not yet recruiting
Chiba, Japan, 260-8712
National Hospital Organization Kyushu Medical Center Not yet recruiting
Fukuoka, Japan, 810-8563
Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital Not yet recruiting
Seocho-gu, Seoul, Korea, Republic of, 06591
Kyungpook National University Hospital (KNUH) Not yet recruiting
Daegu, Korea, Republic of, 41944
Kyungpook National University Hospital (KNUH) Not yet recruiting
Daegu, Korea, Republic of, 700-721
Inha University Hospital IRB Not yet recruiting
Incheon, Korea, Republic of, 22332
Konkuk University medical center Not yet recruiting
Seoul, Korea, Republic of, 05030
Poland
Stanislaw Sierakowski Centrum Miriada Prywatny Gabinet Specjalistyczny prof. dr. Stanislawa Sierakow Not yet recruiting
Bialystok, Poland, 15-297
Mazowieckie Centrum Reumatologii i Osteoporozy M. Przygodzka Spolka jawna Not yet recruiting
Warszawa, Poland, 04-030
Romania
Centrul Medical de Diagnostic si Tratament Ambulator Neomed Not yet recruiting
Brasov, JUD. Brasov, Romania, 500283
Spitalul Clinic Judetean de Urgenta Cluj-Napoca Not yet recruiting
Cluj-Napoca, Jud. Cluj, Romania, 400006
Spitalul Clinic Sf. Maria Not yet recruiting
Bucharest, Sector 1, Romania, 011172
S.C. Euroclinic Hospital S.A Not yet recruiting
Bucuresti, Sector 1, Romania, 014461
Taiwan
China Medical University Hospital Not yet recruiting
Taichung City, Taiwan (r.o.c), Taiwan, 40447
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: November 7, 2019
Last Verified: November 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