A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.
NCT ID: NCT02185040
Last Updated: 2020-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2014-09-16
2018-09-25
Brief Summary
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Detailed Description
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Subject participation in Part 1 consists of 3 phases:
* Pre-treatment Screening Phase: up to 28 days prior to the first dose of the investigational product (IP)
* Treatment Phase: up to 84 days
* Observation Phase: 84 day post-treatment A total of approximately 40 subjects will be randomized into 4 dose groups with a 4:1 ratio of CC-220 (0.3 mg every other day \[QOD\], 0.3 mg everyday \[QD\], 0.6 mg and 0.3 mg on alternating days, and 0.6 mg QD) or matching placebo. In each dosing arm, 8 subjects will receive active drug and 2 subjects will receive placebo. The Treatment Phase will be up to 84 days in duration for all dose groups. Subjects who discontinue IP early and all subjects who complete the 84 day treatment phase will enter into the Observational Follow-up Phase for an 84 day period. A subject will be permitted to reduce their dose one time during Part 1 of the study.
Part 2 is the Active Treatment Extension Phase (ATEP) which is an extension to evaluate the long-term efficacy and safety/tolerability of CC-220 in SLE subjects who completed Part 1 of the study. Subjects who complete the Treatment Phase of Part 1 of the study will be eligible to receive CC-220 in the ATEP for up to 2 years. All subjects who participate in the ATEP will receive either 0.3 mg QD or 0.6 mg and 0.3 mg QD on alternating days. Subjects who terminate the Treatment Phase of Part 1 early will not be eligible for entry into the ATEP.
Subject participation consists of two phases:
* Active Treatment Extension Phase: Up to 2 years
* Observational Follow-up Phase: One month
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CC-220 0.3mg Every Other Day (QOD)
Part 1: CC-220 0.3mg capsules by mouth every other day (QOD)
CC-220
0.3 mg oral capsules once every other day with or without food
CC-220 0.3mg Every Day (QD)
* Part 1: CC-220 0.3mg capsules by mouth every day (QD)
* ATEP: CC-220 0.3 mg capsules by mouth every day (QD)
CC-220
Subjects will receive 0.3 mg oral capsules every day with or without food
CC-220 0.6mg/0.3mg alternating dose QD
* Part 1: CC-220 0.6 mg and 0.3mg capsules PO on alternating days
* ATEP:CC-220 0.6 mg and 0.3 mg capsules PO on alternating days
CC-220
CC-220 oral capsules 0.6 mg and 0.3 mg on alternating days with or without food
CC-220 0.6mg QD
Part 1: CC-220 0.6mg capsules by mouth QD
CC-220
CC-220 oral capsule 0.6 mg QD with or without food
Placebo QD
Part 1: Identically matching placebo capsules PO QD
Placebo
Matching oral placebo daily
Interventions
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CC-220
0.3 mg oral capsules once every other day with or without food
CC-220
Subjects will receive 0.3 mg oral capsules every day with or without food
CC-220
CC-220 oral capsules 0.6 mg and 0.3 mg on alternating days with or without food
CC-220
CC-220 oral capsule 0.6 mg QD with or without food
Placebo
Matching oral placebo daily
Eligibility Criteria
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Inclusion Criteria
* The subject has an established diagnosis of systemic lupus erythematosus (SLE) as defined by the 1997 Update of the 1982 ACR Revised Criteria for Classification of SLE at screening. The diagnosis is fulfilled provided that at least 4 criteria are met.
* Disease history of SLE ≥ 6 months at baseline
* Females of childbearing potential (FCBP) must:
* Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact.
* Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
* Male subjects must:
* Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy.
* If the subject is using oral corticosteroids, the daily dose must be less than or equal to 10 mg of prednisone or equivalent during the study; the dose must be stable over the 4 weeks preceding screening and throughout the study.
* All subjects taking hydroxychloroquine, chloroquine and/or quinacrine during the study must have documentation of a normal ophthalmologic examination performed within 1 year of the Baseline Visit.
* For subjects not taking corticosteroids, or antimalarials, the last dose (in case of previous use) must be at least 4 weeks prior to screening.
ATEP
* Male or female 18 years of age or older
* Understand and voluntarily sign an ICD prior to the initiation of any study related assessments/procedures
* Able to adhere to the study visit schedule and other protocol requirements. Pregnancy
* Females of childbearing potential (FCBP) must:
* Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence\* from heterosexual contact.
* Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
* Male subjects must:
\- Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)
* Male subjects must agree not to donate semen or sperm during therapy and for at least 90 days following the discontinuation of IP.
* All subjects must:
* Understand that the IP could have potential teratogenic risk
* Agree to abstain from donating blood while taking IP and for 28 days following discontinuation of the IP
* Agree not to share IP with another person
* Other than the subject, FCBP and males able to father a child should not handle the IP or touch the capsules unless gloves are worn
* Be counseled about pregnancy precautions and risks of fetal exposure as described in the Pregnancy Prevention Plan. Concomitant Medications
* If the subject is using oral corticosteroids, the daily dose must be less than or equal to 10 mg of prednisone or equivalent during the study; the dose must be stable over the 4 weeks preceding randomization and throughout the study.
* All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study must have documentation of a normal ophthalmologic examination performed within 1 year of the Baseline Visit.
* For subjects not taking corticosteroids the last dose (in case of previous use) must be at least 4 weeks prior to screening.
Exclusion Criteria
* The subject has received high dose oral prednisone (\> 100 mg/day) within 4 weeks of screening.
* The subject has received cyclophosphamide, azathioprine or mycophenolate mofetil within 12 weeks of screening.
* The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 pharmacokinetic half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to screening; OR participation in two or more investigational drug trials within 12 months of screening.
* Unstable lupus nephritis defined as: proteinuria \> 1.0 g/24 hour /1.73 m2 OR eGFR of less than 60 mL/1.73 m2 CNS disease, including active severe CNS lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), cerebritis or CNS vasculitis) requiring therapeutic intervention within 6 months of screening.
* The subject has New York Heart Association (NYHA) Class III or IV congestive heart failure.
* Presence of hepatitis B surface antigen (HBsAG). Subjects may have a positive anti-hepatitis B core antibody (anti-HBc) if the anti-hepatitis B surface antibody (anti-HBs) is positive as well.
* Antibodies to hepatitis C at Screening.
* The subject has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease or acquired immune deficiency syndrome (AIDs).
* Has a history of an organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
* Malignancy or history of malignancy, except for:
* treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;
* treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of Screening
* Systemic bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 2 weeks prior to Screening and no new or recurrent infections prior to the Baseline visit.
* History of venous thrombosis or any thromboembolic events within 2 years of screening.
* Clinical evidence of significant unstable or uncontrolled acute or chronic disease not due to SLE (ie, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, psychiatric or infectious disease) which in the opinion of the investigator could put the subject at undue risk or confound study results.
* Presence of active uveitis or any other clinically significant ophthalmological finding.
* History or current diagnosis of peripheral or radicular neuropathy. Any clinically significant abnormalities on ECG, which, in the opinion of the investigator would interfere with safe participation in the study.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Shimon Korish, M.D.
Role: STUDY_DIRECTOR
Celgene
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Research, PLLC
Paradise Valley, Arizona, United States
University of Arizona Clinical and Translational Science Research Center
Tucson, Arizona, United States
UCSD Center for Innovative Therapy
La Jolla, California, United States
Dermatology Research Associates
Los Angeles, California, United States
East Bay Rheumatology Medical Group Inc.
San Leandro, California, United States
Clinical Science Institute
Santa Monica, California, United States
Los Angeles Biomedical Research Institute at Harbor - UCLA
Torrance, California, United States
Inland Rheumatology Clinical Trials
Upland, California, United States
Vipul Joshi, MD, PA, dba Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Advanced Medical Research
Atlanta, Georgia, United States
Arthritis Research and Treatment Center
Stockbridge, Georgia, United States
Northwestern Medical Group; Department of Dermatology
Chicago, Illinois, United States
Northshore University Health System
Skokie, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Northwell Health / Division of Rheumatology
Lake Success, New York, United States
Feinstein Institute For Medical Research
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
DJL Clinical Research
Charlotte, North Carolina, United States
MetroHealth Medical Systems
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States
UMPC Lupus Center of Excellence
Pittsburgh, Pennsylvania, United States
Low Country Rheumatology PA
Charleston, South Carolina, United States
Austin Regional Clinic
Austin, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Seattle Arthritis Clinic
Seattle, Washington, United States
Countries
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References
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Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: CC-220-SLE-001-SAP-Part1_Redacted25July2016
Document Type: Statistical Analysis Plan: CC-220-SLE-001-ATEP.31Oct2018_Redacted
Other Identifiers
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CC-220-SLE-001
Identifier Type: -
Identifier Source: org_study_id
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