Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2014-11-01
2017-06-30
Brief Summary
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Detailed Description
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Two dose cohorts of CC-220 (Cohort 1: 0.3 mg by mouth (PO) every day (QD) or matching placebo and Cohort 2: 0.6 mg PO QD or matching placebo) will be evaluated using a sequential, dose-ascending design
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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CC-220 0.3mg
CC-220 0.3 mg capsules by mouth (PO) daily for 12 weeks
CC-220 0.3 mg Daily
CC-220 0.6mg
CC-220 0.6mg capsules by PO daily for 12 weeks
CC-220 0.6mg Daily
Placebo
Identically matching placebo PO daily for 12 weeks
Placebo
Interventions
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CC-220 0.3 mg Daily
CC-220 0.6mg Daily
Placebo
Eligibility Criteria
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Inclusion Criteria
* Have chronic cutaneous sacrcoidosis (CCS) prior to consent
* Have active cutaneous sarcoidosis lesion(s) at screening
* Forced vital capacity of ≥ 45% of predicted normal value at screening.
* Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min.
* Females of childbearing potential must have negative pregnancy tests prior to starting study therapy and agree to either commit to true abstinence or use effective contraception.
* Male subjects must practice true abstinence or agree to use a condom even if he has undergone a successful vasectomy
Exclusion Criteria
* History of inadequately treated tuberculosis
* History of Human Immunodeficiency Virus (HIV) and/or Common Variable Immunodeficiency Disease.
* History of alcohol or drug abuse
* History or current peripheral neuropathy
* Current uveitis or any other clinically significant ophthalmological finding
* Currently require therapy for precapillary pulmonary hypertension.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Yufang Lu, MD, PhD
Role: STUDY_DIRECTOR
Celgene Corporation
Other Identifiers
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2014-001065-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-220-SAR-001
Identifier Type: -
Identifier Source: org_study_id
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