search
Back to results

A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CC-220
CC-220
CC-220
CC-220
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus, Systemic Lupus, SLE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Part 1

  • 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 been treated with intra-articular, intramuscular or IV pulse corticosteroids within 4 weeks of screening.
  • 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.

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Arthritis and Rheumatology Research, PLLC
  • University of Arizona Clinical and Translational Science Research Center
  • UCSD Center for Innovative Therapy
  • Dermatology Research Associates
  • East Bay Rheumatology Medical Group Inc.
  • Clinical Science Institute
  • Los Angeles Biomedical Research Institute at Harbor - UCLA
  • Inland Rheumatology Clinical Trials
  • Vipul Joshi, MD, PA, dba Bay Area Arthritis and Osteoporosis
  • Emory University School of Medicine
  • Advanced Medical Research
  • Arthritis Research and Treatment Center
  • Northwestern Medical Group; Department of Dermatology
  • Northshore University Health System
  • Southern Illinois University School of Medicine
  • Tulane University Health Sciences Center
  • Northwell Health / Division of Rheumatology
  • Feinstein Institute For Medical Research
  • NYU Langone Medical Center
  • Columbia Presbyterian Medical Center
  • Univ of Rochester Medical Center
  • DJL Clinical Research
  • MetroHealth Medical Systems
  • Ohio State University Medical Center
  • University of Toledo Medical Center
  • Oklahoma Medical Research Foundation
  • Altoona Center for Clinical Research
  • University of Pennsylvania Health Systems
  • UMPC Lupus Center of Excellence
  • Low Country Rheumatology PA
  • Austin Regional Clinic
  • University of Texas Health Science Center at Houston
  • Virginia Clinical Research, Inc.
  • Seattle Arthritis Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

CC-220 0.3mg Every Other Day (QOD)

CC-220 0.3mg Every Day (QD)

CC-220 0.6mg/0.3mg alternating dose QD

CC-220 0.6mg QD

Placebo QD

Arm Description

Part 1: CC-220 0.3mg capsules by mouth every other day (QOD)

Part 1: CC-220 0.3mg capsules by mouth every day (QD) ATEP: CC-220 0.3 mg capsules by mouth every day (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

Part 1: CC-220 0.6mg capsules by mouth QD

Part 1: Identically matching placebo capsules PO QD

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase
A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase
A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.

Secondary Outcome Measures

Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide
The area under the plasma concentration time curve (AUCt) was defined as area under the concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Maximum Observed Concentration (Cmax) Of Iberdomide
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time to Reach Maximum Concentration (Tmax) of Iberdomide
Time to Cmax, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Terminal Phase Half-Life (T1/2) Of Iberdomide
Terminal phase half-life in plasma, calculated as [(In 2)/λz]. T1/2 half was only calculated when a reliable estimate for λz could be obtained. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point
The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point
The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Change From Baseline in Swollen Joint Count During the ATEP by Time Point
Joint swelling was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Change From Baseline in Tender Joint Count During the ATEP by Time Point
Joint tenderness was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point
The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point
The physician's global assessment was administered by the treating physician and was used to gauge the participants overall state of health. The instrument uses a visual analogue scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none 1 = mild disease 2 = moderate disease 3 = severe disease
Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point
The BILAG-2004 index measures clinical disease activity in systemic lupus erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 9 domains (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematologic). BILAG A represents the most active disease or severe disease; BILAG B represents intermediate activity or moderate disease; BILAG C represents stable mild disease; BILAG D represents organ system previously affected but now inactive; and BILAG E represents organ system never involved. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 9 domains. The theoretical range spans from 0 (no activity) to 13 active or severe disease activity BILAG. A higher score means more severe disease activity while a lower score means lower disease activity (or no disease activity for score of zero).
Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt
The pericardial/pleuritic pain scale was scored using numerical values of 1 through 10 with 1 representing 'no pain' and 10 representing 'worst possible pain'. These were self-administered by the participants and gauged the severity of their SLE pain related to pericardial and pleuritic discomfort. Any indication from participants or study assessments, aside from pain, which indicated clinically significant pericardial or pleuritic manifestations of SLE was thoroughly investigated; if clinically significant SLE related complications were found, the participants was to be discontinued from the study and entered into the Observational Follow-up Period and treated appropriately.
Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point
The Fatigue VAS evaluates SLE-related fatigue using a 0 to 100 mm VAS scale. The Fatigue VAS allowed the participant to indicate the degree of SLE-related fatigue by placing an "X" representing how they feel, along a visual analog line that extends between two extremes (e.g., from not at all tired to extremely tired) over the previous week. A decrease in the fatigue VAS indicates improvement.
Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point
The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point
SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.

Full Information

First Posted
July 7, 2014
Last Updated
March 5, 2020
Sponsor
Celgene
search

1. Study Identification

Unique Protocol Identification Number
NCT02185040
Brief Title
A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.
Official Title
A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 16, 2014 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
September 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether CC-220 is effective for the treatment of skin, joint and serological manifestations of systemic lupus erythematosus.
Detailed Description
The study consists of 2 parts. Part 1 is a randomized, double-blind, placebo controlled, ascending dose study to evaluate the safety and tolerability of CC-220 in SLE subjects. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus, Systemic Lupus, SLE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CC-220 0.3mg Every Other Day (QOD)
Arm Type
Experimental
Arm Description
Part 1: CC-220 0.3mg capsules by mouth every other day (QOD)
Arm Title
CC-220 0.3mg Every Day (QD)
Arm Type
Experimental
Arm Description
Part 1: CC-220 0.3mg capsules by mouth every day (QD) ATEP: CC-220 0.3 mg capsules by mouth every day (QD)
Arm Title
CC-220 0.6mg/0.3mg alternating dose QD
Arm Type
Experimental
Arm Description
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
Arm Title
CC-220 0.6mg QD
Arm Type
Experimental
Arm Description
Part 1: CC-220 0.6mg capsules by mouth QD
Arm Title
Placebo QD
Arm Type
Placebo Comparator
Arm Description
Part 1: Identically matching placebo capsules PO QD
Intervention Type
Drug
Intervention Name(s)
CC-220
Intervention Description
0.3 mg oral capsules once every other day with or without food
Intervention Type
Drug
Intervention Name(s)
CC-220
Intervention Description
Subjects will receive 0.3 mg oral capsules every day with or without food
Intervention Type
Drug
Intervention Name(s)
CC-220
Intervention Description
CC-220 oral capsules 0.6 mg and 0.3 mg on alternating days with or without food
Intervention Type
Drug
Intervention Name(s)
CC-220
Intervention Description
CC-220 oral capsule 0.6 mg QD with or without food
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching oral placebo daily
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase
Description
A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Time Frame
From the start of the first dose of IP until 28 days after the last dose or study discontinuation in Part 1; median treatment duration = 12.0 weeks for the placebo, 0.3 mg QOD and 0.3 mg iberdomide QD arms, 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts.
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase
Description
A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Time Frame
From the date of the first dose of IP in the ATEP until 28 days after the last dose in the ATEP or study discontinuation; median duration of IP was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts.
Secondary Outcome Measure Information:
Title
Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide
Description
The area under the plasma concentration time curve (AUCt) was defined as area under the concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame
Pharmacokinetic (PK) blood samples were collected on Day 1 and Day 29 pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Title
Maximum Observed Concentration (Cmax) Of Iberdomide
Description
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame
Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Title
Time to Reach Maximum Concentration (Tmax) of Iberdomide
Description
Time to Cmax, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame
Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Title
Terminal Phase Half-Life (T1/2) Of Iberdomide
Description
Terminal phase half-life in plasma, calculated as [(In 2)/λz]. T1/2 half was only calculated when a reliable estimate for λz could be obtained. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time Frame
Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Title
Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point
Description
The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Title
Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point
Description
The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Title
Change From Baseline in Swollen Joint Count During the ATEP by Time Point
Description
Joint swelling was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Title
Change From Baseline in Tender Joint Count During the ATEP by Time Point
Description
Joint tenderness was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Title
Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point
Description
The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Title
Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point
Description
The physician's global assessment was administered by the treating physician and was used to gauge the participants overall state of health. The instrument uses a visual analogue scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none 1 = mild disease 2 = moderate disease 3 = severe disease
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Title
Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point
Description
The BILAG-2004 index measures clinical disease activity in systemic lupus erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 9 domains (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematologic). BILAG A represents the most active disease or severe disease; BILAG B represents intermediate activity or moderate disease; BILAG C represents stable mild disease; BILAG D represents organ system previously affected but now inactive; and BILAG E represents organ system never involved. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 9 domains. The theoretical range spans from 0 (no activity) to 13 active or severe disease activity BILAG. A higher score means more severe disease activity while a lower score means lower disease activity (or no disease activity for score of zero).
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Title
Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt
Description
The pericardial/pleuritic pain scale was scored using numerical values of 1 through 10 with 1 representing 'no pain' and 10 representing 'worst possible pain'. These were self-administered by the participants and gauged the severity of their SLE pain related to pericardial and pleuritic discomfort. Any indication from participants or study assessments, aside from pain, which indicated clinically significant pericardial or pleuritic manifestations of SLE was thoroughly investigated; if clinically significant SLE related complications were found, the participants was to be discontinued from the study and entered into the Observational Follow-up Period and treated appropriately.
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Title
Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point
Description
The Fatigue VAS evaluates SLE-related fatigue using a 0 to 100 mm VAS scale. The Fatigue VAS allowed the participant to indicate the degree of SLE-related fatigue by placing an "X" representing how they feel, along a visual analog line that extends between two extremes (e.g., from not at all tired to extremely tired) over the previous week. A decrease in the fatigue VAS indicates improvement.
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Title
Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point
Description
The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Title
Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point
Description
SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.
Time Frame
Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Part 1 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 been treated with intra-articular, intramuscular or IV pulse corticosteroids within 4 weeks of screening. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shimon Korish, M.D.
Organizational Affiliation
Celgene
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
University of Arizona Clinical and Translational Science Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UCSD Center for Innovative Therapy
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
East Bay Rheumatology Medical Group Inc.
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Los Angeles Biomedical Research Institute at Harbor - UCLA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Inland Rheumatology Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Vipul Joshi, MD, PA, dba Bay Area Arthritis and Osteoporosis
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Advanced Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Arthritis Research and Treatment Center
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Northwestern Medical Group; Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northshore University Health System
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Northwell Health / Division of Rheumatology
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Feinstein Institute For Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032-370
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
DJL Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
MetroHealth Medical Systems
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
University of Pennsylvania Health Systems
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UMPC Lupus Center of Excellence
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Low Country Rheumatology PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Seattle Arthritis Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33687069
Citation
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.
Results Reference
derived

Learn more about this trial

A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.

We'll reach out to this number within 24 hrs