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

NCT02185040 | Completed Phase 2 Results

• 1 other identifier: CC-220-SLE-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 35

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Lupus, Systemic Lupus, SLE

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• 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.

  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 Outcomes (15)

• Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide

  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.

• Maximum Observed Concentration (Cmax) Of Iberdomide

  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.

• Time to Reach Maximum Concentration (Tmax) of Iberdomide

  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.

• Terminal Phase Half-Life (T1/2) Of Iberdomide

  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.

• 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

  Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.

Study Arms (5)

CC-220 0.3mg Every Other Day (QOD)

EXPERIMENTAL

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

Drug: CC-220

CC-220 0.3mg Every Day (QD)

EXPERIMENTAL

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

Drug: CC-220

CC-220 0.6mg/0.3mg alternating dose QD

EXPERIMENTAL

* 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

Drug: CC-220

CC-220 0.6mg QD

EXPERIMENTAL

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

Drug: CC-220

Placebo QD

PLACEBO COMPARATOR

Part 1: Identically matching placebo capsules PO QD

Drug: Placebo

Interventions

CC-220 DRUG

0.3 mg oral capsules once every other day with or without food

CC-220 0.3mg Every Other Day (QOD)

Placebo DRUG

Matching oral placebo daily

Placebo QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (35)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Arthritis and Rheumatology Research, PLLC

Paradise Valley, Arizona, 85253, United States

Location

University of Arizona Clinical and Translational Science Research Center

Tucson, Arizona, 85724, United States

Location

UCSD Center for Innovative Therapy

La Jolla, California, 92037, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

East Bay Rheumatology Medical Group Inc.

San Leandro, California, 94578, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Los Angeles Biomedical Research Institute at Harbor - UCLA

Torrance, California, 90502, United States

Location

Inland Rheumatology Clinical Trials

Upland, California, 91786, United States

Location

Vipul Joshi, MD, PA, dba Bay Area Arthritis and Osteoporosis

Brandon, Florida, 33511, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Advanced Medical Research

Atlanta, Georgia, 30342, United States

Location

Arthritis Research and Treatment Center

Stockbridge, Georgia, 30281, United States

Location

Northwestern Medical Group; Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Northshore University Health System

Skokie, Illinois, 60077, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Northwell Health / Division of Rheumatology

Lake Success, New York, 11042, United States

Location

Feinstein Institute For Medical Research

Manhasset, New York, 11030, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 10032-370, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

DJL Clinical Research

Charlotte, North Carolina, 28210, United States

Location

MetroHealth Medical Systems

Cleveland, Ohio, 44109, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43230, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

University of Pennsylvania Health Systems

Philadelphia, Pennsylvania, 19104, United States

Location

UMPC Lupus Center of Excellence

Pittsburgh, Pennsylvania, 15261, United States

Location

Low Country Rheumatology PA

Charleston, South Carolina, 29406, United States

Location

Austin Regional Clinic

Austin, Texas, 78731, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Seattle Arthritis Clinic

Seattle, Washington, 98133, United States

Location

Related Publications (1)

• 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.

  PMID: 33687069 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

iberdomide

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
• Organization: Celgene Corporation

ClinicalTrialDisclosure@Celgene.com

866-260-1599

Study Officials

• Shimon Korish, M.D.

  Celgene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 9, 2014
• Study Start: September 16, 2014
• Primary Completion: September 25, 2018
• Study Completion: September 25, 2018
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Locations

US (35)