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Trial record 25 of 698 for:    lupus

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02185040
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: CC-220 Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 16, 2014
Actual Primary Completion Date : September 25, 2018
Actual Study Completion Date : September 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: CC-220 0.3mg Every Other Day (QOD)
Part 1: CC-220 0.3mg capsules by mouth every other day (QOD)
Drug: CC-220
0.3 mg oral capsules once every other day with or without food

Experimental: 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)
Drug: CC-220
Subjects will receive 0.3 mg oral capsules every day with or without food

Experimental: 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
Drug: CC-220
CC-220 oral capsules 0.6 mg and 0.3 mg on alternating days with or without food

Experimental: CC-220 0.6mg QD
Part 1: CC-220 0.6mg capsules by mouth QD
Drug: CC-220
CC-220 oral capsule 0.6 mg QD with or without food

Placebo Comparator: Placebo QD
Part 1: Identically matching placebo capsules PO QD
Drug: Placebo
Matching oral placebo daily




Primary Outcome Measures :
  1. Type, Frequency , Severity and Relationship of Adverse Events to CC-220 Part 1 [ Time Frame: Up to 84 days ]
    Number of participants with adverse events; An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. Adverse events and serious adverse events (SAEs) will be assessed and recorded from the time the subject signs the Informed Consent Document (ICD) until study completion, and when made known to the Investigator within 28 days after the last dose of investigational product (IP) (and those SAEs made known to the Investigator at any time thereafter that are suspected of being related to IP

  2. Type, Frequency , severity and relationship of Adverse Events to CC-220 ATEP [ Time Frame: Up to 25 Months ]
    Number of participants with adverse events; An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. Adverse events and serious adverse events (SAEs) will be assessed and recorded from the time the subject signs the Informed Consent Document (ICD) until study completion, and when made known to the Investigator within 28 days after the last dose of investigational product (IP) (and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP.


Secondary Outcome Measures :
  1. Pharmacokinetics - Cmax (Part 1) [ Time Frame: Day 1, 15, 29, 57 and 85 ]
    Maximum observed in concentration plasma

  2. Pharmacokinetics - Cmin (Part 1) [ Time Frame: Day 1, 15, 29, 57 and 85 ]
    Maximum observed in concentration plasma.

  3. Pharmacokinetics - AUC -t (Part 1) [ Time Frame: Day 1, 15, 29, 57 and 85 ]
    Area under the plasma concentration time-curve

  4. Pharmacokinetics - AUC - τ (Part 1) [ Time Frame: Day 1, 15, 29, 57 and 85 ]
    Area under the plasma concentration time-curve

  5. Pharmacokinetics - AUC - infinity (Part 1) [ Time Frame: Day 1, 15, 29, 57 and 85 ]
    Area under the plasma concentration time-curve

  6. Pharmacokinetics - Terminal Half Life (T1/2 Part 1) [ Time Frame: Day 1, 15, 29, 57 and 85 ]
    Terminal phase half-life (T1/2)

  7. Pharmacokinetics - Volume of Distribution (Vz/f Part 1) [ Time Frame: Day 1, 15, 29, 57 and 85 ]
    Apparent volume of distribution

  8. Pharmacokinetics - Apparent total body clearance (CL/F Part 1) [ Time Frame: Day 1, 15, 29, 57 and 85 ]
    : Apparent total body clearance

  9. Pharmacokinetics - Tmax (Part 1) [ Time Frame: Day 1, 15, 29, 57 and 85 ]
    Time to first maximum observed plasma concentration

  10. Hybrid SELENA SLEDAI ATEP [ Time Frame: Up to approximately 25 months ]
    Change in Hybrid SELENA SLEDAI by ≥ 4 units by visit.

  11. Hybrid SELENA SLEDAI ATEP [ Time Frame: Up to approximately 25 months ]
    Change in Hybrid SELENA SLEDAI by visit.

  12. Swollen and Tender Joint Count Score ATEP [ Time Frame: Up to approximately 25 months ]
    Change in Swollen and Tender Joint Count Score by visit.

  13. CLASI Activity score ATEP [ Time Frame: Up to approximately 25 months ]
    Change in CLASI activity score by visit.

  14. PGA ATEP [ Time Frame: Up to approximately 25 months ]
    Change in PGA by visit.

  15. BILAG 2004 ATEP [ Time Frame: Up to approximately 25 months ]
    Change in BILAG 2004 by visit.

  16. Pericardial/Pleuritic Pain Scale ATEP [ Time Frame: Up to approximately 25 months ]
    Change in Pericardial/Pleuritic Pain Scale by visit.

  17. Fatigue VAS ATEP [ Time Frame: Up to approximately 25 months ]
    Change Fatigue VAS by visit

  18. CLASI Damage ATEP [ Time Frame: Up to approximately 25 months ]
    Change in CLASI Damage by visit

  19. SLICC/ACR SLE Damage Index ATEP [ Time Frame: Up to approximately 25 months ]
    Change in SLICC/ACR SLE Damage Index by visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
    • Subjects taking hydroxychloroquine, chloroquine and/or quinacrine are required to use the medication for 16 weeks prior to their screening visit and be on a stable dose for at least 4 weeks prior to first dose of IP and throughout the study. Hydroxychloroquine ≤ 6.5 mg/kg of ideal body weight daily or equivalent (chloroquine [≤ 4 mg/kg of ideal body weight daily] or quinacrine [≤ 100 mg daily]) will be permitted.
    • 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.

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): NCT02185040


  Show 34 Study Locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Marla Hochfeld, M.D. Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02185040     History of Changes
Other Study ID Numbers: CC-220-SLE-001
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018

Keywords provided by Celgene:
Lupus, Systemic Lupus, SLE

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases