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



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:September 16, 2014
End Date:September 25, 2018

Use our guide to learn which trials are right for you!

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

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.

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

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.
We found this trial at
34
sites
Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
Beachwood, California 44122
?
mi
from
Beachwood, CA
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Charleston, South Carolina 29406
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28210
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
Los Angeles, California 90045
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
722 W 168th St
New York, New York 10032
(212) 305-2500
Columbia Presbyterian Med Ctr On January 1, 1998, The New York Hospital publicly announced its...
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Paradise Valley, Arizona 85253
?
mi
from
Paradise Valley, AZ
Click here to add this to my saved trials
Philadelphia, Pennsylvania
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
San Leandro, California 94578
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
2001 Santa Monica Boulevard
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Seattle, Washington 98133
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Skokie, Illinois 60077
?
mi
from
Skokie, IL
Click here to add this to my saved trials
327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Stockbridge, Georgia 30281
?
mi
from
Stockbridge, GA
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Torrance, CA
Click here to add this to my saved trials
?
mi
from
Upland, CA
Click here to add this to my saved trials