NCT01300208

Brief Summary

This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

2.3 years

First QC Date

October 18, 2010

Last Update Submit

June 18, 2020

Conditions

Cutaneous Lupus Erythematosus

Keywords

cutaneous lupus erythematosussubacute lupus erythematosusdiscoid lupus erythematosuslupus

Outcome Measures

Primary Outcomes (1)

  • Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern

    Up to 21 weeks

Secondary Outcomes (8)

  • Pharmacokinetics (PK)

    Up to 21 weeks

  • To assess the clinical response rate of CC-11050 in subjects with discoid lupus erythematosus or sub acute lupus erythematosus using the Cutaneous Lupus Area and Severity Index Activity Score following 12-weeks of treatment

    12 weeks

  • Pharmacokinetics (PK)

    Up to 21 weeks

  • Pharmacokinetics

    Up to 21 weeks

  • Pharmacokinetics (PK)

    Up to 21 weeks

  • +3 more secondary outcomes

Study Arms (3)

Cohort 1

EXPERIMENTAL

CC-11050 (50 milligrams twice per day and Placebo)

Drug: CC-11050Other: Placebo

Cohort 2

EXPERIMENTAL

CC-11050 (100 milligrams twice per day and Placebo)

Drug: CC-11050Other: Placebo

Cohort 3

EXPERIMENTAL

CC-11050 (200 milligrams twice per day and Placebo)

Drug: CC-11050Other: Placebo

Interventions

CC-11050DRUG

Cohort 1: 50 milligrams twice per day for 4 weeks Cohort 2: 100 milligrams twice per day for 8 weeks Cohort 3: 200 milligrams twice per day for 12 week

Cohort 1Cohort 2Cohort 3
PlaceboOTHER
Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with a clinical diagnosis of discoid lupus erythematosus or sub acute lupus erythematosus for \> 16 weeks prior to screening and consistent histological findings on skin biopsy based on Gilliam classification who are candidates for systemic therapies (as determined by the Investigator)
  • Must, in the opinion of the Investigator, have active skin lesions of sufficient severity at Screening and Baseline (a Cutaneous Lupus Area and Severity Index Activity Score of ≥ 10)
  • All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study must have documentation of an ophthalmologic exam performed within 24 weeks of the Baseline Visit.
  • Must meet the following laboratory criteria:
  • White blood cell count ≥3000/mm3 (≥ 3.0 x 109/L) and \< 14,000/mm3 (\< 14 x 109/L)
  • Absolute neutrophil count (ANC) \> 1500 cells/μL (1.5 x 109/L)
  • Platelet count ≥ 100,000/μL (≥ 100 x 109/L)
  • Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
  • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT)
  • ≤ 1.5 X upper limit of normal (ULN)
  • Total bilirubin \< 2mg/dL

You may not qualify if:

  • Participation in multiple CC-11050 cohorts or previous exposure to CC-11050
  • Presence or history of SLE based on investigators' clinical evaluation where subject exhibits medically significant (as determined by the Investigator) LE-related pleuritis, pericarditis, neurologic, renal and/or other major SLE-related organ system involvement(SLE-related to SLE joint involvement is acceptable).
  • Use of topical or any local therapy known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening Visit
  • Use of concomitant disease modifying anti-rheumatic drugs (DMARDs) with the exception of anti-malarials within 4 weeks of screening- Use of topical or any local therapy known to possibly benefit discoid lupus erythematosus or SCLE sub acute lupus erythematosus within 2 weeks of the Screening Visit
  • Use of immunosuppressives (eg, azathioprine, mycophenolate mofetil, methotrexate, etc.) within 4 weeks of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Northwest Arkansas Clinical Trials Center, PLLC

Rogers, Arkansas, 72758, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Medderm Associates

San Diego, California, 92103, United States

Location

Emory Univ. School of Medicine

Atlanta, Georgia, 30322, United States

Location

Peachtree Dermatology Associates Research Center

Atlanta, Georgia, 30327, United States

Location

Central Medaphase Inc

Newnan, Georgia, 30263, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

Dermatology & Advanced Aesthetics

Lake Charles, Louisiana, 70605, United States

Location

Central Dermatology, P.C.

St Louis, Missouri, 63117, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Penn State Hershey Dermatology

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

UT Southwestern Medical Center Dallas

Dallas, Texas, 75390-9090, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, CutaneousLupus Erythematosus, Discoid

Interventions

CC-11050

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

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

October 18, 2010

First Posted

February 21, 2011

Study Start

October 1, 2010

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations

US(19)