Trial record 8 of 439 for:
lupus
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
This study has been completed.
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01300208
First received: October 18, 2010
Last updated: March 26, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.
| Condition | Intervention | Phase |
|---|---|---|
|
Cutaneous Lupus Erythematosus |
Drug: CC-11050 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Pilot, Multicenter, Sequential, Ascending Dose Study to Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Laboratory values from chemistry, hematology, urinalysis, inflammation/immunology panel that reveal clinically significant abnormalities and that may constitute a safety concern [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]To describe the area under the curve (AUC) of CC-11050 and M15 in plasma
- 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]To describe the peak serum concentration (Cmax) of CC-11050 and M15 in plasma
- Pharmacokinetics [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]To describe the time after administration of a drug when the maxiumum plasma concentration is reached (tmax) of CC-11050 and M15 in plasma
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]To describe the half life (t1/2) of CC-11050 and M15 in plasma
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]To describe the oral clearance (CL/F) of CC-11050 and M15 in plasma
- Pharmacokinetics (PK) [ Time Frame: Up to 21 weeks ] [ Designated as safety issue: No ]To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma
| Enrollment: | 48 |
| Study Start Date: | October 2010 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
CC-11050 (50 milligrams twice per day and Placebo)
|
Drug: CC-11050
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
|
|
Experimental: Cohort 2
CC-11050 (100 milligrams twice per day and Placebo)
|
Drug: CC-11050
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
|
|
Experimental: Cohort 3
CC-11050 (200 milligrams twice per day and Placebo)
|
Drug: CC-11050
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- 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
- Hemoglobin > 11 g/dL Key Exclusion Criteria
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300208
Locations
| United States, Arkansas | |
| Northwest Arkansas Clinical Trials Center, PLLC | |
| Rogers, Arkansas, United States, 72758 | |
| United States, California | |
| Dermatology Research Associates | |
| Los Angeles, California, United States, 90045 | |
| Medderm Associates | |
| San Diego, California, United States, 92103 | |
| United States, Georgia | |
| Emory Univ. School of Medicine | |
| Atlanta, Georgia, United States, 30322 | |
| Peachtree Dermatology Associates Research Center | |
| Atlanta, Georgia, United States, 30327 | |
| Central Medaphase Inc | |
| Newnan, Georgia, United States, 30263 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Dawes Fretzin Clinical Research Group, LLC | |
| Indianapolis, Indiana, United States, 46256 | |
| United States, Kentucky | |
| DermResearch, PLLC | |
| Louisville, Kentucky, United States, 40217 | |
| United States, Louisiana | |
| Dermatology & Advanced Aesthetics | |
| Lake Charles, Louisiana, United States, 70605 | |
| United States, Missouri | |
| Central Dermatology, P.C. | |
| St. Louis, Missouri, United States, 63117 | |
| United States, New York | |
| NYU Langone Medical Center | |
| New York, New York, United States, 10016 | |
| United States, Ohio | |
| University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Penn State Hershey Dermatology | |
| Hershey, Pennsylvania, United States, 17033 | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Clinical Partners, LLC | |
| Johnston, Rhode Island, United States, 02919 | |
| United States, Texas | |
| UT Southwestern Medical Center Dallas | |
| Dallas, Texas, United States, 75390-9090 | |
Sponsors and Collaborators
Celgene Corporation
Investigators
| Study Director: | Tong Li, MD | Celgene Corporation |
More Information
No publications provided
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT01300208 History of Changes |
| Other Study ID Numbers: | CC-11050-CLE-002 |
| Study First Received: | October 18, 2010 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Celgene Corporation:
|
cutaneous lupus erythematosus subacute lupus erythematosus discoid lupus erythematosus lupus |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus, Systemic Connective Tissue Diseases |
Skin Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013