To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus

Cutaneous Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300208
• Other study ID #: CC-11050-CLE-002
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2010
• Est. completion date: March 1, 2013

Study information

• Verified date: June 2020
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 1, 2013
• Est. primary completion date: January 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Lupus Erythematosus
• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic

Intervention

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

Other:
• Placebo

Locations

Country	Name	City	State
United States	Emory Univ. School of Medicine	Atlanta	Georgia
United States	Peachtree Dermatology Associates Research Center	Atlanta	Georgia
United States	Northwestern University	Chicago	Illinois
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	UT Southwestern Medical Center Dallas	Dallas	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Penn State Hershey Dermatology	Hershey	Pennsylvania
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Dermatology & Advanced Aesthetics	Lake Charles	Louisiana
United States	Dermatology Research Associates	Los Angeles	California
United States	DermResearch, PLLC	Louisville	Kentucky
United States	NYU Langone Medical Center	New York	New York
United States	Central Medaphase Inc	Newnan	Georgia
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Northwest Arkansas Clinical Trials Center, PLLC	Rogers	Arkansas
United States	Central Dermatology, P.C.	Saint Louis	Missouri
United States	Medderm Associates	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK)	To describe the area under the curve (AUC) of CC-11050 and M15 in plasma	Up to 21 weeks
Secondary	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
Secondary	Pharmacokinetics (PK)	To describe the peak serum concentration (Cmax) of CC-11050 and M15 in plasma	Up to 21 weeks
Secondary	Pharmacokinetics	To describe the lowest serum concentration (Cmin)of CC-11050 and M15 in plasma	Up to 21 weeks
Secondary	Pharmacokinetics (PK)	To describe the time after administration of a drug when the maxiumum plasma concentration is reached (tmax) of CC-11050 and M15 in plasma	Up to 21 weeks
Secondary	Pharmacokinetics (PK)	To describe the half life (t1/2) of CC-11050 and M15 in plasma	Up to 21 weeks
Secondary	Pharmacokinetics (PK)	To describe the oral clearance (CL/F) of CC-11050 and M15 in plasma	Up to 21 weeks
Secondary	Pharmacokinetics (PK)	To describe the volume of distribution (Vz/F) of CC-11050 and M15 in plasma	Up to 21 weeks