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A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid 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: NCT01466725
Recruitment Status : Terminated (The benefit/risk profile does not support continuation of this study.)
First Posted : November 8, 2011
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.

Condition or disease Intervention/treatment Phase
Discoid Lupus Drug: CC-930 Drug: Placebo Phase 2

Detailed Description:

Enrollment will occur in sequential, ascending, dose-sequence design, where a higher CC-930 dose level and longer duration of dosing (cohort) will not be initiated until supportive safety profile is demonstrated in the preceding cohort. There will be 4 cohorts as described here;

Cohort 1: 25 mg once daily for 4 weeks Cohort 2: 50 mg once daily for 4 weeks Cohort 3: 100 mg once daily for 6 weeks Cohort 4: 100 mg twice daily for 6 weeks

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Pilot, Multicenter, Randomized, Placebo-Controlled Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of CC-930 in Subjects With Recalcitrant Discoid Lupus Erythematosus (DLE)
Actual Study Start Date : November 1, 2011
Actual Primary Completion Date : July 30, 2012
Actual Study Completion Date : July 30, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Cohort 1
25 mg daily for 4 weeks (8 active/2 control)
Drug: CC-930
Drug: Placebo
Placebo

Experimental: Cohort 2
50 mg once daily for 4 weeks (8 active/2 control)
Drug: CC-930
Drug: Placebo
Placebo

Experimental: Cohort 3
100 mg daily for 6 weeks (8 active/2 control)
Drug: CC-930
Drug: Placebo
Placebo

Experimental: Cohort 4
100 mg twice daily for 6 weeks (8 active/2 control)
Drug: CC-930
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: 4 to 6 weeks ]

Secondary Outcome Measures :
  1. To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE. [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female with clinical diagnosis of Discoid Lupus Erythematosus (DLE) aged 18 to 64 years
  2. Good health as assessed by Investigator
  3. DLE for at least 16 weeks prior to screening and consistent histological findings.
  4. Considered a candidate for systemic therapy. May be naïve to systemic therapy or experiencing incomplete or refractory disease on systemic therapy.
  5. Cutaneous Lupus Area and Severity Index (CLASI) activity score of at least 10, as determined by investigator.
  6. Subjects using hydroxychloroquine, chloroquine, or quinacrine must have documented ophthalmologic exam within 24 weeks of baseline visit.
  7. Must meet laboratory criteria for white blood cells, absolute neutrophils, platelets, serum creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin and hemoglobin.
  8. Subjects, male and female, must agree to strict pregnancy prevention and testing requirements.

Exclusion Criteria:

  1. Significant illnesses as determined by physician.
  2. History of significant cardiac conditions or interventions within prior 6 months including abnormal electrocardiogram (ECG) findings.
  3. Systolic blood pressure < 95 or > 150 mm Hg
  4. Diastolic blood pressure > 90 mm Hg.
  5. Pregnancy or breast feeding.
  6. Other dermatological conditions that would interfere with CLASI Activity Score assessments.
  7. History of or active; malignancy, human immunodeficiency virus (HIV), tuberculosis infection, other mycobacterial infection, congenital or acquired immunodeficiency, Hepatitis B and C.
  8. Clinically significant abnormality on chest X-ray.
  9. Participation in multiple CC-930 cohorts.
  10. History of thrombolytic event.
  11. Positive tests for lupus anticoagulant, anti-cardiolipin antibodies, antibodies to beta-2 glycoprotein 1 or phosphatidylserine at screening.
  12. Positive antineutrophilic cytoplasmic antibody (ANCA) at screening.
  13. Diagnosis of SLE.
  14. Presence or history of medically significant Systemic Lupus Erythematosis (SLE) or Lupus Erythematosis (LE) comorbidities.
  15. History of seizures, chorea or psychosis.
  16. Presence or history of persistent proteinuria or urinary cellular casts.
  17. Prohibited prior or concomitant medications.

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): NCT01466725


Locations
Show Show 19 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: William Smith, MD Celgene
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01466725    
Other Study ID Numbers: CC-930-DLE-002
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Keywords provided by Celgene:
Lupus
Discoid Lupus
DLE
Cutaneous Lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Discoid
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Skin Diseases