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Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions (SKINDLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01597050
First received: May 9, 2012
Last updated: June 15, 2016
Last verified: June 2016

May 9, 2012
June 15, 2016
August 2012
September 2013   (final data collection date for primary outcome measure)
Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. [ Time Frame: Up to Week 4 ] [ Designated as safety issue: No ]
Percentage of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. A decrease is an improvement in measurement of erythema and scaling of the lesions.
Decrease in the Total Combined Erythema and Scaling Score of All Treated Lesions. [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01597050 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid Lesions
The purpose of this study is to determine the safety, efficacy and tolerability of topical R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) patients with active discoid lesions.
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the preliminary efficacy, safety, tolerability, and pharmacokinetics of topical R333 ointment formulated at 6% (60 mg/g) in DLE and SLE patients with active discoid lesions.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Lupus Erythematosus, Discoid
  • Lupus Erythematosus, Systemic
  • Drug: R932333
    R393233 6% (60 mg/g), bid
    Other Name: R333
  • Drug: Placebo
    Placebo, bid
  • Active Comparator: Drug: R932333
    R333 6% (60 mg/g), bid
    Intervention: Drug: R932333
  • Placebo Comparator: Placebo
    Placebo, bid
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of SLE or DLE (DLE confirmed histologically prior to randomization).
  • At least 2 active discoid lesions secondary to SLE or DLE prior to study entry, each with a minimum Erythema Rating Score of ≥ 2. At least 1 of the active discoid lesions must have been present (by history) for ≥ 3 weeks prior to screening.
  • Patients who are taking azathioprine, hydroxychloroquine, chloroquine, quinacrine, methotrexate, and/ or oral glucocorticoids, must be receiving a stable daily dose ≥ 4 weeks prior to randomization and must remain on the same dose throughout the study. Azathioprine, hydroxychloroquine, chloroquine, quinacrine, or methotrexate must be initiated ≥ 8 weeks prior to randomization.

Exclusion Criteria:

  • Congenital or acquired immunodeficiency including: HIV infection, agammaglobulinemias, T cell deficiencies or HTLV-1 infection at any time prior to the study.
  • Lymphoproliferative disease or previous total lymphoid irradiation.
  • Uncontrolled or poorly controlled hypertension.
  • History of psoriasis, eczema, or relevant atopy.
  • Exposure to excessive or chronic UV radiation (e.g., tanning beds, sunbathing, solarium, phototherapy) within 2 weeks prior to randomization or during the study period.
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01597050
C-932333-002
No
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Rigel Pharmaceuticals
Rigel Pharmaceuticals
Not Provided
Study Director: Daniel Magilavy, MD Rigel Pharmaceuticals, Inc.
Rigel Pharmaceuticals
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP