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: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Drug: R932333
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rigel Pharmaceuticals:

Primary Outcome Measures:
  • Decrease in the total combined Erythema and Scaling score of all treated lesions. [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Drug: R932333
R333 6% (60 mg/g), bid
Drug: R932333
R393233 6% (60 mg/g), bid
Other Name: R333
Placebo Comparator: Placebo
Placebo, bid
Drug: Placebo
Placebo, bid
Other Name: Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597050

Locations
United States, California
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90027
Stanford Dermatology
Redwood City, California, United States, 94063
United States, Indiana
Memorial Medical Group Clinical Research Institute
South Bend, Indiana, United States, 46601
United States, New York
North Shore Long Island Health System
Lake Success, New York, United States, 11042
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27104
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pennsylvania-Dermatology Research Office
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
University of Texas Medical School at Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah Department of Dermatology
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Clinical Research, Inc
Norfolk, Virginia, United States, 23507
Canada, British Columbia
University of British Columbia, Vancouver Dermatology Clinical Trials Unit
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Manitoba
Dermadvances Research
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, Ontario
Lynderm Research, Inc
Markham, Ontario, Canada, L3P 1A8
Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
Study Director: Daniel Magilavy, MD Rigel Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01597050     History of Changes
Other Study ID Numbers: C-932333-002
Study First Received: May 9, 2012
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Rigel Pharmaceuticals:
Discoid Lupus Erythematosus
Systemic Lupus Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Cutaneous
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014