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:
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01597050
First Posted: May 11, 2012
Last Update Posted: July 14, 2016
Information provided by (Responsible Party):
Rigel Pharmaceuticals
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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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:
Genetics Home Reference related topics:
systemic lupus erythematosus
MedlinePlus related topics:
Lupus
U.S. FDA Resources
Further study details as provided by Rigel Pharmaceuticals:
Primary Outcome Measures:
- 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 ]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.
| Enrollment: | 54 |
| 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
|
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
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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): 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
| Responsible Party: | Rigel Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01597050 History of Changes |
| Other Study ID Numbers: |
C-932333-002 |
| First Submitted: | May 9, 2012 |
| First Posted: | May 11, 2012 |
| Results First Submitted: | April 28, 2016 |
| Results First Posted: | June 8, 2016 |
| Last Update Posted: | July 14, 2016 |
| Last Verified: | June 2016 |
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 |