Trial record 3 of 140 for:
Open Studies | "Lupus Erythematosus, Systemic"
Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions (SKINDLE)
This study is currently recruiting participants.
Verified August 2012 by Rigel Pharmaceuticals
Sponsor:
Rigel Pharmaceuticals
Information provided by (Responsible Party):
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01597050
First received: May 9, 2012
Last updated: August 17, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
| Estimated Enrollment: | 54 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597050
Contacts
| Contact: Daniel Magilavy, M.D. | 650-624-1372 | dmagilavy@rigel.com |
Locations
| United States, California | |
| Wallace Rheumatic Study Center | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Daniel Wallace, MD 310-360-9197 | |
| Principal Investigator: Daniel Wallace, MD | |
| Stanford Dermatology | Recruiting |
| Redwood City, California, United States, 94063 | |
| Contact: David Fiorentino, MD 650-721-7147 | |
| Principal Investigator: David Fiorentino, MD | |
| United States, Indiana | |
| Memorial Medical Group Clinical Research Institute | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: Nicholas Straniero, MD 574-647-7883 | |
| Principal Investigator: Nicholas Straniero, MD | |
| United States, New York | |
| North Shore Long Island Health System | Recruiting |
| Lake Success, New York, United States, 11042 | |
| Contact: Richard Furie, MD 516-708-2557 | |
| Principal Investigator: Richard Furie, MD | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Julian Mackay-Wiggan, MD 212-305-5293 | |
| Principal Investigator: Julian Mackay-Wiggan, MD | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27104 | |
| Contact: Joseph Jorizzo, MD 336-716-3775 | |
| Principal Investigator: Joseph Jorizzo, MD | |
| United States, Oklahoma | |
| Oklahoma Medical Research Foundation | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Joan Merrill, MD 405-271-7805 | |
| Principal Investigator: Joan Merrill, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania-Dermatology Research Office | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Victoria Werth, MD 215-898-0168 | |
| Principal Investigator: Victoria Werth, MD | |
| United States, Texas | |
| Metroplex Clinical Research Center | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact: Stanley Cohen, MD 214-424-0401 | |
| Principal Investigator: Stanley Cohen, MD | |
| University of Texas Medical School at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Adelaide Herbert, MD 713-500-8260 | |
| Principal Investigator: Adelaide Hebert, MD | |
| United States, Utah | |
| University of Utah Department of Dermatology | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Christopher Hansen, MD 801-581-6477 | |
| Principal Investigator: Christopher Hansen, MD | |
| United States, Virginia | |
| Virginia Clinical Research, Inc | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: David Pariser, MD 757-625-0151 | |
| Principal Investigator: David Pariser, MD | |
| Canada, British Columbia | |
| University of British Columbia, Vancouver Dermatology Clinical Trials Unit | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E8 | |
| Contact: Jan Dutz, MD 604-875-5296 | |
| Principal Investigator: Jan Dutz, MD | |
| Canada, Manitoba | |
| Dermadvances Research | Recruiting |
| Winnipeg, Manitoba, Canada, R3C 1R4 | |
| Contact: Jack Toole, MD 204-947-1630 | |
| Principal Investigator: Jack Toole, MD | |
| Canada, Ontario | |
| Lynderm Research, Inc | Recruiting |
| Markham, Ontario, Canada, L3P 1A8 | |
| Contact: Charles Lynde, MD 905-471-8011 | |
| Principal Investigator: Charles Lynde, MD | |
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: | August 17, 2012 |
| 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, Discoid Lupus Erythematosus, Systemic Lupus Erythematosus, Cutaneous Connective Tissue Diseases |
Skin Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013