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Clinical Trial Details

Overview

Research Study Summary

A clinical research study of R932333 and Placebo for the treatment of Lupus Erythematosus, Discoid or Lupus Erythematosus, Systemic

Research Study 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

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.

To Learn more
Phase

2

Gender

Both Male and Female

Age

18 to 75 Years

Overall Status

Recruiting

Lead Sponsor

Rigel Pharmaceuticals

Duration

13 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years to 75 Years

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.

Site Locations (15)

Country State City Zip Facility and Contact
United States California Los Angeles 90027 Wallace Rheumatic Study Center
Daniel Wallace, MD
310-360-9197

Daniel Wallace, MD
Principal Investigator
United States California Redwood City 94063 Stanford Dermatology
David Fiorentino, MD
650-721-7147

David Fiorentino, MD
Principal Investigator
United States Indiana South Bend 46601 Memorial Medical Group Clinical Research Institute
Nicholas Straniero, MD
574-647-7883

Nicholas Straniero, MD
Principal Investigator
United States New York Lake Success 11042 North Shore Long Island Health System
Richard Furie, MD
516-708-2557

Richard Furie, MD
Principal Investigator
United States New York New York 10032 Columbia University Medical Center
Julian Mackay-Wiggan, MD
212-305-5293

Julian Mackay-Wiggan, MD
Principal Investigator
United States North Carolina Winston-Salem 27104 Wake Forest University Health Sciences
Joseph Jorizzo, MD
336-716-3775

Joseph Jorizzo, MD
Principal Investigator
United States Oklahoma Oklahoma City 73104 Oklahoma Medical Research Foundation
Joan Merrill, MD
405-271-7805

Joan Merrill, MD
Principal Investigator
United States Pennsylvania Philadelphia 19104 University of Pennsylvania-Dermatology Research Office
Victoria Werth, MD
215-898-0168

Victoria Werth, MD
Principal Investigator
United States Texas Dallas 75231 Metroplex Clinical Research Center
Stanley Cohen, MD
214-424-0401

Stanley Cohen, MD
Principal Investigator
United States Texas Houston 77030 University of Texas Medical School at Houston
Adelaide Herbert, MD
713-500-8260

Adelaide Hebert, MD
Principal Investigator
United States Utah Salt Lake City 84132 University of Utah Department of Dermatology
Christopher Hansen, MD
801-581-6477

Christopher Hansen, MD
Principal Investigator
United States Virginia Norfolk 23507 Virginia Clinical Research, Inc
David Pariser, MD
757-625-0151

David Pariser, MD
Principal Investigator
Canada British Columbia Vancouver V5Z 4E8 University of British Columbia, Vancouver Dermatology Clinical Trials Unit
Jan Dutz, MD
604-875-5296

Jan Dutz, MD
Principal Investigator
Canada Manitoba Winnipeg R3C 1R4 Dermadvances Research
Jack Toole, MD
204-947-1630

Jack Toole, MD
Principal Investigator
Canada Ontario Markham L3P 1A8 Lynderm Research, Inc
Charles Lynde, MD
905-471-8011

Charles Lynde, MD
Principal Investigator

Contact

Daniel Magilavy, M.D.
650-624-1372

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01597050

Date Last Changed: August 17, 2012

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