Clinical trial NCT01597050: Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Keywords: Discoid Lupus Erythematosus
Systemic Lupus Erythematosus
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-05-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.
timeFrame: Up to Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Redwood City
country: United States
facility: Stanford Dermatology
state: California
city: South Bend
country: United States
facility: Memorial Medical Group Clinical Research Institute
state: Indiana
city: Lake Success
country: United States
facility: North Shore Long Island Health System
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania-Dermatology Research Office
state: Pennsylvania
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: University of Texas Medical School at Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Department of Dermatology
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
city: Vancouver
country: Canada
facility: University of British Columbia, Vancouver Dermatology Clinical Trials Unit
state: British Columbia
city: Winnipeg
country: Canada
facility: Dermadvances Research
state: Manitoba
city: Markham
country: Canada
facility: Lynderm Research, Inc
state: Ontario
Study officials:
affiliation: Rigel Pharmaceuticals,Inc.
name: Daniel Magilavy, MD
role: STUDY_DIRECTOR
References:
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.