Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic
Conditions
Keywords
Discoid Lupus Erythematosus, Systemic Lupus Erythematosus
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.
Interventions
DRUGR932333
R393233 6% (60 mg/g), bid
DRUGPlacebo
Placebo, bid
Sponsors
Rigel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drug: R932333 R333 6% (60 mg/g), bid
R932333: R393233 6% (60 mg/g), bid | 36 |
| Placebo Placebo, bid
Placebo: Placebo, bid | 18 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Drug: R932333 |
|---|---|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 12.57 | 46.8 years STANDARD_DEVIATION 11.69 | 46.1 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment Canada | 2 participants | 9 participants | 7 participants |
| Region of Enrollment United States | 16 participants | 45 participants | 29 participants |
| Sex: Female, Male Female | 16 Participants | 44 Participants | 28 Participants |
| Sex: Female, Male Male | 2 Participants | 10 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 36 | 10 / 18 |
| serious Total, serious adverse events | 0 / 36 | 0 / 18 |
Outcome results
Primary
Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.
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.
Time frame: Up to Week 4
Population: Per-protocol population all patients who had no major protocol deviations and were present at all scheduled visits up to and including Week 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Drug: R932333 | Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. | 22.2 percentage of subjects |
| Placebo | Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. | 27.8 percentage of subjects |