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CompletedNCT01597050SKINDLEUpdated Jul 14, 2016Results posted

Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions

A Phase 2 interventional study of R932333 and Placebo in Lupus Erythematosus, Discoid and Lupus Erythematosus, Systemic, sponsored by Rigel Pharmaceuticals. Completed at 15 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-07-14.

Sponsored by Rigel Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Lupus Erythematosus, Discoid
  • Lupus Erythematosus, Systemic

Keywords

  • Discoid Lupus Erythematosus
  • Systemic Lupus Erythematosus
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 54 is close to the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Rigel Pharmaceuticals is the lead sponsor of 27 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    Drug: R932333

    R333 6% (60 mg/g), bid

    Drug: R932333

  • Placebo comparator
    Placebo

    Placebo, bid

    Drug: Placebo

Interventions

  • DrugR932333

    R393233 6% (60 mg/g), bid

    Also known as: R333

  • DrugPlacebo

    Placebo, bid

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted Jun 8, 2016

Participant flow

Participant flow — Overall Study
MilestoneDrug: R932333Placebo
Started3618
Completed3518
Not completed10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryDecrease 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
Reported as:
Number · percentage of subjects
Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.
percentage of subjectsDrug: R932333Placebo
Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.22.227.8

Adverse events

Collected over The AE reporting period begins with the first dose of double blind study drug and ends with the final study (follow-up) visit at week 6.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Drug: R932333—0/36 (0%)16/36 (44.4%)
Placebo—0/18 (0%)10/18 (55.6%)
Most frequent other events
Showing 10 of 35
Most frequent other events
EventDrug: R932333Placebo
Upper Respiratory Track InfectionInfections and infestations3/363/18
VomitingGastrointestinal disorders4/360/18
PruritusSkin and subcutaneous tissue disorders1/362/18
SinusitisInfections and infestations0/362/18
Skin lesionSkin and subcutaneous tissue disorders0/362/18
HeadacheNervous system disorders3/361/18
Sinus congestionRespiratory, thoracic and mediastinal disorders3/360/18
Application site painGeneral disorders1/361/18
LeukopeniaBlood and lymphatic system disorders0/361/18
Musculoskeletal painMusculoskeletal and connective tissue disorders0/361/18

Baseline characteristics

Age, Continuous
Age, Continuous(years)Drug: R932333PlaceboTotal
Mean46.1 ± 11.348.3 ± 12.5746.8 ± 11.69
Sex: Female, Male
Sex: Female, Male(Participants)Drug: R932333PlaceboTotal
Female281644
Male8210
Region of Enrollment
Region of Enrollment(participants)Drug: R932333PlaceboTotal
Canada729
United States291645
08

Study locations

15 sites
  • Wallace Rheumatic Study Center
    Los Angeles, California 90027, United States
  • Stanford Dermatology
    Redwood City, California 94063, United States
  • Memorial Medical Group Clinical Research Institute
    South Bend, Indiana 46601, United States
  • North Shore Long Island Health System
    Lake Success, New York 11042, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27104, United States
  • Oklahoma Medical Research Foundation
    Oklahoma City, Oklahoma 73104, United States
  • University of Pennsylvania-Dermatology Research Office
    Philadelphia, Pennsylvania 19104, United States
  • Metroplex Clinical Research Center
    Dallas, Texas 75231, United States
  • University of Texas Medical School at Houston
    Houston, Texas 77030, United States
  • University of Utah Department of Dermatology
    Salt Lake City, Utah 84132, United States
  • Virginia Clinical Research, Inc
    Norfolk, Virginia 23507, United States
  • University of British Columbia, Vancouver Dermatology Clinical Trials Unit
    Vancouver, British Columbia V5Z 4E8, Canada
  • Dermadvances Research
    Winnipeg, Manitoba R3C 1R4, Canada
  • Lynderm Research, Inc
    Markham, Ontario L3P 1A8, Canada
09

References and documents

Publications

  • 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. PubMed 33687069 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01597050
Lead sponsor
Rigel Pharmaceuticals
Responsible party
Sponsor
First posted
May 11, 2012
Start date
Aug 2012
Primary completion
Sep 2013
Completion
Sep 2013
Results posted
Jun 8, 2016
Last update
Jul 14, 2016

Study contacts

Daniel Magilavy, MD
study director · Rigel Pharmaceuticals,Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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