Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01597050 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
A Phase 2 study of Lupus Erythematosus, Systemic and Lupus Erythematosus, Discoid, sponsored by Rigel Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 15
- Study locations
NCT01597050: Completed Phase 2 study of Lupus Erythematosus, Systemic and Lupus Erythematosus, Discoid, sponsored by Rigel Pharmaceuticals.
NCT01597050 is a Phase 2 study of Lupus Erythematosus, Systemic and Lupus Erythematosus, Discoid that has completed, run by Rigel Pharmaceuticals. The registered enrollment target is 54 participants, below the 201-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (73% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01597050, a Phase 2 study of Lupus Erythematosus, Systemic and Lupus Erythematosus, Discoid, has completed, sponsored by Rigel Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG R932333
Study Locations (15)
California
- Wallace Rheumatic Study Center - Los Angeles
- Stanford Dermatology - Redwood City
New York
- North Shore Long Island Health System - Lake Success
- Columbia University Medical Center - New York
Texas
- Metroplex Clinical Research Center - Dallas
- University of Texas Medical School at Houston - Houston
Indiana
- Memorial Medical Group Clinical Research Institute - South Bend
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Oklahoma
- Oklahoma Medical Research Foundation - Oklahoma City
Pennsylvania
- University of Pennsylvania-Dermatology Research Office - Philadelphia
Utah
- University of Utah Department of Dermatology - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT01597050 record still lists
NCT01597050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 201-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01597050 lists 15 locations in 12 states (California, New York, Texas).
Frequently Asked Questions
What is clinical trial NCT01597050 about?
NCT01597050 is a clinical study titled "Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions". 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.
What is the current status of trial NCT01597050?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2012-08. Estimated completion is 2013-09.
What conditions does trial NCT01597050 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid.
What interventions are being tested in trial NCT01597050?
The interventions under investigation include: Placebo (DRUG), R932333 (DRUG).
Who is sponsoring clinical trial NCT01597050?
This trial is sponsored by Rigel Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01597050 being conducted?
This trial has 15 study locations across California, Indiana, New York, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lupus Erythematosus, Systemic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01597050's enrollment target sits among peer trials
54 24th of 29 higher than 6 of 29 other Lupus Erythematosus, Systemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Erythematosus, Systemic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
RECRUITING · Phase 2
-
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
RECRUITING · Phase 2
-
Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus
ACTIVE NOT RECRUITING · Phase 2
-
Study of VIB7734 for the Treatment of Moderate to Severely Active SLE
COMPLETED · Phase 2
-
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
COMPLETED · Phase 2
-
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01269853 · 54 participants · Phase 1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
- NCT02390752 · 54 participants · Phase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
- NCT02991248 · 54 participants · NA
Improve Dynamic Lateral Balance of Humans With SCI
- NCT02993900 · 54 participants · NA
Image-Guided Gynecologic Brachytherapy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia