Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03161483 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 289
- Enrollment target
NCT03161483: Completed Phase 2 study, sponsored by Celgene.
NCT03161483 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 289 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03161483, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 289 participants
- Enrollment target
Study Summary
The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus. Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.
Primary Outcome
The primary objective is to evaluate the clinical efficacy of three doses of CC-220 (0.45 mg once per day \[QD\], 0.3 mg QD or 0.15 mg QD) compared to placebo, for the treatment of active systemic lupus erythematosus (SLE) using the SLE Responder Index at Week 24 Composite endpoint SRI(4), defined by the following criteria: - Reduction from Baseline of ≥ 4 points in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K score and - No new one or more British Isles Lupus Assessment G
Interventions
- OTHER Placebo
- DRUG CC-220
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2017-08-31 |
| Est. Completion | 2021-08-03 |
| Phase | Phase 2 |
What the finished NCT03161483 record still lists
NCT03161483 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03161483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03161483 about?
NCT03161483 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus". The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus. Approximately 280 subjects with a documented diagnosis o...
What is the current status of trial NCT03161483?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 289 participants. The study started on 2017-08-31. Estimated completion is 2021-08-03.
What interventions are being tested in trial NCT03161483?
The interventions under investigation include: Placebo (OTHER), CC-220 (DRUG).
Who is sponsoring clinical trial NCT03161483?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03161483's enrollment target sits among peer trials
289 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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
- NCT06465199 · 289 participants · Phase 1
Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas
- NCT00775476 · 290 participants · Phase 2
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine
- NCT01874197 · 290 participants · NA
Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic
- NCT04331353 · 290 participants · NA
The Allergen Reduction and Child Health Study (ARCHS)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI