Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02531633 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 161
- Enrollment target
NCT02531633 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 161 participants.
The verdict
NCT02531633, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 161 participants
- Enrollment target
Study Summary
Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active GCA. The study will be conducted in 2 distinct parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the option to receive open-label sirukumab based on disease status and a 16-week follow-up phase if applicable. Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable only for those who are withdrawn prematurely from the study or whose open-label sirukumab treatment in Part B completes after Week 88.
Interventions
- DRUG Prednisone
- DRUG Sirukumab
- DRUG Placebo to match sirukumab
- DRUG Placebo to match prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2015-10-16 |
| Est. Completion | 2018-03-21 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02531633
The ClinicalTrials.gov registry entry for NCT02531633 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.
NCT02531633 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02531633 about?
NCT02531633 is a clinical study titled "Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis". Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic pathways. Sirukumab inhibit...
What is the current status of trial NCT02531633?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 161 participants. The study started on 2015-10-16. Estimated completion is 2018-03-21.
What interventions are being tested in trial NCT02531633?
The interventions under investigation include: Prednisone (DRUG), Sirukumab (DRUG), Placebo to match sirukumab (DRUG), Placebo to match prednisone (DRUG).
Who is sponsoring clinical trial NCT02531633?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.