Drugs / Sifalimumab
Sifalimumab
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00482989 | Jun 2007 → Jul 2010 | lupus erythematosus | MedImmune LLC | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01283139 | Mar 2011 → Nov 2013 | systemic lupus erythematosus | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT00979654 | Aug 2010 → Mar 2015 | systemic lupus erythematosus | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT01031836 | Nov 2009 → Nov 2012 | systemic lupus erythematosus | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00657189 | Jul 2008 → May 2010 | systemic lupus erythematosus | MedImmune LLC | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT00533091 Comparator | Apr 2008 → Aug 2010 | idiopathic inflammatory myopathy | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT00472758 Comparator | Feb 2007 → Feb 2008 | psoriasis | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT00299819 Comparator | Mar 2006 → Oct 2007 | systemic lupus erythematosus | MedImmune LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2014-11-11 | AstraZeneca | Results AstraZeneca to present new data from its growing inflammation and autoimmunity pipeline at American College of Rheumatology 2014 Annual Meeting astrazeneca.com ↗
Positive results from the Phase IIb study evaluating the safety and efficacy of sifalimumab |
| 2014-05-12 | AstraZeneca | Results AstraZeneca announces MedImmune’s mavrilimumab and sifalimumab both met primary endpoints in Phase IIb studies astrazeneca.com ↗
The study met its primary endpoint of percentage of subjects that responded by the SLE Responder Index (SRI-4) at Day 365. |
All press releases naming this drug 2 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sifalimumab | “Sifalimumab is a fully human immunoglobulin G1κ monoclonal antibody that binds to and neutralizes a majority of the subtypes of human interferon-α.” PMID 23754736 ↗ Nov 2013 |
| Known as | MDX-1103 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743069 ↗ |
| Known as | MEDI-545 | “A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose, Intravenously Administered...” NCT00472758 ↗8“The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.” NCT00657189 ↗ “Sifalimumab (MEDI-545) 500 or 600 milligram (mg)” NCT00979654 ↗ “Biological: MEDI 545” NCT00299819 ↗ |
| Action | Inhibit | “Anti-Interferon-Alpha” NCT00472758 ↗ |
| Modality | Monoclonal antibody | “a fully human anti-interferon α monoclonal antibody” PMID 21798883 ↗ Jul 2011 |
| Route | Intravenous | “intravenously administered MEDI-545” NCT00299819 ↗ |