Drugs / efalizumab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Raptiva | — | 2009-06-09 | europa.eu ↗ |
| Approved | EU (EMA) | Raptiva | — | 2004-09-20 | europa.eu ↗ |
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT00676559 | Apr 2008 → Apr 2009 | diabetic macular edema | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 1 | NCT00726466 | Mar 2008 → ? | age-related macular degeneration, choroidal neovascularization | Vitreous -Retina- Macula Consultants of New York | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00280826 | Jan 2006 → Feb 2009 | macular retinal edema, uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 1 | NCT00134134 | Feb 2005 → Aug 2006 | hidradenitis suppurativa | NYU Langone Health | Completed | No outcome recorded |
| Phase 1 | NCT00382512 | May 2003 → ? | psoriasis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00051662 | ? → Feb 2004 | psoriatic arthritis | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00777400 | Dec 2008 → Apr 2009 | autoimmune disease | University of California, San Francisco | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT00472082 | May 2007 → Apr 2009 | chronic renal failure syndrome | Emory University | Terminated | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT00737763 | Oct 2008 → Nov 2009 | type 1 diabetes mellitus | Emory University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00746980 | Aug 2008 → Jul 2009 | alopecia totalis | Northwestern University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00276250 | Dec 2005 → Dec 2014 | type 1 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT00146003 | Mar 2005 → Dec 2007 | atopic eczema | University of Medicine and Dentistry of New Jersey | Completed | No outcome recorded |
| Phase 2 | NCT00034203 | Apr 2002 → Aug 2003 | rheumatoid arthritis | XOMA (US) LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00729768 | — | — | Genentech, Inc. | Withdrawn | No outcome recorded |
| Phase 37 trials · 1 met primary | ||||||
| Phase 3 | NCT00442650 | Jan 2004 → Dec 2005 | psoriasis | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 3 | NCT00338143 | Oct 2003 → May 2004 | psoriasis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00115076 | Aug 2003 → May 2009 | psoriasis | Rockefeller University | Completed | No outcome recorded |
| Phase 3 | NCT00256139 | Mar 2003 → Oct 2004 | psoriasis | Merck KGaA, Darmstadt, Germany | Completed | Met primary |
| Phase 3 | NCT00096603 | Oct 2002 → Jul 2004 | psoriasis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00109317 | Sep 2002 → Feb 2003 | psoriasis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00109252 | Jan 2002 → Apr 2003 | psoriasis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 48 trials · 1 missed | ||||||
| Phase 4 | NCT00669214 | Feb 2008 → Jan 2009 | psoriasis | Genentech, Inc. | Completed | Missed primary |
| Phase 4 | NCT00697593 | Jan 2008 → Apr 2009 | psoriasis | Merck KGaA, Darmstadt, Germany | Terminated | No outcome recorded |
| Phase 4 | NCT00336973 | May 2006 → Feb 2008 | psoriasis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00312026 | Mar → Nov 2006 | psoriasis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00302445 | Mar 2006 → Jul 2007 | psoriasis | Derm Research, PLLC | Completed | No outcome recorded |
| Phase 4 | NCT00249808 | Dec 2004 → Jan 2007 | psoriasis | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 4 | NCT00287118 | Oct 2004 → May 2006 | psoriasis | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 4 | NCT00096980 | Feb 2001 → May 2004 | psoriasis | Genentech, Inc. | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT00489216 | Dec 2006 → Jun 2008 | graft versus host disease | UNC Lineberger Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00133107 | Jan → Nov 2005 | lichen planus, oral | Washington University School of Medicine | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 4 | NCT00972543 Comparator | Sep 2008 → May 2009 | psoriasis | Merck KGaA, Darmstadt, Germany | Terminated | No outcome recorded |
| Phase 4 | NCT00707070 Background | Sep 2008 → Oct 2009 | psoriasis | University of Verona | Unknown | No outcome recorded |
| Phase 4 | NCT00739882 Comparator | Apr 2008 → Jun 2009 | psoriasis | Merck KGaA, Darmstadt, Germany | Terminated | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | efalizumab | “Clinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: results from a phase III international...” PMID 16792770 ↗ Jul 2006 |
| Known as | Raptiva | “A Phase IV Open-Label Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Raptiva (Efalizumab) in Adult Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had...” NCT00336973 ↗7“Clinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: results from a phase III international...” PMID 16792770 ↗ Jul 2006 “Efalizumab, known by its trade name Raptiva, was approved by the FDA in October 2003 for the treatment of psoriasis.” NCT00472082 ↗ “Raptiva (efalizumab)” NCT00096980 ↗ “Raptiva (efalizumab)” NCT00096603 ↗ “Raptiva (efalizumab)” NCT00109317 ↗ “Raptiva (efalizumab)” NCT00109252 ↗ “Raptiva (efalizumab)” NCT00382512 ↗ |
| Action | Inhibit | “relapse after ceasing efalizumab (anti-CD11a, Raptiva, Genentech)” PMID 22348003 ↗ Feb 2012 |
| Modality | Monoclonal antibody | “humanized monoclonal antibody (efalizumab)” NCT00034203 ↗ |
| Route | Subcutaneous | “efalizumab administered subcutaneously” NCT00096603 ↗ |
| Target | ITGAL | “humanized anti-CD11a antibody” NCT00280826 ↗ |