Drugs / Lampalizumab
last change Jun 2018 re-read 3 minutes ago

Lampalizumab

also known as FCFD4514S · anti-FACTOR-D · Anti-fD · RG-7417 · Sn578b8z9q

Monoclonal antibody targets CFD via inhibition

Developed for
diffuse secondary choroid atrophy
Investigated by
Genentech, Inc. · Hoffmann-La Roche

Trials 7

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00973011 Sep 2009 → Jul 2010 diffuse secondary choroid atrophy Genentech, Inc. Completed No outcome recorded
Phase 23 trials · 1 missed
Phase 2 NCT02288559 Mar 2015 → Jun 2017 diffuse secondary choroid atrophy Genentech, Inc. Completed Missed primary
Phase 2 NCT01602120 May 2012 → Nov 2017 diffuse secondary choroid atrophy Genentech, Inc. Terminated No outcome recorded
Phase 2 NCT01229215 Feb 2011 → Apr 2013 diffuse secondary choroid atrophy Genentech, Inc. Completed No outcome recorded
Phase 33 trials · 2 missed
Phase 3 NCT02745119 Jul 2016 → Jan 2018 diffuse secondary choroid atrophy Hoffmann-La Roche Terminated No outcome recorded
Phase 3 NCT02247531 Oct 2014 → Jan 2018 diffuse secondary choroid atrophy Hoffmann-La Roche Terminated Missed primary
Phase 3 NCT02247479 Sep 2014 → Jan 2018 diffuse secondary choroid atrophy Hoffmann-La Roche Terminated Missed primary

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2017-09-08 Hoffmann-La Roche Results Roche provides update on first lampalizumab phase III study for geographic atrophy, an advanced form of age-related macular degeneration roche.com ↗
Lampalizumab did not reduce mean change in GA lesion area compared to sham treatment at 1 year (48 weeks).
2017-09-08 Genentech, Inc. Results Genentech Provides Update on First Lampalizumab Phase III Study for Geographic Atrophy, an Advanced Form of Age-Related Macular Degeneration gene.com ↗
today announced that the primary endpoint has not been met in Spectri, the first of two Phase III studies evaluating the safety and efficacy of lampalizumab

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Lampalizumab ClinicalTrials.gov intervention name — accepted as the source's own label NCT02247531 ↗
4

NCT02745119 ↗

NCT02288559 ↗

NCT01602120 ↗

NCT02247479 ↗

Known as anti-FACTOR-D ChEMBL registry synonym — accepted as the source's own label CHEMBL2109408 ↗
Known as Anti-fD ChEMBL registry synonym — accepted as the source's own label CHEMBL2109408 ↗
Known as FCFD4514S “A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed...” NCT01602120 ↗
2

NCT01229215 ↗

NCT00973011 ↗

Known as RG-7417 ChEMBL registry synonym — accepted as the source's own label CHEMBL2109408 ↗
Known as Sn578b8z9q ChEMBL registry synonym — accepted as the source's own label CHEMBL2109408 ↗
Action Inhibit “lampalizumab, a selective complement factor D inhibitor” PMID 29801123 ↗ Jun 2018
1

“Complement factor D inhibitor” CHEMBL2109408 ↗

Modality Monoclonal antibody — CHEMBL2109408 ↗
Route Intravitreal “Intravitreal escalating dose” NCT00973011 ↗
Target CFD “Complement factor D inhibitor” CHEMBL2109408 ↗