A 12-week Dose-Ranging Trial in Patients With Moderate to Severe Plaque Psoriasis
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
IMO 8400 is a second-generation oligonucleotide antagonist of endosomal Toll-like receptors
(TLR) 7, TLR8 and TLR9. These TLR react to complexes of exogenous nucleic acids (as might be
encountered during infection) and endogenous nucleic acids (as might be released during
tissue damage during autoimmune disease). In vitro and in multiple animal models of
autoimmune disease, IMO-8400 blocks immune activation mediated through TLR7, 8 and 9. In
Phase 1 studies (Protocol 8400-001) IMO 8400 has been administered to healthy adults by SC
injection at single-doses and multiple-doses (4 weeks) up to 0.6 mg/kg. All treatments were
well-tolerated, with mild injection site reactions and no pattern of systemic reactions or
laboratory changes.
The current study represents the first clinical trial of IMO-8400 in patients with active
autoimmune disease. Moderate to severe plaque psoriasis was chosen for this 12-week proof of
activity trial based on a prior 4-week study using a first generation TLR7 and 9 antagonist
which demonstrated clinical improvement in this patient population.