Janssen Research & Development announced that guselkumab demonstrated positive results in the Phase 3 VOYAGE 1 study investigating its effectiveness and safety in patients with moderate-to-severe plaque psoriasis. According to a recent Janssen press release, the study met its two co-primary endpoints at week 16.
The positive data, from one of three Phase 3 studies evaluating this treatment in psoriasis patients, were presented at the 25th congress of the European Academy of Dermatology and Venereology (EADV), which took place Sept. 28-Oct. 3 in Vienna.
VOYAGE 1 (NCT02207231) is a multicenter, randomized, double-blind Phase 3 study currently evaluating the efficacy and safety of guselkumab versus placebo, and the active comparator Humira (adalimumab), in 843 subjects.
Patients were randomly assigned to one of three groups: Those in group one were being given guselkumab at 100 mg at weeks 0, 4 and 12, followed by every eight-week dosing; those in group two were being given placebo at weeks 0, 4 and 12, followed by treatment with guselkumab at weeks 16 and 20, followed by every eight-week dosing; and group three, the comparator group, was receiving Humira at 80 mg at week 0, and 40 mg at week 1, followed by every two-week dosing. This group is switching to guselkumab, 100 mg, at week 52.
Reported results showed that compared with patients treated with the placebo (6.9%), a higher proportion (85.1%) of patients treated with guselkumab had clear or minimal disease (as measured by the IGA Score) at week 16. A higher proportion of patients (73.3%) treated with guselkumab also had improvements in the Psoriasis Area Severity Index, meaning a PASI 90 response or nearly entirely cleared skin, while only 2.9% of patients treated with placebo achieved this mark.
The results also demonstrated the clinical superiority of guselkumab versus Humira (a tumor necrosis factor blocker). This was observed across all major endpoints of the clinical trial. Specifically, when treatment with guselkumab was compared to Humira all study endpoints reached statistically significant results, as assessed at weeks 24 and 48.
Guselkumab, part of MorphoSys‘s HuCAL antibody library, is a monoclonal antibody designed to block interleukin-23, a cytokine that plays an important role in managing the immune system and autoimmune diseases such as psoriasis.
“We are excited about the positive results released by our licensee Janssen with respect to guselkumab in the treatment of moderate to severe plaque psoriasis,” said Dr. Marlies Sproll, chief scientific officer of MorphoSys AG, in a press release. “We are proud of our long-standing collaboration with Janssen and we are looking forward to the further updates about the development of guselkumab going forward.”
VOYAGE 1 is part of a comprehensive guselkumab Phase 3 clinical development program. Janssen expects to present additional data analyses from VOYAGE 1, and data from two other Phase 3 trials, VOYAGE 2 (NCT02207244) and NAVIGATE (NCT02203032), at future scientific meetings. More information about the clinical trials can be found here.
