Janssen announced two new Phase 3 clinical trials for psoriasis for its investigational drug guselkumab. The company intends to explore the therapeutic use of guselkumab for psoriatic arthritis, but also aims to compare the effectiveness of guselkumab with Cosentyx (secukinumab) for moderate to severe plaque-type psoriasis.
Guselkumab is a monoclonal antibody that targets a well-known molecule involved in the progression of psoriasis, interleukin-23. Developed by Janssen and produced by MorphoSys using its HuCAL antibody library technology, this potential therapy was shown to be effective and safe for the treatment of psoriatic arthritis (PsA) and plaque psoriasis.
Previous results from VOYAGE 1 (NCT02207231), VOYAGE 2 (NCT02207244) and NAVIGATE (NCT02203032) Phase 3 clinical trials have already demonstrated the superiority of guselkumab over Humira (adalimumab) and Stelara (ustekinumab) as treatment for moderate to severe plaque psoriasis.
These studies have shown clinically meaningful results of guselkumab, such as significant improvements in skin clearance. Indeed, 70% of guselkumab-treated patients achieved a near complete skin clearance compared to 2.4% of patients on the placebo-treated arm.
Currently recruiting participants, the randomized ECLIPSE study (NCT03090100) plans to enroll about 1,040 adult patients with moderate to severe plaque psoriasis. Patients will receive either the company’s investigational drug or Cosentyx injections for up to 44 weeks, and will be followed for a total of 56 weeks.
Janssen expects to confirm that guselkumab’s safety and effectiveness profiles are not inferior to those of the currently used treatment.
The new Phase 3 trial on psoriatic arthritis is expected to begin enrolling participants later this year.
Janssen has applied for a priority review voucher to expedite the approval process of its biologics license application (BLA) it filed for guselkumab for moderate to severe plaque-type psoriasis. Depending on a positive decision by the U.S. Food and Drug Administration (FDA), Janssen anticipates a potential U.S. approval for guselkumab in the third quarter of 2017.
“Following on from our licensee Janssen’s successful Phase 3 studies VOYAGE 1, VOYAGE 2, and NAVIGATE in moderate to severe plaque psoriasis and the regulatory filings for approval submitted in the U.S. and Europe, we were delighted to learn of Janssen’s recent update on guselkumab,” Dr. Simon Moroney, CEO of MorphoSys AG, said in a press release.