This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-162 administered once daily for 2 weeks in subjects with cryopyrin-associated periodic syndrome (CAPS)
Clinical History: At least 2 typical clinical symptoms (e.g., urticarial skin rash, myalgia, arthralgia, recurrent fever, fatigue/malaise, conjunctivitis or other autoinflammatory symptoms) prior to the Screening Visit; AND
Genetic Confirmation: Confirmed nucleotide-binding and oligomerization domain (NOD)-like receptor family pyrin domain containing 3 (NLRP3) mutation;
Willing to discontinue current anti-interleukin (IL)-1 treatment, if applicable;
Demonstrates de novo flaring of CAPS during the Screening Period.
Has chronic infantile neurologic cutaneous articular syndrome (CINCA)/neonatal-onset multisystem inflammatory disease (NOMID);
Has a history or presence of amyloidosis, progressive hearing loss, organ damage or any symptom contraindicating anti-IL-1 treatment washout;
Has active systemic bacterial, fungal or viral infection(s) within 14 days prior to Day 1 or a history of clinically significant recurrent infectious diseases
Single group
JTE-162
DrugTablets containing JTE-162
Change and percent change from baseline to end of treatment (EOT) in high-sensitivity C-reactive protein (hs-CRP)
Change and percent change from baseline to EOT in Serum amyloid A (SAA)
Change and percent change from baseline to EOT in Interleukin (IL)-6
Change and percent change from baseline to EOT in Key symptom score (KSS)
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Akros Pharma Inc.
Lead sponsor
PPD Development, LP
Collaborator
