Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)

A Phase 1b, Open-label, Single-arm Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07247266

Enrollment

Registered

2025-11-25

Start date

2026-02-02

Completion date

2026-12-01

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryopyrin-associated Periodic Syndromes (CAPS)

Keywords

JTE-162, Efficacy, Safety, Tolerability, Cryopyrin-associated periodic syndromes, CAPS, Pharmacokinetics

Brief summary

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)

Interventions

DRUGJTE-162

Tablets containing JTE-162

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Diagnosed with familial cold autoinflammatory syndrome (FCAS) or Muckle-Wells syndrome (MWS) confirmed by: * 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Change and percent change from baseline to end of treatment (EOT) in high-sensitivity C-reactive protein (hs-CRP)	2 Weeks
Change and percent change from baseline to EOT in Serum amyloid A (SAA)	2 Weeks
Change and percent change from baseline to EOT in Interleukin (IL)-6	2 Weeks
Change and percent change from baseline to EOT in Key symptom score (KSS)	2 Weeks
Change and percent change from baseline to EOT in Individual symptom score on Daily Health Assessment Form, Second Generation (DHAF2)	2 Weeks
Change and percent change from baseline to EOT in Global assessments of disease activity on DHAF2	2 Weeks
Change and percent change from baseline to EOT in Global CAPS symptom assessment by the Investigator	2 Weeks
Change and percent change from baseline to EOT in Individual CAPS symptom assessment by the Investigator	2 Weeks
Number of adverse events	4 Weeks
JTE-162 post-dose plasma concentrations on Day 1	1 Day
JTE-162 trough plasma concentrations on Days 2, 3 and 4, and at the Week 2 Visit (Day 15±2)	Day 2, Day 3, Day 4 and Day 15±2

Countries

Canada

Contacts

CONTACTTakanori Nemoto, M.S.

ClinicalTrials@akrospharma.com609-919-9570

CONTACTKala Patel, R.Ph., RAC