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)

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)

Study Overview

• Status: Recruiting
• Conditions: Cryopyrin-associated Periodic Syndromes (CAPS)
• Intervention / Treatment: Drug: JTE-162

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Takanori Nemoto, M.S.; Phone Number: 609-919-9570; Email: ClinicalTrials@akrospharma.com
• Study Contact Backup: Name: Kala Patel, R.Ph., RAC; Phone Number: 609-919-9570; Email: ClinicalTrials@akrospharma.com

Study Locations

• Canada
  • Ontario
    • North York, Ontario, Canada, M3B 3S6
      • Recruiting
      • Gordon Sussman Clinical Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JTE-162 Tablets; Dose 1 once daily for 2 Weeks	Drug: JTE-162; Tablets containing JTE-162

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Akros Pharma Inc.
• Collaborators: PPD Development, LP

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Pharmacokinetics; Tolerability; CAPS; Cryopyrin-associated periodic syndromes; JTE-162
• Additional Relevant MeSH Terms: Chronic Inducible Urticaria; Chronic Urticaria; Cold Urticaria; Pathologic Processes; Chronic Disease; Disease Attributes; Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases, Genetic; Hereditary Autoinflammatory Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Cryopyrin-Associated Periodic Syndromes
• Other Study ID Numbers: AE162-X-24-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No