NCT07247266

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
7mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

November 18, 2025

Last Update Submit

February 5, 2026

Conditions

Cryopyrin-associated Periodic Syndromes (CAPS)

Keywords

JTE-162EfficacySafetyTolerabilityCryopyrin-associated periodic syndromesCAPSPharmacokinetics

Outcome Measures

Primary Outcomes (11)

  • 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

Study Arms (1)

JTE-162 Tablets

EXPERIMENTAL

Dose 1 once daily for 2 Weeks

Drug: JTE-162

Interventions

JTE-162DRUG

Tablets containing JTE-162

JTE-162 Tablets

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gordon Sussman Clinical Research Inc.

North York, Ontario, M3B 3S6, Canada

RECRUITING

MeSH Terms

Conditions

Cryopyrin-Associated Periodic Syndromes

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesChronic Inducible UrticariaChronic UrticariaUrticariaSkin Diseases, VascularCold UrticariaHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Takanori Nemoto, M.S.

CONTACT

609-919-9570ClinicalTrials@akrospharma.com

Kala Patel, R.Ph., RAC

CONTACT

609-919-9570ClinicalTrials@akrospharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

February 2, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)