Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07247266

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)

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cryopyrin-associated Periodic Syndromes (CAPS) Chronic Disease Chronic Inducible Urticaria Chronic Urticaria Cold Urticaria Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cryopyrin-Associated Periodic Syndromes Disease Attributes Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gordon Sussman Clinical Research Inc.

North York, Ontario, M3B 3S6, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JTE-162

Drug

Tablets containing JTE-162

Primary outcomes

  1. Change and percent change from baseline to end of treatment (EOT) in high-sensitivity C-reactive protein (hs-CRP)

    Time frame: 2 Weeks

  2. Change and percent change from baseline to EOT in Serum amyloid A (SAA)

    Time frame: 2 Weeks

  3. Change and percent change from baseline to EOT in Interleukin (IL)-6

    Time frame: 2 Weeks

  4. Change and percent change from baseline to EOT in Key symptom score (KSS)

    Time frame: 2 Weeks

  5. Change and percent change from baseline to EOT in Individual symptom score on Daily Health Assessment Form, Second Generation (DHAF2)

    Time frame: 2 Weeks

  6. Change and percent change from baseline to EOT in Global assessments of disease activity on DHAF2

    Time frame: 2 Weeks

  7. Change and percent change from baseline to EOT in Global CAPS symptom assessment by the Investigator

    Time frame: 2 Weeks

  8. Change and percent change from baseline to EOT in Individual CAPS symptom assessment by the Investigator

    Time frame: 2 Weeks

  9. Number of adverse events

    Time frame: 4 Weeks

  10. JTE-162 post-dose plasma concentrations on Day 1

    Time frame: 1 Day

  11. JTE-162 trough plasma concentrations on Days 2, 3 and 4, and at the Week 2 Visit (Day 15±2)

    Time frame: Day 2, Day 3, Day 4 and Day 15±2

Study contacts

Contact information is provided by the study sponsor or research team.

Kala Patel, R.Ph., RAC

CONTACT

[email protected]

609-919-9570

Takanori Nemoto, M.S.

CONTACT

[email protected]

609-919-9570

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Collaborators

  • PPD Development, LP

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.