Recruiting
Phase 1

JTE-162

Sponsor:

Akros Pharma Inc.

Code:

NCT07247266

Conditions

Cryopyrin-associated Periodic Syndromes (CAPS)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

JTE-162

Study Details

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)

Conditions

Cryopyrin-associated Periodic Syndromes (CAPS)

Study ID

NCT07247266

Start date

Feb 2, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JTE-162 Tablets

Dose 1 once daily for 2 Weeks

Interventions

JTE-162

Tablets containing JTE-162

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Takanori Nemoto, M.S.

609-919-9570ClinicalTrials@akrospharma.com

Kala Patel, R.Ph., RAC

609-919-9570ClinicalTrials@akrospharma.com

Locations

Gordon Sussman Clinical Research Inc.

Recruiting

North York, Ontario, Canada, M3B 3S6

More Information

Sponsor

Akros Pharma Inc.

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Akros Pharma Inc. on 2026-02-09.