RecruitingPhase 1

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

Canada5 participantsStarted 2026-02-02

Plain-language 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)

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 2 Weeks

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

Timeframe: 2 Weeks

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

Timeframe: 2 Weeks

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

Timeframe: 2 Weeks

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

Timeframe: 2 Weeks

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

Timeframe: 2 Weeks

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

Trial details

NCT IDNCT07247266

SponsorAkros Pharma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Takanori Nemoto, M.S.

609-919-9570 ClinicalTrials@akrospharma.com

View on ClinicalTrials.gov More Cryopyrin-associated Periodic Syndromes (CAPS) trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 2 Weeks

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

Timeframe: 2 Weeks

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

Timeframe: 2 Weeks

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

Timeframe: 2 Weeks

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

Timeframe: 2 Weeks

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

Timeframe: 2 Weeks

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