Recruiting NCT07247266
Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JTE-162.
- Who it may be relevant to
- Registry conditions: Cryopyrin-associated Periodic Syndromes (CAPS). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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)
Overview
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)
Interventions
- Drug JTE-162
Tablets containing JTE-162
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Gordon Sussman Clinical Research Inc. — North York
Identifiers
NCT: NCT07247266 · AE162-X-24-003