Actively Recruiting
Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)
Led by Akros Pharma Inc. · Updated on 2026-02-09
5
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
A
Akros Pharma Inc.
Lead Sponsor
P
PPD Development, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of JTE-162 in Subjects With Cryopyrin-Associated Periodic Syndrome (CAPS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with familial cold autoinflammatory syndrome (FCAS) or Muckle-Wells syndrome (MWS) confirmed by clinical history with at least 2 typical symptoms prior to screening and confirmed NLRP3 mutation
- Willing to discontinue current anti-interleukin-1 treatment if applicable
- Shows new flare-up of CAPS symptoms during screening period
You will not qualify if you...
- Has chronic infantile neurologic cutaneous articular syndrome (CINCA)/neonatal-onset multisystem inflammatory disease (NOMID)
- History or presence of amyloidosis, progressive hearing loss, organ damage, or any symptom that prevents stopping anti-IL-1 treatment
- Active systemic bacterial, fungal, or viral infection within 14 days before Day 1 or history of significant recurrent infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gordon Sussman Clinical Research Inc.
North York, Ontario, Canada, M3B 3S6
Actively Recruiting
Research Team
T
Takanori Nemoto, M.S.
CONTACT
K
Kala Patel, R.Ph., RAC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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