TerminatedPhase 2

HL2351 CAPS Phase II Study

Stopped: difficult of recruiting

South Korea8 participantsStarted 2015-10

Plain-language summary

This is an open label, single arm trial to evaluate the efficacy, safety, and pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes (CAPS).

Who can participate

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: * Documented molecular diagnosis of NALP3 mutation or diagnosis of CAPS based on sign and symptom * Diagnosis of CAPS based on signs and symptoms * Current stable doses of anakinra, alone or in combination with methotrexate or corticosteroids Exclusion Criteria: * Patient been diagnosed with a hereditary periodic fever syndrome or autoinflammatory disease other than CAPS * Patients whose disease is inadequately controlled on current stable doses of anakinra, alone or in combination with methotrexate or corticosteroids

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 in Diary Symptom Sum Score (DSSS)

Timeframe: from baseline to Month 6

Change in SAA, CRP, ESR levels

Timeframe: from baseline to Month 6, from baseline to each visit up to Month 24

Change in physician's global assessment of autoinflammatory using 100mm VAS score disease

Timeframe: from baseline to Month 6, from baseline to each visit up to Month 24

Change in patient's(parents or legal guardians) global assessment of autoinflammatory using 100mm VAS score disease

Timeframe: from baseline to Month 6, from baseline to each visit up to Month 24

Pharmacokinetic profile(Cmax)

Timeframe: 0,12,24,36,48,72,96,144,168 hr

Pharmacokinetic profile(AUClast)

Timeframe: 0,12,24,36,48,72,96,144,168 hr

Pharmacokinetic profile(AUCinf)

Timeframe: 0,12,24,36,48,72,96,144,168 hr

Trial details

NCT IDNCT02853084

SponsorHandok Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05

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

Who can participate

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 in Diary Symptom Sum Score (DSSS)

Timeframe: from baseline to Month 6

Change in SAA, CRP, ESR levels

Timeframe: from baseline to Month 6, from baseline to each visit up to Month 24

Change in physician's global assessment of autoinflammatory using 100mm VAS score disease

Timeframe: from baseline to Month 6, from baseline to each visit up to Month 24

Change in patient's(parents or legal guardians) global assessment of autoinflammatory using 100mm VAS score disease

Timeframe: from baseline to Month 6, from baseline to each visit up to Month 24

Pharmacokinetic profile(Cmax)

Timeframe: 0,12,24,36,48,72,96,144,168 hr

Pharmacokinetic profile(AUClast)

Timeframe: 0,12,24,36,48,72,96,144,168 hr

Pharmacokinetic profile(AUCinf)

Timeframe: 0,12,24,36,48,72,96,144,168 hr