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

SexALL

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

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

Pharmacokinetic profile(Tmax)

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

SexALL

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

Pharmacokinetic profile(Tmax)