Clinical Trial: HL2351 CAPS Phase II Study
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Open Label, Single Arm Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of HL2351 in Patients With Cryopyrin Associated Periodic Syndromes
Brief 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).
Detailed Summary: This trial enrolls patients with CAPS being on stable dose of anakinra daily and then switch over HL2351 given once weekly. It consists of 4 phases, 6-week screening, single dose PK, 6-month multiple dose, and 18-month extension phase.
Sponsor: Handok Pharmaceuticals Co., Ltd.
Current Primary Outcome:
- Change in Diary Symptom Sum Score (DSSS) [ Time Frame: from baseline to Month 6 ]
- Change in SAA, CRP, ESR levels [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: from baseline to Month 6, from baseline to each visit up to Month 24 ]
- Pharmacokinetic profile(Cmax) [ Time Frame: 0,12,24,36,48,72,96,144,168 hr ]
- Pharmacokinetic profile(AUClast) [ Time Frame: 0,12,24,36,48,72,96,144,168 hr ]
- Pharmacokinetic profile(AUCinf) [ Time Frame: 0,12,24,36,48,72,96,144,168 hr ]
- Pharmacokinetic profile(Tmax) [ Time Frame: 0,12,24,36,48,72,96,144,168 hr ]
- Pharmacokinetic profile(t1/2) [ Time Frame: 0,12,24,36,48,72,96,144,168 hr ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Handok Pharmaceuticals Co., Ltd.
Dates:
Date Received: May 10, 2016
Date Started: October 2015
Date Completion: January 2019
Last Updated: January 3, 2017
Last Verified: May 2016