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