HL2351 CAPS Phase II Study

January 3, 2017 updated by: Handok Inc.

An Open Label, Single Arm Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of HL2351 in Patients With Cryopyrin Associated Periodic Syndromes

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HL2351
Drug: HL2351
The dose will be adjusted based on disease activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Diary Symptom Sum Score (DSSS)
Time Frame: from baseline to Month 6
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
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
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
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
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
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
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
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
0,12,24,36,48,72,96,144,168 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Investigators

  • Principal Investigator: JOONG GON KIM, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (ESTIMATE)

August 2, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL_C201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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