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TerminatedNCT02853084Updated Jan 4, 2017

HL2351 CAPS Phase II Study

A Phase 2 interventional study of HL2351 in Cryopyrin-Associated Periodic Syndromes (CAPS), sponsored by Handok Inc.. Terminated at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2017-01-04.

Sponsored by Handok Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
difficult of recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Cryopyrin-Associated Periodic Syndromes (CAPS)

Keywords

  • Auto-inflammatory diseases
  • IL-1 inhibitors
  • HL2351
  • Cryopyrin-Associated Periodic Syndromes (CAPS)
  • Neonatal Onset Multisystem Inflammatory Disease (NOMID)
  • Muckle-Wells Syndrome (MWS)
  • Familial Cold Autoinflammatory Syndrome (FCAS)
03

In context

Cryopyrin-Associated Periodic Syndromes

34 studies on the registry are indexed under Cryopyrin-Associated Periodic Syndromes; 5 are open to participants now.

This study's planned enrollment of 8 is below the median of 19 across 25 interventional studies indexed under Cryopyrin-Associated Periodic Syndromes.

Browse Cryopyrin-Associated Periodic Syndromes studies →

Lead sponsor

Handok Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    HL2351

    Drug: HL2351

Interventions

  • DrugHL2351

    The dose will be adjusted based on disease activities

06

What researchers measure

Primary outcomes

  1. Change in Diary Symptom Sum Score (DSSS)

    Time frame: from baseline to Month 6

  2. Change in SAA, CRP, ESR levels

    Time frame: from baseline to Month 6, from baseline to each visit up to Month 24

  3. 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

  4. 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

  5. Pharmacokinetic profile(Cmax)

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

  6. Pharmacokinetic profile(AUClast)

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

  7. Pharmacokinetic profile(AUCinf)

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

  8. Pharmacokinetic profile(Tmax)

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

  9. Pharmacokinetic profile(t1/2)

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

07

Study locations

1 site
  • Handok Inc.
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02853084
Lead sponsor
Handok Inc.
Responsible party
Sponsor
First posted
Aug 2, 2016
Start date
Oct 2015
Primary completion
May 2017 (estimated)
Completion
Jan 2019 (estimated)
Last update
Jan 4, 2017

Study contacts

JOONG GON KIM
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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