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CompletedNCT05812781ExploreUpdated Mar 10, 2025

A Study to Evaluate VTX2735 in Patients With Cryopyrin-associated Periodic Syndrome

A Phase 2 interventional study of VTX2735 and VTX2735 in Cryopyrin Associated Periodic Syndrome, sponsored by Zomagen Biosciences Ltd.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by Zomagen Biosciences Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2024, 2 years 7 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Mar 2025.
Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Cryopyrin-Associated Period Syndrome (CAPS). Approximately 10 patients will take VTX2735 Dose A or VTX2735 Dose B.

The study consists of a screening/washout period of up to 28 weeks, a 2 week treatment period, a treatment withdrawal period of up to 2 weeks, another 2 week treatment period, and a 4 week follow up period. The maximum length of treatment is 4 weeks.

02

Conditions studied

  • Cryopyrin Associated Periodic Syndrome

Keywords

  • Cryopyrin-Associated Periodic Syndrome
  • Ventyx
  • Zomagen
  • VTX2735
  • CAPS
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 enrollment of 7 is below the median of 19 across 25 interventional studies indexed under Cryopyrin-Associated Periodic Syndromes.

Browse Cryopyrin-Associated Periodic Syndromes studies →

Lead sponsor

Zomagen Biosciences Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • At least 18 years of age
  • Diagnosis of CAPS and FCAS subtype and mild clinical phenotype
  • At least one flare during screening/washout
  • Women must not be of childbearing potential or must agree to use two methods of highly effective contraception during the study and for 30 days after the last dose of the study product
  • Men with a partner who is of childbearing potential must agree to use condoms plus another highly effective form of birth control during the study and for 90 days after the last dose of study product

Exclusion criteria

Exclusion Criteria:

  • Unwilling to comply with washout of anti-IL-1 therapy and tolerate symptoms of disease flare
  • Moderate or severe CAPS manifestations or significant damage or any CAPS feature that presents a contraindication to washout of anti-IL-1 therapy
  • Has a history of chronic or recurrent infectious disease
  • Has a known immune deficiency or is immunocompromised
  • Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB)
  • Has another clinically important medical disorder that would compromise safety
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Drug: VTX2735

  • Experimental
    Cohort 2

    Drug: VTX2735

Interventions

  • DrugVTX2735

    Dose A

  • DrugVTX2735

    Dose B

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability of VTX2735

    Incidence and severity of treatment-emergent adverse events (TEAE), serious adverse events (SAE), and discontinuation due to adverse events

    Time frame: From the initial administration of VTX2735 through study completion, up to 10 weeks

Secondary outcomes

  1. Mean change in the mean key symptom score (KSS) derived from the Daily Health Assessment Form, Second Generation (DHAF2) from baseline

    Assess the change from baseline in disease activity using DHAF2 and KSS.

    Time frame: From Day 1 to completion of treatment with VTX2735, up to Day 28

  2. Achievement of 30%, 50%, or 75% improvement in mean KSS from baseline

    Proportion of patients achieving 30%, 50%, or 75% improvement from baseline in disease activity using DHAF2 and KSS.

    Time frame: From Day 1 to completion of treatment with VTX2735, up to Day 28

  3. Number of days when the daily KSS is >3

    Number of multi-system disease flare days as defined by KSS

    Time frame: From Day 1 to completion of treatment with VTX2735, up to Day 28

  4. Number of days when any single DHAF2 symptom score is >3

    Number of single system disease flare days as defined by KSS

    Time frame: From Day 1 to completion of treatment with VTX2735, up to Day 28

  5. Maximum severity of any symptom score on DHAF2

    Maximum single DHAF2 symptom score

    Time frame: From Day 1 to completion of treatment with VTX2735, up to Day 28

07

Study locations

2 sites
  • Local Site # 222
    San Diego, California 92123, United States
  • Local Site # 223
    Columbus, Georgia 31904, United States
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 Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05812781
Lead sponsor
Zomagen Biosciences Ltd.
Responsible party
Sponsor
First posted
Apr 14, 2023
Start date
Mar 18, 2023
Primary completion
Mar 6, 2024
Completion
Mar 6, 2024
Last update
Mar 10, 2025

Study contacts

Henrik Sonnergren, MD, PhD
study director · Ventyx Biosciences, Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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