Cohort 1 for Cryopyrin-Associated Periodic Syndromes

Local Site # 222, San Diego, CA
Cryopyrin-Associated Periodic SyndromesVTX2735 - Drug
Eligibility
18+
All Sexes

Study Summary

This trial will test if VTX2735 is safe/effective for treating Cryopyrin-Associated Period Syndrome (CAPS) in 10 patients, over a max of 4 weeks.

Eligible Conditions
  • Cryopyrin-Associated Periodic Syndromes (CAPS)

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 5 Secondary · Reporting Duration: From Day 1 to completion of treatment with VTX2735, up to Day 28

Day 28
Achievement of 30%, 50%, or 75% improvement in mean KSS from baseline
Maximum severity of any symptom score on DHAF2
Mean change in the mean key symptom score (KSS) derived from the Daily Health Assessment Form, Second Generation (DHAF2) from baseline
Number of days when any single DHAF2 symptom score is >3
Number of days when the daily KSS is >3
Week 10
Safety and Tolerability of VTX2735

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
Computed Tomography
1
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1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Cohort 1
1 of 2
Cohort 2
1 of 2

Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: Cohort 1 · No Placebo Group · Phase 2

Cohort 1
Drug
Experimental Group · 1 Intervention: VTX2735 · Intervention Types: Drug
Cohort 2
Drug
Experimental Group · 1 Intervention: VTX2735 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from day 1 to completion of treatment with vtx2735, up to day 28

Who is running the clinical trial?

Zomagen Biosciences, LtdLead Sponsor
Matt Cascino, MDStudy DirectorVentyx Biosciences, Inc
1 Previous Clinical Trials
195 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You experienced a sudden increase in symptoms during the screening/washout period.
References

Frequently Asked Questions

How likely are individuals to experience adverse effects when participating in Cohort 1?

"Since Cohort 1 is currently being trialled in Phase 2, our team at Power has estimated its safety to be a score of 2. This rating indicates that there are data that support the drug's security, but no evidence indicating how effective it may be." - Anonymous Online Contributor

Unverified Answer

Is recruitment for this research project still taking place?

"Affirmative, the information hosted on clinicaltrials.gov indicates that this research project is currently looking for participants. Initially posted on March 18th 2023, and recently updated in April 11th of the same year; 10 patients will be accepted from two specific locations." - Anonymous Online Contributor

Unverified Answer

How many participants are engaged in this research?

"Affirmative. Information accessed via clinicaltrials.gov reveals that this research endeavour, which was originally posted on March 18th 2023, is currently enrolling participants. The investigation desires 10 patients to be recruited from 2 distinct medical facilities." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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