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

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ClinicalTrials.gov Identifier: NCT05812781
Recruitment Status : Completed
First Posted : April 14, 2023
Last Update Posted : March 18, 2024
Sponsor:
Information provided by (Responsible Party):
Ventyx Biosciences, Inc ( Zomagen Biosciences, Ltd )

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Cryopyrin Associated Periodic Syndrome Drug: VTX2735 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2A, Single-Arm Study to Evaluate the Safety and Clinical Activity of VTX2735 in Participants With Cryopyrin-Associated Periodic Syndrome (CAPS)
Actual Study Start Date : March 18, 2023
Actual Primary Completion Date : March 6, 2024
Actual Study Completion Date : March 6, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 Drug: VTX2735
Dose A
Experimental: Cohort 2 Drug: VTX2735
Dose B


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability of VTX2735 [ Time Frame: From the initial administration of VTX2735 through study completion, up to 10 weeks ]
    Incidence and severity of treatment-emergent adverse events (TEAE), serious adverse events (SAE), and discontinuation due to adverse events


Secondary Outcome Measures :
  1. Mean change in the mean key symptom score (KSS) derived from the Daily Health Assessment Form, Second Generation (DHAF2) from baseline [ Time Frame: From Day 1 to completion of treatment with VTX2735, up to Day 28 ]
    Assess the change from baseline in disease activity using DHAF2 and KSS.

  2. Achievement of 30%, 50%, or 75% improvement in mean KSS from baseline [ Time Frame: From Day 1 to completion of treatment with VTX2735, up to Day 28 ]
    Proportion of patients achieving 30%, 50%, or 75% improvement from baseline in disease activity using DHAF2 and KSS.

  3. Number of days when the daily KSS is >3 [ Time Frame: From Day 1 to completion of treatment with VTX2735, up to Day 28 ]
    Number of multi-system disease flare days as defined by KSS

  4. Number of days when any single DHAF2 symptom score is >3 [ Time Frame: From Day 1 to completion of treatment with VTX2735, up to Day 28 ]
    Number of single system disease flare days as defined by KSS

  5. Maximum severity of any symptom score on DHAF2 [ Time Frame: From Day 1 to completion of treatment with VTX2735, up to Day 28 ]
    Maximum single DHAF2 symptom score


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05812781


Locations
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United States, California
Local Site # 222
San Diego, California, United States, 92123
United States, Georgia
Local Site # 223
Columbus, Georgia, United States, 31904
Sponsors and Collaborators
Zomagen Biosciences, Ltd
Investigators
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Study Director: Matt Cascino, MD Ventyx Biosciences, Inc
More Information
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Responsible Party: Zomagen Biosciences, Ltd
ClinicalTrials.gov Identifier: NCT05812781    
Other Study ID Numbers: VTX2735-201
First Posted: April 14, 2023    Key Record Dates
Last Update Posted: March 18, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ventyx Biosciences, Inc ( Zomagen Biosciences, Ltd ):
Cryopyrin-Associated Periodic Syndrome
Ventyx
Zomagen
VTX2735
CAPS
Additional relevant MeSH terms:
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Cryopyrin-Associated Periodic Syndromes
Syndrome
Disease
Pathologic Processes
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Chronic Inducible Urticaria
 Chronic Urticaria
Urticaria
Skin Diseases, Vascular
Cold Urticaria
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Chronic Disease
Disease Attributes